- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04335851
Video-Based Exercises and Well-Being During Social Isolation
June 4, 2020 updated by: Begum Kara Kaya, Biruni University
Effectiveness of Video-Based Exercises on Physical and Emotional Well-Being During COVID-19 Induced Social Isolation
Both influenza and coronaviruses cause respiratory infections, which can lead to morbidity and mortality, especially in those who are immunocompromised or not immune to viruses (Zhu).
Physical exercise has many effects on the human body, including the immune system.
Moderate exercise appears to have a beneficial effect on immune function, which can protect against upper respiratory infections.
Human being is a social entity by nature and social isolation can negatively affect individuals' psychology.
There are many studies examining the effect of physical activity on the mental state of people.
The World Health Organization (WHO) suggests individual protection measures such as establishing necessary hygienic conditions, ensuring social isolation and keeping immune system strong against the complications that may develop due to Coronavirus.Human being is a social entity by nature and social isolation can negatively affect individuals' psychology.
There are many studies examining the effect of physical activity on the mental state of people.
Different theories which claims the psychological improvements resulting from the increased levels of physical activity have also been proposed in the literature.Regular aerobic exercise and walking can not only improve the emotional state of the individuals, but may also affect the mental health by avoiding the negative thoughts and adapting to stress.
The aim of this study is to increase the physical activity level, psychological condition and physical well-being with video-based exercises.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) is a new form of coronaviruses that emerged in 2019 and causes Coronavirus Disease 2019 (COVID-19).
SARS-CoV-2 is highly contagious.
The World Health Organization (WHO) suggests individual protection measures such as establishing necessary hygienic conditions, ensuring social isolation and keeping immune system strong against the complications that may develop due to Coronavirus.
Both influenza and coronaviruses cause respiratory infections, which can lead to morbidity and mortality, especially in those who are immunocompromised or not immune to viruses (Zhu).
Physical exercise has many effects on the human body, including the immune system.
Moderate exercise appears to have a beneficial effect on immune function, which can protect against upper respiratory infections.
Human being is a social entity by nature and social isolation can negatively affect individuals' psychology.
There are many studies examining the effect of physical activity on the mental state of people.
Different theories which claims the psychological improvements resulting from the increased levels of physical activity have also been proposed in the literature.Human being is a social entity by nature and social isolation can negatively affect individuals' psychology.
There are many studies examining the effect of physical activity on the mental state of people.
Different theories which claims the psychological improvements resulting from the increased levels of physical activity have also been proposed in the literature.Regular aerobic exercise and walking can not only improve the emotional state of the individuals, but may also affect the mental health by avoiding the negative thoughts and adapting to stress.
The aim of this study is to increase the physical activity level, psychological condition and physical well-being with video-based exercises.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Biruni University
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Istanbul, Turkey
- Istanbul University Cerrahpasa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- who haven't been exercising before and also not thinking of exercising during the isolation period
- Who are willing to exercise during the isolation
Exclusion Criteria:
- Having a disease that may interfere or aggravated with exercise such as orthopaedic problems, chronic diseases, etc.
- Having difficulty of understanding and following video-based exercises
- Having diagnose of any kind of psychiatric condition such as major depression, panic attack, etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical Activity Group
Individuals in this group will be given "walk at home" exercise video made by American Hearth Association.
Videos for each week will be chosen by therapist.
They will be asked to do exercise 3 days a week for 4 weeks by following the videos.
The intensity and duration of the exercises will be gradually increased by therapists each week.
Exercise follow-ups will be done over the phone and by asking individuals to keep an exercise diary.
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During social isolation induced by COVID-19, physically inactive people will do exercise in company with aerobic exercises named videos"walk at home" which made by American Heart Association.
3 days a week in total 4 weeks.
Each sessions will last approximately 30-40 minutes.
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No Intervention: Control Group
Physically inactive individuals will be included to study as control.
Individuals will be asked to continue their daily routines.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
World Health Organization Quality of Life Questionnaire Bref
Time Frame: 2 months
|
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
Turkish version of WHOQoL- BREF will be used in the study.The WHOQOL-BREF produces a quality of life profile.
It is possible to derive four domain scores.
There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life and question 2 asks about an individual's overall perception of their health.
The four domain scores denote an individual's perception of quality of life in each particular domain.
Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
The mean score of items within each domain is used to calculate the domain score.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rapid Assessment of Physical Activity
Time Frame: 2 months
|
Rapid Assessment of Physical Activity (RAPA) is an easy-to-use form which assesses both aerobic and strength & flexibility exercise levels.
Turkish version of RAPA will be used in the study.
The RAPA questionnaire is based on a scale of 1-7 measuring the amount and intensity and duration of physical activity that a person does.
A score of 5 or below signifies sub-optimal physical activity and that of 6 or above signifies optimal physical activity.
The activities are divided into light, moderate and vigorous activities.
|
2 months
|
Global Rating of Change Scale
Time Frame: 2 months
|
The effectiveness of the exercise will also be evaluated with the Global Rating of Change scale (GRC).
GRC scales have short administration time, applicability to nearly all patient and healthy group.
In the study -point scale will be used.
It is ranging from -2 (very much worse), through 0 (unchanged) to +2 (much better).
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Begum Kara Kaya, MSc, Biruni University
- Study Chair: Ayşe Zengin Alpözgen, Assistant Professor, PhD, Istanbul University - Cerrahpasa (IUC)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2020
Primary Completion (Actual)
May 15, 2020
Study Completion (Actual)
June 3, 2020
Study Registration Dates
First Submitted
April 2, 2020
First Submitted That Met QC Criteria
April 3, 2020
First Posted (Actual)
April 6, 2020
Study Record Updates
Last Update Posted (Actual)
June 9, 2020
Last Update Submitted That Met QC Criteria
June 4, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Physical Activity Project
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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