Physical InactivityNCT05249764
Home-Based Exercise Training in Older Adults During the COVID-19 Pandemic
A study testing Supervised Home Based Exercise Training and Unsupervised stretching and breathing exercises in people with Physical Inactivity and Aging, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Aging, COVID-19 Pandemic
- What is being tested?
- Supervised Home Based Exercise Training and Unsupervised stretching and breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2022to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Home-Based Exercise Training on Physical Fitness and Functionality in Sedentary Older Adults During the COVID-19 Pandemic
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.
Read the 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.
- Conditions
- Physical Inactivity, Aging, COVID-19 Pandemic
- Being tested
- Supervised Home Based Exercise Training, Unsupervised stretching and breathing exercises
- Keywords
- Exercise, Physical Fitness, Functionality, Older adults
- Medical subject headings
- Sedentary Behavior, COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Home Based Exercise TrainingOther
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.
Unsupervised stretching and breathing exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | 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. Receives: Other: Supervised Home Based Exercise Training |
| Control | Active comparator | 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. Receives: Other: Unsupervised stretching and breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the program and after eight weeks program
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.
Measured: Before the program and after eight weeks program
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.
Measured: Before the program and after eight weeks program
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.
Measured: Before the program and after eight weeks program
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.
Measured: Before the program and after eight weeks program
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.
Measured: Before the program and after eight weeks program
Secondary outcomes (3)
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.
Measured: Before the program and after eight weeks program
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.
Measured: Before the program and after eight weeks program
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.
Measured: Before the program and after eight weeks program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start5 Jan 2022
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Yuruk, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249764
- Sponsor's protocol ID
- KA2020/116
- Status last verified
- Apr 2022
- First submitted
- 17 Feb 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-Based Exercise Training on Physical Fitness and Functionality in Sedentary Older Adults During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05249764
- Acronym / sponsor ID
- KA2020/116
- Conditions
- Physical Inactivity, Aging, COVID-19 Pandemic
- Keywords
- Exercise, Physical Fitness, Functionality, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Other: Supervised Home Based Exercise TrainingExercise 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. |
| Control | Active comparator | Other: Unsupervised stretching and breathing exercisesIndividuals 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Home Based Exercise TrainingExercise 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. | Other | Exercise |
| Unsupervised stretching and breathing exercisesIndividuals 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. | Other | Control |
Primary outcome
Change from baseline lower extremitu muscle strength at 8 weeks
Time frame: Before the program and after eight weeks program
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
Time frame: Before the program and after eight weeks program
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
Time frame: Before the program and after eight weeks program
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
Time frame: Before the program and after eight weeks program
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
Time frame: Before the program and after eight weeks program
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
Time frame: Before the program and after eight weeks program
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.
3 secondary outcomes
Change from baseline Berg Balance Scale at 8 weeks
Time frame: Before the program and after eight weeks program
Change from baseline Timed up and go test at 8 weeks
Time frame: Before the program and after eight weeks program
Change from baseline Tinetti Fall Efficancy Scale at 8 weeks
Time frame: Before the program and after eight weeks program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Home Based Exercise Training and Unsupervised stretching and breathing exercises in people with Physical Inactivity and Aging, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline lower extremitu muscle strength at 8 weeks (time frame: Before the program and after eight weeks program). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.