ExerciseNCT06517771
Online Aerobic Exercise and Quality of Life in Non-diagnosed COVID-19 Adults
A study testing Online aerobic exercise in people with Exercise, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
During the new coronavirus-19 (COVID-19) pandemic, assessing the effects of online aerobic exercise on physical performance and health-related quality of life (HRQoL) in adults has garnered significant interest. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Online aerobic exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 15 Jul 2023
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not diagnosed with COVID-19,
- Being between 40-60 years of age,
- Having a medium level of physical activity according to the International Physical Activity Questionnaire-Short Form (IPAQ-SF),
- Not having any mental or physical problem preventing walking, running, or jumping,
- Residing in the Muş and Denizli city provinces,
- Being able to speak and understand the local language,
- Being able to understand verbal and written information given.
Who cannot join
- Having an injury/injury affecting the lower or upper extremities within the last six months,
- Participating in any exercise or strengthening training within the previous three months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muş Alparslan University
Muş, Muş and Denizli Province
About this study
Official title: Online Aerobic Exercise During the COVID-19 Era: Exploring Physical Performance and Health-related Quality of Life Changes in Non-diagnosed COVID-19 Adults
During the new coronavirus-19 (COVID-19) pandemic, assessing the effects of online aerobic exercise on physical performance and health-related quality of life (HRQoL) in adults has garnered significant interest. This study, which investigated the impact of four-week online aerobic exercise on physical performance and HRQoL in non-diagnosed COVID-19 adults, provides crucial insights. After the study was completed, the four-week online exercise program did not significantly enhance physical performance and HRQoL but increased physical activity. These findings are important for understanding the potential of online aerobic exercise. While it may not yield notable health-related benefits, it can boost physical activity in non-diagnosed COVID-19 adults.
Read the detailed description
The rapid spread of the novel coronavirus disease-19 (COVID-19) pandemic has led clinicians to new and alternative methods and led the way for various practice strategies. Telehealth applications enable health professionals to transfer information, education, and training for health consumers via the Internet and telecommunication. Telehealth applications and remote assessment applications are technology and services that can be used during the COVID-19 pandemic process. In addition, practical applications can be made with the help of telephone and video in a guideline published concerning remote health applications.
The advantages of participation in exercise programs include improvements in physical performance, aerobic endurance, self-efficacy for exercise, self-assessed health, and pain relief. The COVID-19 pandemic has induced extensive disruptions to global health systems and accelerated the shift to remotely accessible counseling and home-based rehabilitation. Implementing remotely monitored exercise interventions has the advantages of greater access and accessibility and overcoming known barriers to face-to-face supervised exercise. In the COVID-19 pandemic, tele-exercise, including remote delivery of exercises via video conferencing technology, has emerged as a means for community-based programs to maintain follow-up exercise sessions while adhering to physical distancing restrictions. A previous investigation indicated that tele-yoga exercise sessions were feasible and acceptable in older adults. Social isolation, which required attention and practice during the COVID-19 pandemic, causes significant changes that negatively affect public health and physical activity levels. In the COVID-19 pandemic, remote exercise implementation methods mainly focused on patients with chronic diseases or the older population.
People who are not regularly active and have no contraindications are recommended to start and gradually increase their physical activity level. The World Health Organization guidelines for adults indicate that aerobic and muscle-strengthening physical activity exercises are based on solid evidence. Additionally, there needs to be randomized controlled studies in the literature regarding online physical exercise during COVID-19. Therefore, it is curious to evaluate the physical activity level and physical performance in adults during the COVID-19 pandemic and how exercise interventions will affect them. In this study, we aimed to examine the effect of online exercise training on physical performance and health-related quality of life (HRQoL) in non-diagnosed COVID-19 adults during the pandemic. As a hypothesis in our study, we hypothesized that four-week online exercise training would improve physical performance and HRQoL compared to the control group.
- Conditions
- Exercise
- Being tested
- Online aerobic exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online aerobic exerciseOther
Before starting the online aerobic exercises, for general warm-up, two minutes of walking, one minute of marching, and ten repetitions of bilateral reciprocal shoulder flexion-extension, shoulder horizontal abduction-adduction, and unilateral shoulder flexion and circling exercises were performed. For the upper extremity, full elbow extension with shoulder retraction in full shoulder flexion (Exercise V), elbows 90 degrees flexion with shoulder retraction in 90 degrees abduction (Exercise U), and full elbow flexion with shoulder extension of about 30 degrees (Exercise W) were performed. Standing hip abduction-extension, elevation on tiptoe, standing-sitting from a chair with hands on shoulders, squatting, tandem walking, and standing on one leg exercises were performed in the lower extremities. Gastrocnemius, hamstring, and shoulder posterior and inferior capsule stretching exercises were conducted as cooling exercises.
| Study group | Role | What they receive |
|---|---|---|
| Online aerobic exercise group | Experimental | Participants in the online aerobic exercise group performed aerobic exercises three days a week for four weeks under the online supervision of a physiotherapist using the WhatsApp application. Receives: Other: Online aerobic exercise |
| Control group | No intervention | The control group did not engage in any aerobic or strengthening exercise training during the four weeks and were instructed to avoid strenuous physical activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level
The participants' physical activity levels were evaluated with the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ-SF is a scale developed to determine the physical activity levels of participants aged 15-65 years and aims to obtain information about the time individuals spend in vigorous, moderate-to-vigorous activities and walking. The calculation of the IPAQ-SF total score includes the sum of the duration and frequency of walking, moderately vigorous, and vigorous activity in the last week. In physical activity level classification, individuals with a physical activity score of less than 600 Metabolic equivalents of task (MET) min/week are classified as low level, individuals with physical activity between 600-3000 MET min/week are classified as medium physical activity level, and individuals with physical activity more than 3000 MET min/week are classified as high physical activity level.
Measured: Baseline, Week 4
Physical Performance
Short Physical Performance Battery (SPPB): The SPPB is calculated from three components: the ability to stand, time to complete a 3-m walk, and time to stand from a chair five times. Each part is scored out of 4, with the scores from the three tests calculated to give a total of 12 and a minimum of 0.
Single-Leg Standing Test: For the single-leg participant stands in the dominant foot with the other knee at 90 degrees. If the participant reaches 30 seconds, the time is stopped.
Four Square Step Test (FSST): For the FSST, the participant starts from a square with both feet, steps clockwise to the starting square, and returns to the starting square without stopping (start: right-back-left-front; return: back-right-front-left).
Timed Up and Go (TUG) Test: For the TUG test, the participant has to get up from the chair, walk 3 meters, walk around the line on the floor, walk back to the chair, and sit down.
Measured: Baseline, Week 4
Health-Related Quality of Life
The health-related quality of life (HRQoL) was evaluated with the Short Form-36 (SF36). SF-36 is a patient-reported questionnaire developed and used to determine HRQoL. It is a self-assessment scale with generic criteria. In this study, SF-36 physical function and general health subscales were utilized. The subscales assess health on a 0-100 scale, with 0 indicating poor health and 100 indicating good health
Measured: Baseline, Week 4
Secondary outcomes (1)
Anxiety
The Beck Anxiety Inventory (BAI) was utilized to evaluate the participants' anxiety levels. This self-report instrument comprises 21 items that assess subjective anxiety and physical symptoms, with each item scored on a Likert scale ranging from 0 to 3. The total score on the BAI can range from 0 to 63, with higher scores reflecting more severe anxiety
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Jun 2022
- Primary completion1 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Bayrak, Muş Alparslan University
- Investigators
- Gökhan Bayrak, PhD, Principal investigator, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517771
- Sponsor's protocol ID
- 51099/8-45
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not have a plan to make individual participant data available to other researchers
Publications
Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
PubMed 33239350Canton-Martinez E, Renteria I, Machado-Parra JP, Reyes RA, Moncada-Jimenez J, Johnson DK, Gonzalez OM, Del Valle AS, Jimenez-Maldonado A. A virtually supervised exercise program improved fitness and mental wellness in healthy and comorbidity older adult individuals during the COVID-19 pandemic. Front Public Health. 2024 Apr 23;12:1328518. doi: 10.3389/fpubh.2024.1328518. eCollection 2024.
PubMed 38716241D'Oliveira A, De Souza LC, Langiano E, Falese L, Diotaiuti P, Vilarino GT, Andrade A. Home Physical Exercise Protocol for Older Adults, Applied Remotely During the COVID-19 Pandemic: Protocol for Randomized and Controlled Trial. Front Psychol. 2022 Feb 4;13:828495. doi: 10.3389/fpsyg.2022.828495. eCollection 2022.
PubMed 35185739Bayrak G, Aslan UB. Four-week remotely supervised aerobic exercise during the COVID-19 era: Exploring physical performance and psychosocial health in adults without COVID-19 living in rural settings. Medicine (Baltimore). 2025 Aug 29;104(35):e44016. doi: 10.1097/MD.0000000000044016.
PubMed 40898552
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Aerobic Exercise During the COVID-19 Era: Exploring Physical Performance and Health-related Quality of Life Changes in Non-diagnosed COVID-19 Adults
- ClinicalTrials.gov ID
- NCT06517771
- Acronym / sponsor ID
- 51099/8-45
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 24 Jul 2024 (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.
During the new coronavirus-19 (COVID-19) pandemic, assessing the effects of online aerobic exercise on physical performance and health-related quality of life (HRQoL) in adults has garnered significant interest. This study, which investigated the impact of four-week online aerobic exercise on physical performance and HRQoL in non-diagnosed COVID-19 adults, provides crucial insights. After the study was completed, the four-week online exercise program did not significantly enhance physical performance and HRQoL but increased physical activity. These findings are important for understanding the potential of online aerobic exercise. While it may not yield notable health-related benefits, it can boost physical activity in non-diagnosed COVID-19 adults.
Detailed description
The rapid spread of the novel coronavirus disease-19 (COVID-19) pandemic has led clinicians to new and alternative methods and led the way for various practice strategies. Telehealth applications enable health professionals to transfer information, education, and training for health consumers via the Internet and telecommunication. Telehealth applications and remote assessment applications are technology and services that can be used during the COVID-19 pandemic process. In addition, practical applications can be made with the help of telephone and video in a guideline published concerning remote health applications.
The advantages of participation in exercise programs include improvements in physical performance, aerobic endurance, self-efficacy for exercise, self-assessed health, and pain relief. The COVID-19 pandemic has induced extensive disruptions to global health systems and accelerated the shift to remotely accessible counseling and home-based rehabilitation. Implementing remotely monitored exercise interventions has the advantages of greater access and accessibility and overcoming known barriers to face-to-face supervised exercise. In the COVID-19 pandemic, tele-exercise, including remote delivery of exercises via video conferencing technology, has emerged as a means for community-based programs to maintain follow-up exercise sessions while adhering to physical distancing restrictions. A previous investigation indicated that tele-yoga exercise sessions were feasible and acceptable in older adults. Social isolation, which required attention and practice during the COVID-19 pandemic, causes significant changes that negatively affect public health and physical activity levels. In the COVID-19 pandemic, remote exercise implementation methods mainly focused on patients with chronic diseases or the older population.
People who are not regularly active and have no contraindications are recommended to start and gradually increase their physical activity level. The World Health Organization guidelines for adults indicate that aerobic and muscle-strengthening physical activity exercises are based on solid evidence. Additionally, there needs to be randomized controlled studies in the literature regarding online physical exercise during COVID-19. Therefore, it is curious to evaluate the physical activity level and physical performance in adults during the COVID-19 pandemic and how exercise interventions will affect them. In this study, we aimed to examine the effect of online exercise training on physical performance and health-related quality of life (HRQoL) in non-diagnosed COVID-19 adults during the pandemic. As a hypothesis in our study, we hypothesized that four-week online exercise training would improve physical performance and HRQoL compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Online aerobic exercise group | Experimental | Other: Online aerobic exerciseParticipants in the online aerobic exercise group performed aerobic exercises three days a week for four weeks under the online supervision of a physiotherapist using the WhatsApp application. |
| Control group | No intervention | –The control group did not engage in any aerobic or strengthening exercise training during the four weeks and were instructed to avoid strenuous physical activities |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Not diagnosed with COVID-19,
- Being between 40-60 years of age,
- Having a medium level of physical activity according to the International Physical Activity Questionnaire-Short Form (IPAQ-SF),
- Not having any mental or physical problem preventing walking, running, or jumping,
- Residing in the Muş and Denizli city provinces,
Key exclusion criteria (2 listed)
- Having an injury/injury affecting the lower or upper extremities within the last six months,
- Participating in any exercise or strengthening training within the previous three months.
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 |
|---|---|---|
| Online aerobic exerciseBefore starting the online aerobic exercises, for general warm-up, two minutes of walking, one minute of marching, and ten repetitions of bilateral reciprocal shoulder flexion-extension, shoulder horizontal abduction-adduction, and unilateral shoulder flexion and circling exercises were performed. For the upper extremity, full elbow extension with shoulder retraction in full shoulder flexion (Exercise V), elbows 90 degrees flexion with shoulder retraction in 90 degrees abduction (Exercise U), and full elbow flexion with shoulder extension of about 30 degrees (Exercise W) were performed. Standing hip abduction-extension, elevation on tiptoe, standing-sitting from a chair with hands on shoulders, squatting, tandem walking, and standing on one leg exercises were performed in the lower extremities. Gastrocnemius, hamstring, and shoulder posterior and inferior capsule stretching exercises were conducted as cooling exercises. | Other | Online aerobic exercise group |
Primary outcome
Physical Activity Level
Time frame: Baseline, Week 4
The participants' physical activity levels were evaluated with the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ-SF is a scale developed to determine the physical activity levels of participants aged 15-65 years and aims to obtain information about the time individuals spend in vigorous, moderate-to-vigorous activities and walking. The calculation of the IPAQ-SF total score includes the sum of the duration and frequency of walking, moderately vigorous, and vigorous activity in the last week. In physical activity level classification, individuals with a physical activity score of less than 600 Metabolic equivalents of task (MET) min/week are classified as low level, individuals with physical activity between 600-3000 MET min/week are classified as medium physical activity level, and individuals with physical activity more than 3000 MET min/week are classified as high physical activity level.
Physical Performance
Time frame: Baseline, Week 4
Short Physical Performance Battery (SPPB): The SPPB is calculated from three components: the ability to stand, time to complete a 3-m walk, and time to stand from a chair five times. Each part is scored out of 4, with the scores from the three tests calculated to give a total of 12 and a minimum of 0. Single-Leg Standing Test: For the single-leg participant stands in the dominant foot with the other knee at 90 degrees. If the participant reaches 30 seconds, the time is stopped. Four Square Step Test (FSST): For the FSST, the participant starts from a square with both feet, steps clockwise to the starting square, and returns to the starting square without stopping (start: right-back-left-front; return: back-right-front-left). Timed Up and Go (TUG) Test: For the TUG test, the participant has to get up from the chair, walk 3 meters, walk around the line on the floor, walk back to the chair, and sit down.
Health-Related Quality of Life
Time frame: Baseline, Week 4
The health-related quality of life (HRQoL) was evaluated with the Short Form-36 (SF36). SF-36 is a patient-reported questionnaire developed and used to determine HRQoL. It is a self-assessment scale with generic criteria. In this study, SF-36 physical function and general health subscales were utilized. The subscales assess health on a 0-100 scale, with 0 indicating poor health and 100 indicating good health
1 secondary outcome
Anxiety
Time frame: Baseline, Week 4
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 20 Nov 2024.
- Results publication: PubMed 33239350Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
- Results publication: PubMed 38716241Canton-Martinez E, Renteria I, Machado-Parra JP, Reyes RA, Moncada-Jimenez J, Johnson DK, Gonzalez OM, Del Valle AS, Jimenez-Maldonado A. A virtually supervised exercise program improved fitness and mental wellness in healthy and comorbidity older adult individuals during the COVID-19 pandemic. Front Public Health. 2024 Apr 23;12:1328518. doi: 10.3389/fpubh.2024.1328518. eCollection 2024.
- Results publication: PubMed 35185739D'Oliveira A, De Souza LC, Langiano E, Falese L, Diotaiuti P, Vilarino GT, Andrade A. Home Physical Exercise Protocol for Older Adults, Applied Remotely During the COVID-19 Pandemic: Protocol for Randomized and Controlled Trial. Front Psychol. 2022 Feb 4;13:828495. doi: 10.3389/fpsyg.2022.828495. eCollection 2022.
- Derived from this study: PubMed 40898552Bayrak G, Aslan UB. Four-week remotely supervised aerobic exercise during the COVID-19 era: Exploring physical performance and psychosocial health in adults without COVID-19 living in rural settings. Medicine (Baltimore). 2025 Aug 29;104(35):e44016. doi: 10.1097/MD.0000000000044016.
- Individual participant dataSharing planned: No. I do not have a plan to make individual participant data available to other researchers
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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.
Gökhan Bayrak, PhD principal investigator
Muş Alparslan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online aerobic exercise in people with Exercise, run by Muş Alparslan University at 1 site 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 7 inclusion and 2 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Physical Activity Level (time frame: Baseline, Week 4). 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?
On the ClinicalTrials.gov record for NCT06517771, which also lists 4 linked publications.
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 20 Nov 2024.