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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Istanbul, Turkey
        • Biruni University
      • Istanbul, Turkey
        • İstanbul University Cerrahpaşa

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Video based aerobic exercise
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.
No Intervention: Control Group
Physically inactive individuals will be included to study as control. Individuals will be asked to continue their daily routines.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biruni University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul University - Cerrahpasa (IUC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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