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Effects of Multidomain Training of Health With Aging (Train-Old) (Train-Old)

Primary Purpose

Sarcopenia, Memory Loss, Muscular Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multidomain training
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring older adults, Healthy aging, Resistance training, cognitive training, cardiovascular training

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subject has provided written and dated informed consent to participate in the study.
  2. Subject is a male or female between 55 and 90 years of age, inclusive.
  3. Subject is in good health as determined by a health history questionnaire and has been provided clearance from their personal physician.
  4. Subject is untrained in resistance and aerobic exercise (does not participate in structured physical activity, including walking, more than 3 times per week).
  5. Ability to walk independently without any gait aid

Exclusion Criteria:

  1. Perform high-intensity aerobic exercise on a consistent basis (>180 min-week).
  2. Be performing some other regular and systematic strength training program during the intervention in the first half of 2022.
  3. Have a body mass index greater than 35.
  4. Have a diagnosis of ischemic heart disease.
  5. Have a diagnosis of severe aortic stenosis, uncontrolled arrhythmias, decompensated heart failure or acute myocarditis.
  6. Possess uncontrolled blood pressure (TAS >180 and TAD >110).
  7. Stroke.
  8. Severe peripheral arterial disease.
  9. Other illnesses such as recent thromboembolic disease, aortic aneurysm, clinically significant renal or hepatic insufficiency, severe COPD, clinically significant acute infections, severe psychiatric illness, uncontrolled metabolic disease, limiting locomotor pathology or musculoskeletal disease worsened by exercise, hormone therapy at the time or one year prior, being a woman with surgical menopause.
  10. Other pathologies that contraindicate the practice of physical exercise, collected in the previous medical examination that all participants must undergo.

Sites / Locations

  • Pablo Jorge Marcos PardoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multidomain training group

Control group

Arm Description

Participants will use free weights and functional materials to work the main muscle groups. In addition, they will perform cardiorespiratory training and cognitive training with proposed tasks. Participants will follow the planned training progression. The researchers will record the number of sets completed and the load lifted for each exercise for each participant and the perception of effort in each class.

The control group did not receive a training program and were asked not to modify their physical activity habits.

Outcomes

Primary Outcome Measures

Body Weight in Kilograms
was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.
Height in Meters
Standing height without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm.
Body Mass Index (BMI)
was calculated as the ratio of weight to squared height in kg/m^2
% Fat Mass
% fat mass was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.
Muscle quality sarcopenia
Sarcopenia will be assessed taking into account the reference values established for muscle quality. The muscle quality will be measure by hand grip strength test. This test will be performance with manual dynamometry (TKK 5401; Scientific Instruments Co., Ltd., Tokyo, Japan). Maximal isometric upper limb strength will be performance by maximal isometric strength. Upper strength will be register by kilogrammes. Higher value show high strength.

Secondary Outcome Measures

Change Blood pressure
Blood pressure and heart rate will be assessed by means of an automatic device (Colin BP 880, Inc., Tampa, FL). This is noninvasive technique. The result will be register in millimeters of mercury (bood pressure) and number of pulse per minutes (heart rate).
Change Chair stand test
Chair stand test measure the functional capacity. This is a easy physical test. This test measures the functionality of getting up and sitting down from a chair five times. The participant have to performance the test as faster as possible. The total time is recorded in seconds. A better time indicates better functional ability.
Change Upper and Lower strength
Maximal isometric upper limb strength will be performance by maximal isometric strength of knee extension and biceps flexion with load cell. Maximal isometric lower limb will be registered in newton. Higher value show high strength.
Health-related quality
SF-36 quality of life questionnaire
Cardiorrespiratory 6 minutes walk test
cardiorespiratory endurance test that evaluates the distance covered in 6 minutes.
Change heart rate
Heart rate will be assessed by means of an automatic device (Colin BP 880, Inc., Tampa, FL). This is noninvasive technique. The result will be register in number of pulse per minutes (heart rate).
Gait speed
Gait speed will be measure by 4. 6 and 10 meter test. This is easy physical test in with the participant have to walk 4. 6 and 10 metres as faster as possible. The result will be register in seconds. Less time indicates better functional ability.
Time up and go test change
Time up and go test measure the functional capacity of getting up, walking and sitting down form a chair. Participant have to performance this test as faster as possible. This is a easy physical test. Total seconds are records. Less seconds indicates better functional ability.
Short physical performance battery (SPPB)
Short physical performance battery (SPBB) include three test (balance, chair stand test and gait speed) and report a final score. Chair stand test and gait speed were describe in other outcome. Balance test is a easy physical test. The participant must maintain three balancing positions for 10 seconds to overcome it. Each test offers a different score. Higher score show better functional capacity.
Fragility
Frailty will be defined in relation to Fried's frailty phenotype (Fried et al., 2001), based on 5 criteria: unintentional weight loss, exhaustion, weakness, slow walking speed and low physical activity.
Satisfaction with life
The Satisfaction with Life Scale is a 4-item instrument with a Likert-type scale ranging from 1 to 7 points measuring overall subjective happiness by means of statements in which participants rate themselves or compare themselves with others. Two items ask people to describe themselves using absolute rating criteria of their lives or rating criteria with respect to others, while the other two items present brief descriptions of happy or unhappy people and respondents are asked to indicate the degree to which they identify with that description.
Depression
Depression will be measured through the Center for Epidemiological Studies Depression Scale-Revised (CESD-R) (Van Dam & Earleywine, 2011), is a 20-item questionnaire that can be used to measure levels of depressive symptoms among elderly participants. The CESD-R consists of 16 items of negative affect and 4 items of positive affect.
Cognitive flexibility
the Stroop test measures the ability to classify information selectively. It consists of 3 phases and requires discerning between colors and words without making mistakes.
Attention test
the Trail Making test will also assess flexibility of thought and visuospatial ability. It consists of joining numbers and words in a numerical sequence without error.
PSQ test
To evaluate the factors that influence the general state of health, specifically stress. It evaluates six factors: Tension-Instability-Fatigue; Social Acceptance of Conflict; Energy and Fun; Overload; Satisfaction for self-fulfillment; Fear and anxiety.
TMMS-24
Trait-Meta Mood Scale (TMMS) emotional states

Full Information

First Posted
July 28, 2022
Last Updated
July 31, 2022
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT05481346
Brief Title
Effects of Multidomain Training of Health With Aging (Train-Old)
Acronym
Train-Old
Official Title
Psycho-physiological Effects of Multidomain Training in Adults and Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
September 18, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

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

5. Study Description

Brief Summary
The current study aims to determine the effect of a multidomain intervention (physical fitness, motivational and cognitive training) on body composition, sarcopenia, cardiovascular health, physical fitness, functional capacity, quality of life, frailty, emotional state and cognitive status in elderly participants, through a randomized controlled trial, to determine its suitability and recommend it as a preventive and health strategy for community-dwelling older adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Memory Loss, Muscular Atrophy, Cardiovascular Diseases, Frailty
Keywords
older adults, Healthy aging, Resistance training, cognitive training, cardiovascular training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to an experimental group that will perform the physical exercise program and a control group that will perform nothing and continue with their normal lifestyle routines, without any physical activity.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multidomain training group
Arm Type
Experimental
Arm Description
Participants will use free weights and functional materials to work the main muscle groups. In addition, they will perform cardiorespiratory training and cognitive training with proposed tasks. Participants will follow the planned training progression. The researchers will record the number of sets completed and the load lifted for each exercise for each participant and the perception of effort in each class.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group did not receive a training program and were asked not to modify their physical activity habits.
Intervention Type
Procedure
Intervention Name(s)
Multidomain training
Intervention Description
The training program has a duration of 18 weeks with 2 training sessions per week. The training will have a gradual progression of intensity. One day they train two blocks of strength and one block of cognitive exercises and on the second day, they train one block of power, one block of strength+cognitive and one block of aerobic training. All sessions are 60 minutes long (10 minutes of warm-up, 40 minutes of training and 10 minutes of cool-down). Classes are in small groups of no more than 8 members.
Primary Outcome Measure Information:
Title
Body Weight in Kilograms
Description
was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.
Time Frame
Change from Baseline body weight (kg) at 18 weeks
Title
Height in Meters
Description
Standing height without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm.
Time Frame
Change from Baseline standing height (cm) at 18 weeks
Title
Body Mass Index (BMI)
Description
was calculated as the ratio of weight to squared height in kg/m^2
Time Frame
Change from Baseline Body Mass Index (BMI): (kg/m^2) at 18 weeks
Title
% Fat Mass
Description
% fat mass was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.
Time Frame
Change from Baseline bioelectrical impedance % fat mass at 18 weeks
Title
Muscle quality sarcopenia
Description
Sarcopenia will be assessed taking into account the reference values established for muscle quality. The muscle quality will be measure by hand grip strength test. This test will be performance with manual dynamometry (TKK 5401; Scientific Instruments Co., Ltd., Tokyo, Japan). Maximal isometric upper limb strength will be performance by maximal isometric strength. Upper strength will be register by kilogrammes. Higher value show high strength.
Time Frame
Change from Baseline to 18 weeks
Secondary Outcome Measure Information:
Title
Change Blood pressure
Description
Blood pressure and heart rate will be assessed by means of an automatic device (Colin BP 880, Inc., Tampa, FL). This is noninvasive technique. The result will be register in millimeters of mercury (bood pressure) and number of pulse per minutes (heart rate).
Time Frame
Change from Baseline to 18 weeks
Title
Change Chair stand test
Description
Chair stand test measure the functional capacity. This is a easy physical test. This test measures the functionality of getting up and sitting down from a chair five times. The participant have to performance the test as faster as possible. The total time is recorded in seconds. A better time indicates better functional ability.
Time Frame
Change from Baseline to 18 weeks
Title
Change Upper and Lower strength
Description
Maximal isometric upper limb strength will be performance by maximal isometric strength of knee extension and biceps flexion with load cell. Maximal isometric lower limb will be registered in newton. Higher value show high strength.
Time Frame
Change from Baseline to 18 weeks
Title
Health-related quality
Description
SF-36 quality of life questionnaire
Time Frame
Change from Baseline to 18 weeks
Title
Cardiorrespiratory 6 minutes walk test
Description
cardiorespiratory endurance test that evaluates the distance covered in 6 minutes.
Time Frame
Change from Baseline to 18 weeks
Title
Change heart rate
Description
Heart rate will be assessed by means of an automatic device (Colin BP 880, Inc., Tampa, FL). This is noninvasive technique. The result will be register in number of pulse per minutes (heart rate).
Time Frame
Change from Baseline to 18 weeks
Title
Gait speed
Description
Gait speed will be measure by 4. 6 and 10 meter test. This is easy physical test in with the participant have to walk 4. 6 and 10 metres as faster as possible. The result will be register in seconds. Less time indicates better functional ability.
Time Frame
Change from Baseline to 18 weeks
Title
Time up and go test change
Description
Time up and go test measure the functional capacity of getting up, walking and sitting down form a chair. Participant have to performance this test as faster as possible. This is a easy physical test. Total seconds are records. Less seconds indicates better functional ability.
Time Frame
Change from Baseline to 18 weeks
Title
Short physical performance battery (SPPB)
Description
Short physical performance battery (SPBB) include three test (balance, chair stand test and gait speed) and report a final score. Chair stand test and gait speed were describe in other outcome. Balance test is a easy physical test. The participant must maintain three balancing positions for 10 seconds to overcome it. Each test offers a different score. Higher score show better functional capacity.
Time Frame
Change from Baseline to 18 weeks
Title
Fragility
Description
Frailty will be defined in relation to Fried's frailty phenotype (Fried et al., 2001), based on 5 criteria: unintentional weight loss, exhaustion, weakness, slow walking speed and low physical activity.
Time Frame
Change from Baseline to 18 weeks
Title
Satisfaction with life
Description
The Satisfaction with Life Scale is a 4-item instrument with a Likert-type scale ranging from 1 to 7 points measuring overall subjective happiness by means of statements in which participants rate themselves or compare themselves with others. Two items ask people to describe themselves using absolute rating criteria of their lives or rating criteria with respect to others, while the other two items present brief descriptions of happy or unhappy people and respondents are asked to indicate the degree to which they identify with that description.
Time Frame
Change from Baseline to 18 weeks
Title
Depression
Description
Depression will be measured through the Center for Epidemiological Studies Depression Scale-Revised (CESD-R) (Van Dam & Earleywine, 2011), is a 20-item questionnaire that can be used to measure levels of depressive symptoms among elderly participants. The CESD-R consists of 16 items of negative affect and 4 items of positive affect.
Time Frame
Change from Baseline to 18 weeks
Title
Cognitive flexibility
Description
the Stroop test measures the ability to classify information selectively. It consists of 3 phases and requires discerning between colors and words without making mistakes.
Time Frame
Change from Baseline to 18 weeks
Title
Attention test
Description
the Trail Making test will also assess flexibility of thought and visuospatial ability. It consists of joining numbers and words in a numerical sequence without error.
Time Frame
Change from Baseline to 18 weeks
Title
PSQ test
Description
To evaluate the factors that influence the general state of health, specifically stress. It evaluates six factors: Tension-Instability-Fatigue; Social Acceptance of Conflict; Energy and Fun; Overload; Satisfaction for self-fulfillment; Fear and anxiety.
Time Frame
Change from Baseline to 18 weeks
Title
TMMS-24
Description
Trait-Meta Mood Scale (TMMS) emotional states
Time Frame
Change from Baseline to 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject has provided written and dated informed consent to participate in the study. Subject is a male or female between 55 and 90 years of age, inclusive. Subject is in good health as determined by a health history questionnaire and has been provided clearance from their personal physician. Subject is untrained in resistance and aerobic exercise (does not participate in structured physical activity, including walking, more than 3 times per week). Ability to walk independently without any gait aid Exclusion Criteria: Perform high-intensity aerobic exercise on a consistent basis (>180 min-week). Be performing some other regular and systematic strength training program during the intervention in the first half of 2022. Have a body mass index greater than 35. Have a diagnosis of ischemic heart disease. Have a diagnosis of severe aortic stenosis, uncontrolled arrhythmias, decompensated heart failure or acute myocarditis. Possess uncontrolled blood pressure (TAS >180 and TAD >110). Stroke. Severe peripheral arterial disease. Other illnesses such as recent thromboembolic disease, aortic aneurysm, clinically significant renal or hepatic insufficiency, severe COPD, clinically significant acute infections, severe psychiatric illness, uncontrolled metabolic disease, limiting locomotor pathology or musculoskeletal disease worsened by exercise, hormone therapy at the time or one year prior, being a woman with surgical menopause. Other pathologies that contraindicate the practice of physical exercise, collected in the previous medical examination that all participants must undergo.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Jorge Marcos Pardo, PhD
Phone
+34 950214791
Email
pjmarcos@ual.es
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Jorge Marcos Pardo, PhD
Phone
+34 950214791
Email
pablomarcospardo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Jorge Marcos Pardo, PhD
Organizational Affiliation
Universidad de Almeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pablo Jorge Marcos Pardo
City
Almería
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Jorge Marcos Pardo, PhD
Email
pjmarcos@ual.es
First Name & Middle Initial & Last Name & Degree
Antonio Jesús Casimiro Andújar, PhD
Email
casimiro@ual.es
First Name & Middle Initial & Last Name & Degree
Pablo Jorge Marcos Pardo, Phd
First Name & Middle Initial & Last Name & Degree
Antonio Jesús Casimiro Andújar, PhD
First Name & Middle Initial & Last Name & Degree
Antonio Manuel García Llorente, PhD student

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Once the data are published, the data can be requested and will be made available to other researchers.

Learn more about this trial

Effects of Multidomain Training of Health With Aging (Train-Old)

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