- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04480606
Evaluation of the Physical Activity Level of the Elderly in Social Isolation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home exercise group
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.
|
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.
|
|
No Intervention: Control Group
The control group will be asked to remain isolated as they are and the exercise program will not be implemented.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
|
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.
|
6 weeks
|
|
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck anxiety inventory
Time Frame: 6 weeks
|
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.
|
6 weeks
|
|
Beck depression inventory
Time Frame: 6 weeks
|
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.
|
6 weeks
|
|
Contentment With Life Scale
Time Frame: 6 weeks
|
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).
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 008 (Nahrain Medical Research Collective (NMRC))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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