Exercise ProgramNCT04480606
Evaluation of the Physical Activity Level of the Elderly in Social Isolation
A study testing Home exercise program in people with Exercise Program, run by Istinye University.
Trial summary
Due to the COVID-19 pandemic in our country, individuals over 65 are prohibited from leaving their homes by T.C. The Ministry of Internal Affairs on March 21, 2020. While social isolation provides protection from COVID-19, it also brings some side effects that pose health risks. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Program
- What is being tested?
- Home exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 20 Nov 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being 65 years old and over
- Being in social isolation due to coronavirus epidemic
- Spending at least 1 week at home different from routine life
- Not to be obstructed from doing physical activities
- To have access to online exercise training
Who cannot join
- Having serious cognitive impairment (Mini-mental state examination being lower than 24)
- Having serious hearing and vision problems
- Having vestibular disorders that can cause loss of balance
- having serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker)
About this study
Official title: Effects of Home Exercise Program Applied to the Socially Isolated Elderly Due to COVID-19 on Physical Activity Level, Functional Capacity and Quality of Life
Due to the COVID-19 pandemic in our country, individuals over 65 are prohibited from leaving their homes by T.C. The Ministry of Internal Affairs on March 21, 2020. While social isolation provides protection from COVID-19, it also brings some side effects that pose health risks. Studies investigating the relationship between social isolation and health behavior report that individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. The effects of social isolation are related to physical inactivity, smoking.
Physical activity is any body movement produced by the contraction of skeletal muscles that increases energy consumption. 150 minutes of moderate PA, 75 minutes of severe PA per week, or combined moderate and severe intensity PA plus twice a week strength training is recommended for elderly. The prevalence of physical inactivity increases significantly with increasing age. At the global level, approximately 45% of people over the age of 60 do not meet the recommended level of PA. The decrease in physical performance is associated with the risk of falling, sarcopenia, fragility, decreased quality of life, emotionalization, comorbidity, early death, and increased health care costs.
The purpose of this study; to evaluate the physical activity level, functional capacity and quality of life of individuals over the age of 65 who socially isolated due to the precautions COVID-19 pandemic, and to investigate the effectiveness of video based home exercise program.
Read the detailed description
94 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in the study. Participants will be divided into 2 groups of 47 people. 47 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in home exercise group. A video exercise protocol was created and each exercise session was planned as daily 30 minutes for 6 weeks. Individuals will ask to do their exercises. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The exercise protocol was additionally determined as a combination of aerobic, balance and strengthening exercises. The exercise program consists of 3 levels and individuals will be provided to start at a level appropriate to their level of physical activity. The control group will be asked to remain isolated as they are and the exercise program will not be implemented.
Evaluation methods will be applied before starting the exercise program and at the end of 6 weeks.
- Conditions
- Exercise Program
- Being tested
- Home exercise program
- Keywords
- elderly, COVID 19, physical activity
- Medical subject headings
- COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exercise programBehavioural
47 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in home exercise group. A video exercise protocol was created and each exercise session was planned as daily 30 minutes for 6 weeks. Individuals will ask to do their exercises. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The exercise protocol was additionally determined as a combination of aerobic, balance and strengthening exercises. The exercise program consists of 3 levels and individuals will be provided to start at a level appropriate to their level of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Home exercise group | Experimental | 47 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in home exercise group. Receives: Behavioral: Home exercise program |
| Control Group | No intervention | The control group will be asked to remain isolated as they are and the exercise program will not be implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Scale for the Elderly
Physical Activity Scale for the Elderly will use to assess the physical activity level of elderly individuals, the factors affecting the activity level, the relationship between physical activity and health profile. The minimum and maximum score that can be obtained from the scale is 0 and 400.The higher score indicates better level of physical activity.
Measured: 6 weeks
Nottingham Health Profile
Nottingham Health Profile will use to assess the quality of life related to health. It is a general quality of life questionnaire that assesses the level of individuals' health problems and how they affect their daily life activities. It have six subtitles, scored between 0-100. The high total score indicates that the health condition is bad.
Measured: 6 weeks
Short Physical Performance Battery
Short Physical Performance Battery will use to assess physical performance. This test consists of 3 objective tests that evaluate lower body function; 4 meters walking, getting up from the chair and standing balance test. 5-step (0-4) summary score is assigned for each test; higher scores show better physical performance.
Measured: 6 weeks
Secondary outcomes (3)
Beck anxiety inventory
Beck anxiety inventory will use to assess anxiety level. The survey includes substances that determine anxious temperament, autonomic hyperactivity and motor tension, some cognitions. The patient is asked to evaluate the symptoms within the 'last week including today'. Each symptom is evaluated as none, mild, moderate, and severe. The total score ranges from 0-63.
Measured: 6 weeks
Beck depression inventory
Beck depression inventory will use to assess depression level. It consists of 21 items with an increasing score between 0-3. The total score ranges from 0-63.
Measured: 6 weeks
Contentment With Life Scale
Contentment With Life Scale will use to assess satisfaction level. The questionnaire consists of 5 questions in total and each question has a threshold of evaluation from 5 to 25 points (5 points for the worst and 25 points for the best).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion20 Nov 2020 (estimated)
- Study completion20 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise ProgramStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480606
- Sponsor's protocol ID
- 008
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home Exercise Program Applied to the Socially Isolated Elderly Due to COVID-19 on Physical Activity Level, Functional Capacity and Quality of Life
- ClinicalTrials.gov ID
- NCT04480606
- Acronym / sponsor ID
- 008
- Conditions
- Exercise Program
- Keywords
- elderly, COVID 19, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 20 Nov 2020 (estimated)
- Study completion
- 20 Nov 2020 (estimated)
- First posted
- 21 Jul 2020 (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.
Due to the COVID-19 pandemic in our country, individuals over 65 are prohibited from leaving their homes by T.C. The Ministry of Internal Affairs on March 21, 2020. While social isolation provides protection from COVID-19, it also brings some side effects that pose health risks. Studies investigating the relationship between social isolation and health behavior report that individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. The effects of social isolation are related to physical inactivity, smoking.
Physical activity is any body movement produced by the contraction of skeletal muscles that increases energy consumption. 150 minutes of moderate PA, 75 minutes of severe PA per week, or combined moderate and severe intensity PA plus twice a week strength training is recommended for elderly. The prevalence of physical inactivity increases significantly with increasing age. At the global level, approximately 45% of people over the age of 60 do not meet the recommended level of PA. The decrease in physical performance is associated with the risk of falling, sarcopenia, fragility, decreased quality of life, emotionalization, comorbidity, early death, and increased health care costs.
The purpose of this study; to evaluate the physical activity level, functional capacity and quality of life of individuals over the age of 65 who socially isolated due to the precautions COVID-19 pandemic, and to investigate the effectiveness of video based home exercise program.
Detailed description
94 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in the study. Participants will be divided into 2 groups of 47 people. 47 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in home exercise group. A video exercise protocol was created and each exercise session was planned as daily 30 minutes for 6 weeks. Individuals will ask to do their exercises. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The exercise protocol was additionally determined as a combination of aerobic, balance and strengthening exercises. The exercise program consists of 3 levels and individuals will be provided to start at a level appropriate to their level of physical activity. The control group will be asked to remain isolated as they are and the exercise program will not be implemented.
Evaluation methods will be applied before starting the exercise program and at the end of 6 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home exercise group | Experimental | Behavioral: Home exercise program47 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in home exercise group. |
| Control Group | No intervention | –The control group will be asked to remain isolated as they are and the exercise program will not be implemented. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Being 65 years old and over
- Being in social isolation due to coronavirus epidemic
- Spending at least 1 week at home different from routine life
- Not to be obstructed from doing physical activities
- To have access to online exercise training
Key exclusion criteria (4 listed)
- Having serious cognitive impairment (Mini-mental state examination being lower than 24)
- Having serious hearing and vision problems
- Having vestibular disorders that can cause loss of balance
- having serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker)
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 |
|---|---|---|
| Home exercise program47 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in home exercise group. A video exercise protocol was created and each exercise session was planned as daily 30 minutes for 6 weeks. Individuals will ask to do their exercises. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The exercise protocol was additionally determined as a combination of aerobic, balance and strengthening exercises. The exercise program consists of 3 levels and individuals will be provided to start at a level appropriate to their level of physical activity. | Behavioural | Home exercise group |
Primary outcome
Physical Activity Scale for the Elderly
Time frame: 6 weeks
Physical Activity Scale for the Elderly will use to assess the physical activity level of elderly individuals, the factors affecting the activity level, the relationship between physical activity and health profile. The minimum and maximum score that can be obtained from the scale is 0 and 400.The higher score indicates better level of physical activity.
Nottingham Health Profile
Time frame: 6 weeks
Nottingham Health Profile will use to assess the quality of life related to health. It is a general quality of life questionnaire that assesses the level of individuals' health problems and how they affect their daily life activities. It have six subtitles, scored between 0-100. The high total score indicates that the health condition is bad.
Short Physical Performance Battery
Time frame: 6 weeks
Short Physical Performance Battery will use to assess physical performance. This test consists of 3 objective tests that evaluate lower body function; 4 meters walking, getting up from the chair and standing balance test. 5-step (0-4) summary score is assigned for each test; higher scores show better physical performance.
3 secondary outcomes
Beck anxiety inventory
Time frame: 6 weeks
Beck depression inventory
Time frame: 6 weeks
Contentment With Life Scale
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise program in people with Exercise Program, run by Istinye University.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Physical Activity Scale for the Elderly (time frame: 6 weeks). The study lists 3 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 21 Jul 2020.