Social IsolationNCT04335851
Video-Based Exercises and Well-Being During Social Isolation
A study testing Video based aerobic exercise in people with Social Isolation and Physical Inactivity, run by Biruni University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Physical Inactivity, Well-Being
- What is being tested?
- Video based aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 6 Apr 2020to 3 Jun 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- who haven't been exercising before and also not thinking of exercising during the isolation period
- Who are willing to exercise during the isolation
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Biruni University
Istanbul
Istanbul University Cerrahpasa
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Isolation, Physical Inactivity, Well-Being
- Being tested
- Video based aerobic exercise
- Medical subject headings
- Social Isolation, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video based aerobic exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Group | Experimental | 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. Receives: Other: Video based aerobic exercise |
| Control Group | No intervention | Physically inactive individuals will be included to study as control. Individuals will be asked to continue their daily routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life Questionnaire Bref
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.
Measured: 2 months
Secondary outcomes (2)
Rapid Assessment of Physical Activity
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.
Measured: 2 months
Global Rating of Change Scale
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).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start6 Apr 2020
- Primary completion15 May 2020
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social IsolationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Begum Kara Kaya, Biruni University
- Investigators
- Ayşe Zengin Alpözgen, Assistant Professor, PhD, Study chair, Istanbul University - CerrahpasaBegum Kara Kaya, MSc, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335851
- Sponsor's protocol ID
- Physical Activity Project
- Status last verified
- Jun 2020
- First submitted
- 2 Apr 2020
- Last updated
- 9 Jun 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Video-Based Exercises on Physical and Emotional Well-Being During COVID-19 Induced Social Isolation
- ClinicalTrials.gov ID
- NCT04335851
- Acronym / sponsor ID
- Physical Activity Project
- Conditions
- Social Isolation, Physical Inactivity, Well-Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 6 Apr 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Group | Experimental | Other: Video based aerobic exerciseIndividuals 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. |
| Control Group | No intervention | –Physically inactive individuals will be included to study as control. Individuals will be asked to continue their daily routines. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- who haven't been exercising before and also not thinking of exercising during the isolation period
- Who are willing to exercise during the isolation
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Video based aerobic exerciseDuring 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. | Other | Physical Activity Group |
Primary outcome
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 secondary outcomes
Rapid Assessment of Physical Activity
Time frame: 2 months
Global Rating of Change Scale
Time frame: 2 months
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 9 Jun 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.
Ayşe Zengin Alpözgen, Assistant Professor, PhD study chair
Istanbul University - Cerrahpasa
Begum Kara Kaya, MSc principal investigator
Biruni University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video based aerobic exercise in people with Social Isolation and Physical Inactivity, run by Biruni University at 2 sites 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 2 inclusion and 3 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
World Health Organization Quality of Life Questionnaire Bref (time frame: 2 months). 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 9 Jun 2020.