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Internet-based Physical Activities Randomized Controlled Trial in Mild/Moderate Depression Participants: SONRIE Project (SONRIE)

Primary Purpose

Exercise, Physical Fitness, Depression

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise and psychological intervention
Sponsored by
University of Cadiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise focused on measuring depression, physical activity, exercise, physical fitness, psychological, Endocannabinoids system

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female participants between 25-65 years. Mild and / or moderate depression diagnosed by Beck Scale. Do not have other severe somatic or psychiatric disorders or other diseases that prevents physical activity. To be able to communicate with any problem. To be able to read and understand the main purpose of the study. Informed consent: must be capable and willing to provide consent. Exclusion Criteria: Major depression diagnosed. Acute or terminal illness. History of cerebral infarction, epilepsy, brain tumor. Unstable cardiovascular disease, or other medical conditions. Upper or lower extremity fracture in the past 3 months. Severe visual or auditory problems. Unwillingness to either complete the study requirements or to be randomized into control or training group. To be a participant in another research study that may influence the present project.

Sites / Locations

  • University of Cádiz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control

Arm Description

Group where the participants realize an intervention based on exercise and psychology.

Group where the subjects do not realize the intervention.

Outcomes

Primary Outcome Measures

Depression PRE
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured before the intervention program.
Depression POST
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured immediately after the intervention program.
Depression RET
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured 4 weeks after the intervention program.
Anxiety disorders and stress PRE
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured before the intervention program.
Anxiety disorders and stress POST
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured immediately after the intervention program.
Anxiety disorders and stress RET
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured 4 weeks after the intervention program.
Light physical activity PRE
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Light physical activity POST
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Light physical activity RET
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Moderate physical activity PRE
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Moderate physical activity POST
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Moderate physical activity RET
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Vigorous physical activity PRE
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Vigorous physical activity POST
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Vigorous physical activity RET
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Moderate-Vigorous physical activity PRE
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Moderate-Vigorous physical activity POST
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Moderate-Vigorous physical activity RET
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Cardiorespiratory fitness PRE
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured before the intervention program.
Cardiorespiratory fitness POST
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured immediately after the intervention program.
Cardiorespiratory fitness RET
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured 4 weeks after the intervention program.
30-s chair stand PRE
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured before the intervention program.
30-s chair stand POST
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured immediately after the intervention program.
30-s chair stand RET
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured 4 weeks after the intervention program.
Chair sit and reach PRE
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured before the intervention program.
Chair sit and reach POST
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured immediately after the intervention program.
Chair sit and reach RET
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured 4 weeks after the intervention program.
Back scratch PRE
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured before the intervention program.
Back scratch POST
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured immediately after the intervention program.
Back scratch RET
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured 4 weeks after the intervention program.
Blind flamingo PRE
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured before the intervention program.
Blind flamingo POST
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured immediately after the intervention program.
Blind flamingo RET
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured 4 weeks after the intervention program.
8 ft. up and go PRE
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured before the intervention program.
8 ft. up and go POST
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured immediately after the intervention program.
8 ft. up and go RET
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured 4 weeks after the intervention program.
Handgrip strength PRE
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured before the intervention program.
Handgrip strength POST
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured immediately after the intervention program.
Handgrip strength RET
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured 4 weeks after the intervention program.
Anandamine (AEA) PRE
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
Anandamine (AEA) POST
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
Anandamine (AEA) RET
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
2-araquinodilglicerol (2-AG) PRE
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
2-araquinodilglicerol (2-AG) POST
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
2-araquinodilglicerol (2-AG) RET
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
N-palmitoylethanolamide (PEA) PRE
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
N-palmitoylethanolamide (PEA) POST
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
N-palmitoylethanolamide (PEA) RET
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
N-oleylethanolamine (OEA) PRE
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
N-oleylethanolamine (OEA) POST
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
N-oleylethanolamine (OEA) RET
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
Brain-derived neurotrophic factor PRE
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured before the intervention program.
Brain-derived neurotrophic factor POST
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured immediately after the intervention program.
Brain-derived neurotrophic factor RET
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured 4 weeks after the intervention program.

Secondary Outcome Measures

Ryff's Psychological Well-Being Scale (42-item) PRE
Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294. That measurements will be measured before the intervention program.
Ryff's Psychological Well-Being Scale (42-item) POST
Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294. That measurements will be measured immediately after the intervention program.
Ryff's Psychological Well-Being Scale (42-item) RET
Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294, being 42 the worst score. That measurements will be measured 4 weeks after the intervention program.
The SF-36 Health Questionnaire PRE
The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured before the intervention program.
The SF-36 Health Questionnaire POST
The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured immediately after the intervention program.
The SF-36 Health Questionnaire RET
The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured 4 weeks after the intervention program.
Blood pressure PRE
Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured before the intervention program.
Blood pressure POST
Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured immediately after the intervention program.
Blood pressure RET
Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured 4 weeks after the intervention program.
Heart rate PRE
Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured before the intervention program.
Heart rate POST
Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured immediately after the intervention program.
Heart rate RET
Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured 4 weeks after the intervention program.
Weight PRE
Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured before the intervention program.
Weight POST
Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured immediately after the intervention program.
Weight RET
Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Height PRE
Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured before the intervention program.
Height POST
Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured immediately after the intervention program.
Height RET
Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Waist circumference PRE
Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured before the intervention program.
Waist circumference POST
Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured immediately after the intervention program.
Waist circumference RET
Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Fat mass PRE
Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured before the intervention program.
Fat mass POST
Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured immediately after the intervention program.
Fat mass RET
Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Sociodemographic characteristics questionnaire PRE
Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured before the intervention program.
Sociodemographic characteristics questionnaire POST
Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured immediately after the intervention program.
Sociodemographic characteristics questionnaire RET
Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured 4 weeks after the intervention program.
Food Frequency Questionnaire (FFQ) PRE
food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured before the intervention program.
Food Frequency Questionnaire (FFQ) POST
food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured immediately after the intervention program.
Food Frequency Questionnaire (FFQ) RET
food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured 4 weeks after the intervention program.
Sleep time PRE
Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Sleep time POST
Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Sleep time RET
Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
The Pittsburg Sleep Quality Index PRE
The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured before the intervention program.
The Pittsburg Sleep Quality Index POST
The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured immediately after the intervention program.
The Pittsburg Sleep Quality Index RET
The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured 4 weeks after the intervention program.

Full Information

First Posted
March 24, 2023
Last Updated
April 27, 2023
Sponsor
University of Cadiz
Collaborators
Consejería de Salud y Familia (Junta de Andalucía), Institute of Biomedical research and innovation of Cádiz (INIBICA)
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1. Study Identification

Unique Protocol Identification Number
NCT05849792
Brief Title
Internet-based Physical Activities Randomized Controlled Trial in Mild/Moderate Depression Participants: SONRIE Project
Acronym
SONRIE
Official Title
Internet-based Physical Activities Randomized Controlled Trial in Patients With Mild/Moderate Depression: Effects on Psychological and Social Well-being: SONRIE Project
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cadiz
Collaborators
Consejería de Salud y Familia (Junta de Andalucía), Institute of Biomedical research and innovation of Cádiz (INIBICA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized controlled trial is to determine the effect of an intervention program with physical activity for 12 weeks on depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression. The main questions it aims to answer are: - To determine the association of physical activity levels, sedentary behavior, sleep patterns, physical condition, diet, and general health status with mental and social well-being, and quality of life in a large sample of adult patients diagnosed with mild or moderate depression. - To examine the predictive capacity of physical activity, sedentary behaviors, and physical condition on mild and moderate depressive disorder. - To study the effect of a period without an intervention program with physical activity (8 weeks without exercise intervention) on the variables studied. - To examine the role of the endocannabinoid system on depression as well as its behavior after an intervention program of physical activity. Participants will be involved in a physical activity intervention program for 12 weeks. Researchers will compare intervention group and control group to see if an intervention program with physical activity for 12 weeks improve depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression.
Detailed Description
One hundred and six eligible participants between 25-65 years old (Spanish higher prevalence of depression in adulthood) diagnosed with mild or moderate depression will be the sample of this project. Participants will be recruited from the Mental Health Unit (UGC Salud Mental), covering different areas of the province of Cadiz (Spain) such as Puerto Real, Chiclana de la Frontera and Vejer de la Frontera. The Mental Health Unit Director from Puerto Real Hospital is a researcher associated with this project who has specific experience with clinical experience. He will be the person in charge for the clinical depression diagnosis. Moreover, participants will perform specific depression tests at the time of recruitment to confirm their clinical status. Individuals who meet the criteria to participate in this study will sign the informed consent previously to their inclusion in this project (see inclusion / exclusion criteria section). Sample size and statistical power Sample size determination will be estimated with a 5% type I error (α) and 95% confidence interval establishing a level of precision (d = 0.095) for the hypothesis test to comparing two proportions. The desired sample size will be n = 96 participants and it will be increased by 10% (n = 106) to compensate the possible dropout of participants during the evaluation process of the study. Sample size for the hypothesis test to comparing two means for the intervention study will consider with a significance level alpha of 0.05 and a power of 0.95 (beta = 0.05) and considering the standard deviation for depression variable as 9.36 (Bouldering psychotherapy reduces depressive symptoms even when general physical activity is controlled for: A randomized controlled trial, Heylon, 2018; Mar; 4 (3): e00580). In this way, to detect a minimum mean difference of 8.26 between control and experimental groups for the depression variable, it is estimated that the sample size of each group should be 30 patients. Therefore, a total of 60 participants will be randomly recruited to each group balanced by sex, age and depression clinical severity. It should be taking into account that several simulations to estimate the sample size based on previous studies were performed by STATA statistical software vs. 14.0.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Physical Fitness, Depression, Adult ALL, Psychological
Keywords
depression, physical activity, exercise, physical fitness, psychological, Endocannabinoids system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Group where the participants realize an intervention based on exercise and psychology.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Group where the subjects do not realize the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Exercise and psychological intervention
Intervention Description
Physical Exercise Intervention Sixty-minute sessions were delivered via internet, three times per week (1 supervised) over the first four weeks of the COVID-19 home confinement. The intervention was a multicomponent exercise program lead by a specialist in fitness composed of aerobic, resistance, balance, coordination, mobility and stretching exercises. Each multicomponent exercise session consisted of a 10 min warm-up, 40 min of moderate to vigorous intensity physical activity, and 10 min cool down. Psychological intervention The internet-based-psychological intervention provided to different component of Cognitive Behavioral Therapy (CBT) guided and recorded by a sport neuro-psychologist specialist. The iCBT is based on the protocol for face-to-face CBT for depression. The program consisted of 4 weeks composed of 2 weekly video-guided sessions, with a maximum duration of 30 minutes. iCBT was focused on 4 main axes of action physiological, emotional, behavioral and cognitive.
Primary Outcome Measure Information:
Title
Depression PRE
Description
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Depression POST
Description
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Depression RET
Description
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Anxiety disorders and stress PRE
Description
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Anxiety disorders and stress POST
Description
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Anxiety disorders and stress RET
Description
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Light physical activity PRE
Description
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Light physical activity POST
Description
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Light physical activity RET
Description
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Moderate physical activity PRE
Description
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Moderate physical activity POST
Description
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Moderate physical activity RET
Description
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Vigorous physical activity PRE
Description
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Vigorous physical activity POST
Description
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Vigorous physical activity RET
Description
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Moderate-Vigorous physical activity PRE
Description
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Moderate-Vigorous physical activity POST
Description
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Moderate-Vigorous physical activity RET
Description
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Cardiorespiratory fitness PRE
Description
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Cardiorespiratory fitness POST
Description
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Cardiorespiratory fitness RET
Description
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
30-s chair stand PRE
Description
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
30-s chair stand POST
Description
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
30-s chair stand RET
Description
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Chair sit and reach PRE
Description
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Chair sit and reach POST
Description
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Chair sit and reach RET
Description
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Back scratch PRE
Description
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Back scratch POST
Description
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Back scratch RET
Description
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Blind flamingo PRE
Description
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Blind flamingo POST
Description
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Blind flamingo RET
Description
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
8 ft. up and go PRE
Description
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
8 ft. up and go POST
Description
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
8 ft. up and go RET
Description
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Handgrip strength PRE
Description
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Handgrip strength POST
Description
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Handgrip strength RET
Description
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Anandamine (AEA) PRE
Description
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Anandamine (AEA) POST
Description
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Anandamine (AEA) RET
Description
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
2-araquinodilglicerol (2-AG) PRE
Description
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
2-araquinodilglicerol (2-AG) POST
Description
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
2-araquinodilglicerol (2-AG) RET
Description
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
N-palmitoylethanolamide (PEA) PRE
Description
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
N-palmitoylethanolamide (PEA) POST
Description
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
N-palmitoylethanolamide (PEA) RET
Description
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
N-oleylethanolamine (OEA) PRE
Description
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
N-oleylethanolamine (OEA) POST
Description
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
N-oleylethanolamine (OEA) RET
Description
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Brain-derived neurotrophic factor PRE
Description
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Brain-derived neurotrophic factor POST
Description
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Brain-derived neurotrophic factor RET
Description
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Secondary Outcome Measure Information:
Title
Ryff's Psychological Well-Being Scale (42-item) PRE
Description
Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Ryff's Psychological Well-Being Scale (42-item) POST
Description
Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Ryff's Psychological Well-Being Scale (42-item) RET
Description
Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294, being 42 the worst score. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
The SF-36 Health Questionnaire PRE
Description
The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
The SF-36 Health Questionnaire POST
Description
The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
The SF-36 Health Questionnaire RET
Description
The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Blood pressure PRE
Description
Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Blood pressure POST
Description
Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Blood pressure RET
Description
Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Heart rate PRE
Description
Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Heart rate POST
Description
Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Heart rate RET
Description
Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Weight PRE
Description
Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Weight POST
Description
Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Weight RET
Description
Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Height PRE
Description
Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Height POST
Description
Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Height RET
Description
Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Waist circumference PRE
Description
Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Waist circumference POST
Description
Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Waist circumference RET
Description
Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Fat mass PRE
Description
Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Fat mass POST
Description
Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Fat mass RET
Description
Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Sociodemographic characteristics questionnaire PRE
Description
Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Sociodemographic characteristics questionnaire POST
Description
Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Sociodemographic characteristics questionnaire RET
Description
Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Food Frequency Questionnaire (FFQ) PRE
Description
food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Food Frequency Questionnaire (FFQ) POST
Description
food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Food Frequency Questionnaire (FFQ) RET
Description
food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
Sleep time PRE
Description
Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
Sleep time POST
Description
Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
Sleep time RET
Description
Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23
Title
The Pittsburg Sleep Quality Index PRE
Description
The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured before the intervention program.
Time Frame
month 11-12
Title
The Pittsburg Sleep Quality Index POST
Description
The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured immediately after the intervention program.
Time Frame
month 18-19
Title
The Pittsburg Sleep Quality Index RET
Description
The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured 4 weeks after the intervention program.
Time Frame
month 22-23

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female participants between 25-65 years. Mild and / or moderate depression diagnosed by Beck Scale. Do not have other severe somatic or psychiatric disorders or other diseases that prevents physical activity. To be able to communicate with any problem. To be able to read and understand the main purpose of the study. Informed consent: must be capable and willing to provide consent. Exclusion Criteria: Major depression diagnosed. Acute or terminal illness. History of cerebral infarction, epilepsy, brain tumor. Unstable cardiovascular disease, or other medical conditions. Upper or lower extremity fracture in the past 3 months. Severe visual or auditory problems. Unwillingness to either complete the study requirements or to be randomized into control or training group. To be a participant in another research study that may influence the present project.
Facility Information:
Facility Name
University of Cádiz
City
Puerto Real
State/Province
Cádiz
ZIP/Postal Code
11510
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Internet-based Physical Activities Randomized Controlled Trial in Mild/Moderate Depression Participants: SONRIE Project

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