Back to resultsThe Effects of Green Exercise Program Consisting of 12-week Aerobic and Resistance Exercises on Sleep Quality, Alexithymia, Anxiety and Depression in Elderly People
Primary Purpose
Elderly, Exercise
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
both aerobic and resistance exercises in the green exercise concept
Sponsored by
About this trial
This is an interventional treatment trial for Elderly focused on measuring elderly, exercise, Affective Symptoms, anxiety, depression
Eligibility Criteria
Inclusion Criteria:
- people aged over 65 years
- Be fit to participate in exercise program after the first cardiac examination by the physician
- Having a score above 24 in the Minimental Test
Exclusion Criteria:
- Having neuromuscular disease
- Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
- Having an orthopedic disease that interferes with walking
- Having a score below 24 in the Minimental Test
Sites / Locations
- Istanbul Medeniyet UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Both aerobic and resistance exercises in the green exercise concept
Control group
Arm Description
Green exercise is a type of exercise done outdoors. It is an advantageous type of exercise in benefiting from sunlight and reducing anxiety. Participants in this group will be given aerobic and resistance exercises in the open air. For 20 participants who met the inclusion criteria, first 10 minutes of warm-up exercises, then 20 minutes of moderate-intensity (65% of heart rate) walking, followed by 15 minutes of low-intensity (50% of the maximum repetitions) resistance exercises will be trained in the presence of a physiotherapist. resistance exercises will be performed for shoulder flexors and abductors, elbow flexors and extensors, hip flexors and extensors, knee flexors and extensors, hip abductor muscle groups. At the end of each session, 5 minutes of stretching exercises will also be trained.
The exercise program will not be implemented. Evaluations will be made at the beginning and end of the study.
Outcomes
Primary Outcome Measures
Sleep quality
Sleep quality will be evaulated with Pittsburg Sleep Quality Index (PUKI). PUKI was developed by Buysee et al. in 1989 and provides a quantitative measure of sleep quality. It contains a total of 24 questions. Each item is scored between 0-3 points. It has 7 components (subjective sleep quality, sleep duration, sleep disturbance, sleep latency, habitual sleep efficiency, sleep medication use, daytime dysfunction). The sum of the scores of these seven components gives the total index score. High scores indicate poor sleep quality.
Anxiety
Anxiety will be evaluated with Geriatric Anxiety Scale. It is a self-filled scale developed for the elderly, observing anxiety symptoms, having somatic, cognitive and affective subscales. It is a 4-point Likert scale scored between 0-3 and consists of 30 questions in total. Items between 24 and 28 are not included in the total score, clinicians use these items to determine the domain of anxiety. The total score ranges from 0 to 75. A high score indicates a high level of anxiety.
Depression
Depression will be assessed with the Geriatric Depression Scale. GDS is a self-reported scale consisting of 30 questions and asked to be answered in a yes/no format. In scoring the scale, 1 point is given for each answer in favor of depression, 0 point is given for the other answer, and the total score is accepted as the depression score. The scores that can be obtained from the scale are between 0-30.
Alexithymia
Alexithymia, also called emotional deafness, is a psychopathology characterized by difficulties in understanding, defining and expressing their own emotions. Alexithymia will be evaulated Toronto Alexithymia Scale-20. It is a Likert-type scale scored between 1 and 5, and includes 20 questions in total. Items 4,5,10,18 and 19 are reverse scored. Those with a total score of 61 and above are considered to have alexithymia.
Secondary Outcome Measures
Full Information
NCT ID
NCT05280249
First Posted
March 7, 2022
Last Updated
August 23, 2022
Sponsor
Istanbul Medeniyet University
1. Study Identification
Unique Protocol Identification Number
NCT05280249
Brief Title
The Effects of Green Exercise Program Consisting of 12-week Aerobic and Resistance Exercises on Sleep Quality, Alexithymia, Anxiety and Depression in Elderly People
Official Title
The Effects of Green Exercise Program Consisting of 12-week Aerobic and Resistance Exercises on Sleep Quality, Alexithymia, Anxiety and Depression in Elderly People
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
September 12, 2022 (Anticipated)
Study Completion Date
October 17, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
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 aim of this study is to investigate the effects of combination of aerobic and resistance exercises in the green exercise concept on depression, anxiety, alexithymia and sleep quality of elderly individuals. Elderly individuals over the age of 65 will be included in the study. Two groups of 20 people each will take part in the study. One group will be given aerobic and resistance exercises for 12 weeks, 2 days a week in the green exercise concept, the other group will be the control group and will not be included in the exercise program. Participants will be evaluated twice, at the beginning of the study and at the end of 12 weeks.
Detailed Description
Forty volunteer participants aged 65 years over will be included in the study. Participants will be randomly divided into two groups as experimental and control group. While experimental group will receive both aerobic and resistance exercises and control group will receive no exercise. Exercises will be held in an open and green area. Depression, anxiety, alexithymia and sleep quality of elderly individuals will be evaulated at the beginning of the treatment and at the end of the twelfth week. The exercise program will be done for 12 weeks, 2 days a week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Exercise
Keywords
elderly, exercise, Affective Symptoms, anxiety, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Parallel Assignment Randomized
Masking
Outcomes Assessor
Masking Description
Evaluations will be made by an impartial researcher who was not involved in the study.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Both aerobic and resistance exercises in the green exercise concept
Arm Type
Experimental
Arm Description
Green exercise is a type of exercise done outdoors. It is an advantageous type of exercise in benefiting from sunlight and reducing anxiety. Participants in this group will be given aerobic and resistance exercises in the open air. For 20 participants who met the inclusion criteria, first 10 minutes of warm-up exercises, then 20 minutes of moderate-intensity (65% of heart rate) walking, followed by 15 minutes of low-intensity (50% of the maximum repetitions) resistance exercises will be trained in the presence of a physiotherapist. resistance exercises will be performed for shoulder flexors and abductors, elbow flexors and extensors, hip flexors and extensors, knee flexors and extensors, hip abductor muscle groups. At the end of each session, 5 minutes of stretching exercises will also be trained.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The exercise program will not be implemented. Evaluations will be made at the beginning and end of the study.
Intervention Type
Other
Intervention Name(s)
both aerobic and resistance exercises in the green exercise concept
Intervention Description
Green exercise is a type of exercise done outdoors. It is an advantageous type of exercise in benefiting from sunlight and reducing anxiety. Participants in this group will be given aerobic and resistance exercises in the open air.
Primary Outcome Measure Information:
Title
Sleep quality
Description
Sleep quality will be evaulated with Pittsburg Sleep Quality Index (PUKI). PUKI was developed by Buysee et al. in 1989 and provides a quantitative measure of sleep quality. It contains a total of 24 questions. Each item is scored between 0-3 points. It has 7 components (subjective sleep quality, sleep duration, sleep disturbance, sleep latency, habitual sleep efficiency, sleep medication use, daytime dysfunction). The sum of the scores of these seven components gives the total index score. High scores indicate poor sleep quality.
Time Frame
Change from baseline sleep quality at week 12.
Title
Anxiety
Description
Anxiety will be evaluated with Geriatric Anxiety Scale. It is a self-filled scale developed for the elderly, observing anxiety symptoms, having somatic, cognitive and affective subscales. It is a 4-point Likert scale scored between 0-3 and consists of 30 questions in total. Items between 24 and 28 are not included in the total score, clinicians use these items to determine the domain of anxiety. The total score ranges from 0 to 75. A high score indicates a high level of anxiety.
Time Frame
Change from baseline anxiety level at week 12.
Title
Depression
Description
Depression will be assessed with the Geriatric Depression Scale. GDS is a self-reported scale consisting of 30 questions and asked to be answered in a yes/no format. In scoring the scale, 1 point is given for each answer in favor of depression, 0 point is given for the other answer, and the total score is accepted as the depression score. The scores that can be obtained from the scale are between 0-30.
Time Frame
Change from baseline depression level at week 12.
Title
Alexithymia
Description
Alexithymia, also called emotional deafness, is a psychopathology characterized by difficulties in understanding, defining and expressing their own emotions. Alexithymia will be evaulated Toronto Alexithymia Scale-20. It is a Likert-type scale scored between 1 and 5, and includes 20 questions in total. Items 4,5,10,18 and 19 are reverse scored. Those with a total score of 61 and above are considered to have alexithymia.
Time Frame
Change from baseline alexithymia level at week 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
people aged over 65 years
Be fit to participate in exercise program after the first cardiac examination by the physician
Having a score above 24 in the Minimental Test
Exclusion Criteria:
Having neuromuscular disease
Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
Having an orthopedic disease that interferes with walking
Having a score below 24 in the Minimental Test
Facility Information:
Facility Name
Istanbul Medeniyet University
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EMEL METE
Phone
+905376096265
Email
e_emel86@hotmail.com
Ext
METE
Email
e_emel86@hotmail.com
First Name & Middle Initial & Last Name & Degree
EMEL METE
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effects of Green Exercise Program Consisting of 12-week Aerobic and Resistance Exercises on Sleep Quality, Alexithymia, Anxiety and Depression in Elderly People
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