Back to resultsHome-Based Exercise Training in Older Adults During the COVID-19 Pandemic
Primary Purpose
Physical Inactivity, Aging, COVID-19 Pandemic
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supervised Home Based Exercise Training
Unsupervised stretching and breathing exercises
Sponsored by
About this trial
This is an interventional treatment trial for Physical Inactivity focused on measuring Exercise, Physical Fitness, Functionality, Older adults
Eligibility Criteria
Inclusion Criteria:
- Individuals aged between 65-85 years
- Individuals have 24 points and above from the Standardized Mini-Mental State Examination
- Sedentary individuals whose physical activity levels are inactive or minimally active group according to the Short form of International Physical Activity Questionnaire (IPAQ-SF).
- Individuals who can stand for at least 90 seconds without assistance
- Individuals who voluntarily agree to participate in the study
- Individuals who have not suffered from COVID infection.
Exclusion Criteria:
- Individuals who have malignancy
- Individuals who are ambulatory with assistance
- Individuals who have severe vision loss
- Individuals who have a neurological disease (Stroke, Parkinson, Multiple Sclerosis)
- Individuals who had surgery in the last six months
- Individuals who have congestive heart failure
- Individuals who have received exercise training in the last six months
Sites / Locations
- Baskent University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Exercise
Control
Arm Description
Exercise program was prepared based on WHO, American College of Sports Medicine (ACSM), Geriatrics Physiotherapists Association and Otago exercise program for the exercise group. The older adults are given individual supervised exercise training in their own homes for eight weeks, 3 days a week and 45 minutes a day, by a physiotherapist according to social distance rules. This exercise training consists of a program that includes strengthening, flexibility, aerobic and balance exercises. Each exercise is started with eight repetitions and each week will be increased by two repetitions. In case of fatigue, a rest is given. Brochures are also be prepared for the exercises. Before each session, individuals performed warm-up exercises for 5 minutes. At the end of the session, individuals performed cooling exercises.
Individuals in the control group are performing stretching exercises for proximal extremity muscles for 15 minutes 3 times a week for eight weeks. The participants also perform breathing exercises for 5 minutes a day.
Outcomes
Primary Outcome Measures
Change from baseline lower extremitu muscle strength at 8 weeks
The chair stand test determines the muscle strength of the lower extremities. The older adult seat on a chair without arm support, with his/her feet on the ground and arms cross in the front of the chest. The number of full stands from the seated position perform within 30 seconds is recorded.
Change from baseline upper extremity muscle strength at 8 weeks
The arm curl test determines the upper extremity muscle strength. The older adult seat towards the dominant side on a chair without arm support. In this test, older women and men lift weights of 2.27 and 3.63 kilograms, respectively, starting with a full elbow extension with dominant arms and flexing the elbow to full flexion. The total number of lifts perform for 30 seconds is recorded.
Change from baseline aerobic endurance at 8 weeks
The 2-minute step test measures the aerobic endurance of the older adults as an alternative to the 6-minute walk test. The distance from the iliac crest to the midpoint of the patella is measured by a tape to determine the knee-stepping height. The midpoint between these two anatomical structures is determined. The height of the determined point from the ground is measured and marked on a wall. The older adult begins stepping as quickly as possible to reach the marked height for two minutes. The total number of correct steps is recorded. If any of the steps (right or left) do not reach the target height, those steps are considered invalid.
Change from baseline lower extremity flexibility at 8 weeks
The Chair sit-and-reach test is a modified form of the sit-and-reach test, which determines the flexibility of the hamstring muscle group. The older adult sits on the front of a chair. Then they extend the right or left knee to a full extension, the heel on the floor, and ankle in a neutral position of 90 degrees. The other knee is flexed to approximately 90 degrees. Then, the older adult is asked to reach the toes of the extended limb with his/her same side upper limb. If the middle finger could not reach to the toes, the distance is recorded as a 'minus' score; if it could touch the toes, then a distance of 'zero' score is recorded; and if it could reach past the toes, then the distance is recorded as a 'plus' score.
Change from baseline upper extremity flexibility at 8 weeks
The Back scratch test evaluates the flexibility of the upper extremities. The older adult is asked to stand up and place his/her preferred hand over the same shoulder, palm down and fingers extended, and reach down the middle of the back as far as possible. Then the researcher want the older adult to place the other arm around the back of the waist with the palm up and reach up the other hand. The distance between the middle fingers of both hands is measured with a tape. If the middle fingers do not touch each other, the distance is recorded as a 'minus' score, if it reaches the other, then a 'zero' score is recorded as; and if fingers could cross each other, then 'plus' score is recorded.
Change from baseline balance and agility at 8 weeks
The 8-foot up and go test determines the dynamic balance and agility of the older adults. The older adult gets up from a chair without any arm support and walk 2.44 meters as quickly as possible; then turn around a cone (at a specified position) and come back to sit down on the chair. The time between the older adults' starting movement and sitting down on the chair is recorded in seconds.
Secondary Outcome Measures
Change from baseline Berg Balance Scale at 8 weeks
Berg Balance Scale evaluates the balance and determines fall risk in individuals. The scale assesses 14 tasks involving static and dynamic balance. Each task is given a score ranging from 0 (failed to complete the task) to 4 (performed the task independently). The scores of the 14 tasks are summed to obtain a total score ranging from 0 to 56. 0-20 points indicate balance disorder, 21-40 points indicate acceptable balance skills, 41-56 points indicate good balance.
Change from baseline Timed up and go test at 8 weeks
The TUGT includes getting up from a chair, walking, turning, standing and sitting again, and assesses independent mobility and functional ability. Before the test, the individual is asked to get up from the chair, to walk at a safe and normal speed up to the previously marked distance of 3 meters, to turn, to walk backwards, and to sit on the chair. The time elapsed during this time is recorded in seconds.
Change from baseline Tinetti Fall Efficancy Scale at 8 weeks
The Tinetti Fall Efficancy Scale assesses effectiveness and safety of individuals while performing daily activities. The scale has 10-items. These items are; going to bed and getting out of bed, sitting and getting out of a chair, bathing, dressing and undressing, lying in the closet, walking around the house, looking at the door or phone, preparing food, tidying the house, and shopping. In the scale, individuals are asked how safe they feel during these activities and they are asked to give a score between 1 and 10 (1 = safest, 10 = least safe). When all scores are added in scale, a total score between 0-100 is obtained. High scores indicate that the individual's fear of falling increases.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05249764
Brief Title
Home-Based Exercise Training in Older Adults During the COVID-19 Pandemic
Official Title
Effects of Home-Based Exercise Training on Physical Fitness and Functionality in Sedentary Older Adults During the COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The physical fitness and functionality of older adults are affected during the COVID-19 Pandemic. Regular exercise programs are effective in physical fitness and functioning in older adults. Individualized and supervised exercise programs for older adults in a safe environment can improve physical fitness and functionality. This study aims to examine the effect of home-based and exercise training on physical fitness and functionality in sedentary older adults during the COVID-19 pandemic.
Detailed Description
Purpose: This study aims to examine the effect of home-based supervised exercise programs on physical fitness and functionality in sedentary older adults during the Covid-19 pandemic.
Methods: The older adults participating in the study are divided into two groups as exercise group and the control group. Individual exercise training is applied to the exercise group for eight weeks, three days a week, and 45 minutes a day. This exercise training consists of a program that includes strengthening, flexibility, aerobic, and balance exercises. The control group is given only of stretching and breathing exercises. Individuals are evaluated using the Berg Balance Scale, Timed Up and Go Test, Senior Fitness Test, and Tinetti Falling Efficacy Scale before starting the study and at the end of the eight weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Aging, COVID-19 Pandemic
Keywords
Exercise, Physical Fitness, Functionality, Older adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants in the study and control group do not know the content of the exercise program. All groups are taking exercise programs individually at their home. So that individuals are not aware of the groups.
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Exercise program was prepared based on WHO, American College of Sports Medicine (ACSM), Geriatrics Physiotherapists Association and Otago exercise program for the exercise group. The older adults are given individual supervised exercise training in their own homes for eight weeks, 3 days a week and 45 minutes a day, by a physiotherapist according to social distance rules. This exercise training consists of a program that includes strengthening, flexibility, aerobic and balance exercises. Each exercise is started with eight repetitions and each week will be increased by two repetitions. In case of fatigue, a rest is given. Brochures are also be prepared for the exercises. Before each session, individuals performed warm-up exercises for 5 minutes. At the end of the session, individuals performed cooling exercises.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Individuals in the control group are performing stretching exercises for proximal extremity muscles for 15 minutes 3 times a week for eight weeks. The participants also perform breathing exercises for 5 minutes a day.
Intervention Type
Other
Intervention Name(s)
Supervised Home Based Exercise Training
Intervention Description
Exercise program was prepared based on WHO, American College of Sports Medicine (ACSM), Geriatrics Physiotherapists Association and Otago exercise program for the exercise group. The older adults are given individual supervised exercise training in their own homes for eight weeks, 3 days a week and 45 minutes a day, by a physiotherapist according to social distance rules. This exercise training consists of a program that includes strengthening, flexibility, aerobic and balance exercises. Each exercise is started with eight repetitions and each week will be increased by two repetitions. In case of fatigue, a rest is given. Brochures are also be prepared for the exercises. Before each session, individuals performed warm-up exercises for 5 minutes. At the end of the session, individuals performed cooling exercises.
Intervention Type
Other
Intervention Name(s)
Unsupervised stretching and breathing exercises
Intervention Description
Individuals in the control group are performing stretching exercises for proximal extremity muscles for 15 minutes 3 times a week for eight weeks. The participants also perform breathing exercises for 5 minutes a day.
Primary Outcome Measure Information:
Title
Change from baseline lower extremitu muscle strength at 8 weeks
Description
The chair stand test determines the muscle strength of the lower extremities. The older adult seat on a chair without arm support, with his/her feet on the ground and arms cross in the front of the chest. The number of full stands from the seated position perform within 30 seconds is recorded.
Time Frame
Before the program and after eight weeks program
Title
Change from baseline upper extremity muscle strength at 8 weeks
Description
The arm curl test determines the upper extremity muscle strength. The older adult seat towards the dominant side on a chair without arm support. In this test, older women and men lift weights of 2.27 and 3.63 kilograms, respectively, starting with a full elbow extension with dominant arms and flexing the elbow to full flexion. The total number of lifts perform for 30 seconds is recorded.
Time Frame
Before the program and after eight weeks program
Title
Change from baseline aerobic endurance at 8 weeks
Description
The 2-minute step test measures the aerobic endurance of the older adults as an alternative to the 6-minute walk test. The distance from the iliac crest to the midpoint of the patella is measured by a tape to determine the knee-stepping height. The midpoint between these two anatomical structures is determined. The height of the determined point from the ground is measured and marked on a wall. The older adult begins stepping as quickly as possible to reach the marked height for two minutes. The total number of correct steps is recorded. If any of the steps (right or left) do not reach the target height, those steps are considered invalid.
Time Frame
Before the program and after eight weeks program
Title
Change from baseline lower extremity flexibility at 8 weeks
Description
The Chair sit-and-reach test is a modified form of the sit-and-reach test, which determines the flexibility of the hamstring muscle group. The older adult sits on the front of a chair. Then they extend the right or left knee to a full extension, the heel on the floor, and ankle in a neutral position of 90 degrees. The other knee is flexed to approximately 90 degrees. Then, the older adult is asked to reach the toes of the extended limb with his/her same side upper limb. If the middle finger could not reach to the toes, the distance is recorded as a 'minus' score; if it could touch the toes, then a distance of 'zero' score is recorded; and if it could reach past the toes, then the distance is recorded as a 'plus' score.
Time Frame
Before the program and after eight weeks program
Title
Change from baseline upper extremity flexibility at 8 weeks
Description
The Back scratch test evaluates the flexibility of the upper extremities. The older adult is asked to stand up and place his/her preferred hand over the same shoulder, palm down and fingers extended, and reach down the middle of the back as far as possible. Then the researcher want the older adult to place the other arm around the back of the waist with the palm up and reach up the other hand. The distance between the middle fingers of both hands is measured with a tape. If the middle fingers do not touch each other, the distance is recorded as a 'minus' score, if it reaches the other, then a 'zero' score is recorded as; and if fingers could cross each other, then 'plus' score is recorded.
Time Frame
Before the program and after eight weeks program
Title
Change from baseline balance and agility at 8 weeks
Description
The 8-foot up and go test determines the dynamic balance and agility of the older adults. The older adult gets up from a chair without any arm support and walk 2.44 meters as quickly as possible; then turn around a cone (at a specified position) and come back to sit down on the chair. The time between the older adults' starting movement and sitting down on the chair is recorded in seconds.
Time Frame
Before the program and after eight weeks program
Secondary Outcome Measure Information:
Title
Change from baseline Berg Balance Scale at 8 weeks
Description
Berg Balance Scale evaluates the balance and determines fall risk in individuals. The scale assesses 14 tasks involving static and dynamic balance. Each task is given a score ranging from 0 (failed to complete the task) to 4 (performed the task independently). The scores of the 14 tasks are summed to obtain a total score ranging from 0 to 56. 0-20 points indicate balance disorder, 21-40 points indicate acceptable balance skills, 41-56 points indicate good balance.
Time Frame
Before the program and after eight weeks program
Title
Change from baseline Timed up and go test at 8 weeks
Description
The TUGT includes getting up from a chair, walking, turning, standing and sitting again, and assesses independent mobility and functional ability. Before the test, the individual is asked to get up from the chair, to walk at a safe and normal speed up to the previously marked distance of 3 meters, to turn, to walk backwards, and to sit on the chair. The time elapsed during this time is recorded in seconds.
Time Frame
Before the program and after eight weeks program
Title
Change from baseline Tinetti Fall Efficancy Scale at 8 weeks
Description
The Tinetti Fall Efficancy Scale assesses effectiveness and safety of individuals while performing daily activities. The scale has 10-items. These items are; going to bed and getting out of bed, sitting and getting out of a chair, bathing, dressing and undressing, lying in the closet, walking around the house, looking at the door or phone, preparing food, tidying the house, and shopping. In the scale, individuals are asked how safe they feel during these activities and they are asked to give a score between 1 and 10 (1 = safest, 10 = least safe). When all scores are added in scale, a total score between 0-100 is obtained. High scores indicate that the individual's fear of falling increases.
Time Frame
Before the program and after eight weeks program
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:
Individuals aged between 65-85 years
Individuals have 24 points and above from the Standardized Mini-Mental State Examination
Sedentary individuals whose physical activity levels are inactive or minimally active group according to the Short form of International Physical Activity Questionnaire (IPAQ-SF).
Individuals who can stand for at least 90 seconds without assistance
Individuals who voluntarily agree to participate in the study
Individuals who have not suffered from COVID infection.
Exclusion Criteria:
Individuals who have malignancy
Individuals who are ambulatory with assistance
Individuals who have severe vision loss
Individuals who have a neurological disease (Stroke, Parkinson, Multiple Sclerosis)
Individuals who had surgery in the last six months
Individuals who have congestive heart failure
Individuals who have received exercise training in the last six months
Facility Information:
Facility Name
Baskent University
City
Ankara
ZIP/Postal Code
06790
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Home-Based Exercise Training in Older Adults During the COVID-19 Pandemic
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