HealthyNCT06097624
Effectiveness of Synchronized Tele-exercise
A study testing synchronized tele-exercise in people with Healthy, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. This study is planned as a randomized double-blind controlled clinical study. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- synchronized tele-exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2021to 10 Dec 2021
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being a volunteer,
- being in the age range of 18-25,
- having no barriers to online sessions through a computer,
- having no visual impairment.
Who cannot join
- having experienced a physical injury in the last 3 months
- having any major disorder,
- learning difficulty,
- having a mental disorder that could affect the results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Synchronized Tele-exercise on Sleep Quality and Quality of Life for Healthy Young Adults: A Randomized Double-blind Controlled Trial
The aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. This study is planned as a randomized double-blind controlled clinical study.
Read the detailed description
The aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. This study is planned as a randomized double-blind controlled clinical study. The sample size was calculated using G*power 3.1.9.2, which required 42 patients and a size effect of 0.8, 80% power, 1:1 allocation ratio, and an error probability of 0.05. Forty-eight participants were planned to be included in the study, based on the probability that 15% of the patients could be excluded.
- Conditions
- Healthy
- Being tested
- synchronized tele-exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synchronized tele-exerciseOther
All evaluations and exercise interventions will be performed by via Google Meet, a video-conferencing application. The participation link will be sent to the individual by the researcher before each session. In case of any technological disruption, the session will be postponed to the nearest available time by phone. All interventions will be run by a blinded researcher.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | The exercises will be applied three times a week for four weeks. Each exercise is going to start with 10 repetitions and 1 set in the first session, and the exercises will be revised at the beginning of each week. Resistance will gradually be increased, and after four weeks, 3 sets of 10 repetitions will be targeted. Receives: Other: synchronized tele-exercise |
| Control | No intervention | After a waiting period of four weeks, the participants will be contacted for reevaluation, and at the end of the assessment, an individual home exercise program will be created for them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire that assesses sleep quality over the last month. Its adaptation to Turkish and its reliability and validity analyses were carried out in 1996 by Ağargün el al. It covers seven components of sleep each of which are scored between 0-3: sleep duration, sleep disturbances, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use. The PSQI provides a global score that ranges from 0 to 21, with higher scores indicating poorer sleep quality: smaller than 5, the score points to "Good Sleep Quality"; greater than or equal to 5, it indicates poor sleep quality (Buysee 1989, Agargun 1996). PSQI is a reliable and valid tool for assessing sleep quality in clinical and research settings.
Measured: 0th week
The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire that assesses sleep quality over the last month. Its adaptation to Turkish and its reliability and validity analyses were carried out in 1996 by Ağargün el al. It covers seven components of sleep each of which are scored between 0-3: sleep duration, sleep disturbances, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use. The PSQI provides a global score that ranges from 0 to 21, with higher scores indicating poorer sleep quality: smaller than 5, the score points to "Good Sleep Quality"; greater than or equal to 5, it indicates poor sleep quality (Buysee 1989, Agargun 1996). PSQI is a reliable and valid tool for assessing sleep quality in clinical and research settings.
Measured: 4th week
World Health Organization Quality of Life-Brief Form
The WHOQOL is based on a purely subjective evaluation to assess the perceived quality of life. The short version, the World Health Organization Quality of Life-Brief Form (WHOQOL-BREF) is a 26-item self-report questionnaire that assesses the quality of life (QOL) within the context of an individual's culture, value systems, personal goals, standards, and concerns. It covers four domains: physical health, psychological health, social relationships, and environmental health.
Measured: 0th week
World Health Organization Quality of Life-Brief Form
The WHOQOL is based on a purely subjective evaluation to assess the perceived quality of life. The short version, the World Health Organization Quality of Life-Brief Form (WHOQOL-BREF) is a 26-item self-report questionnaire that assesses the quality of life (QOL) within the context of an individual's culture, value systems, personal goals, standards, and concerns. It covers four domains: physical health, psychological health, social relationships, and environmental health.
Measured: 4th week
Secondary outcomes (6)
Body Perception
Participants will be asked to choose how they perceived their current body image, or "how they look'. Body mass index (BMI) classification will be used: 'Underweight', 'Healthy weight', 'Overweight', 'Obese', 'Severely obese'.
Measured: 0th week
Body Perception
Participants will be asked to choose how they perceived their current body image, or "how they look'. Body mass index (BMI) classification will be used: 'Underweight', 'Healthy weight', 'Overweight', 'Obese', 'Severely obese'.
Measured: 4th week
Perception of General Health
Participants will be asked to rate their perceived general health using a 10-point Likert scale; 1 indicating 'Very poor', 10 indicating 'Excellent'.
Measured: 0th week
Perception of General Health
Participants will be asked to rate their perceived general health using a 10-point Likert scale; 1 indicating 'Very poor', 10 indicating 'Excellent'.
Measured: 4th week
Perception of Physical Fitness
Participants will be asked to rate their perceived physical fitness using a 10-point Likert scale; 1 indicating 'Very poor', 10 indicating 'Excellent'.
Measured: 0th week
Perception of Physical Fitness
Participants will be asked to rate their perceived physical fitness using a 10-point Likert scale; 1 indicating 'Very poor', 10 indicating 'Excellent'.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start10 Sep 2021
- Primary completion10 Nov 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Medipol University, Istanbul University - Cerrahpasa, Duha Saydam Physical Therapy and Clinical Pilates Center (name of the center), Ozel Uç Ufuk Çizgisi Special Education and Rehabilitation Center (name of the center
- Responsible party
- Principal investigator, Begüm Okudan, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097624
- Sponsor's protocol ID
- 223091
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 24 Oct 2023
- 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Synchronized Tele-exercise on Sleep Quality and Quality of Life for Healthy Young Adults: A Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT06097624
- Acronym / sponsor ID
- 223091
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Ankara Medipol University, Istanbul University - Cerrahpasa, Duha Saydam Physical Therapy and Clinical Pilates Center (name of the center), Ozel Uç Ufuk Çizgisi Special Education and Rehabilitation Center (name of the center
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 24 Oct 2023 (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.
The aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. This study is planned as a randomized double-blind controlled clinical study.
Detailed description
The aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. This study is planned as a randomized double-blind controlled clinical study. The sample size was calculated using G*power 3.1.9.2, which required 42 patients and a size effect of 0.8, 80% power, 1:1 allocation ratio, and an error probability of 0.05. Forty-eight participants were planned to be included in the study, based on the probability that 15% of the patients could be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: synchronized tele-exerciseThe exercises will be applied three times a week for four weeks. Each exercise is going to start with 10 repetitions and 1 set in the first session, and the exercises will be revised at the beginning of each week. Resistance will gradually be increased, and after four weeks, 3 sets of 10 repetitions will be targeted. |
| Control | No intervention | –After a waiting period of four weeks, the participants will be contacted for reevaluation, and at the end of the assessment, an individual home exercise program will be created for them. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- being a volunteer,
- being in the age range of 18-25,
- having no barriers to online sessions through a computer,
- having no visual impairment.
Key exclusion criteria (4 listed)
- having experienced a physical injury in the last 3 months
- having any major disorder,
- learning difficulty,
- having a mental disorder that could affect the results
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 |
|---|---|---|
| synchronized tele-exerciseAll evaluations and exercise interventions will be performed by via Google Meet, a video-conferencing application. The participation link will be sent to the individual by the researcher before each session. In case of any technological disruption, the session will be postponed to the nearest available time by phone. All interventions will be run by a blinded researcher. | Other | Exercise |
Primary outcome
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 0th week
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire that assesses sleep quality over the last month. Its adaptation to Turkish and its reliability and validity analyses were carried out in 1996 by Ağargün el al. It covers seven components of sleep each of which are scored between 0-3: sleep duration, sleep disturbances, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use. The PSQI provides a global score that ranges from 0 to 21, with higher scores indicating poorer sleep quality: smaller than 5, the score points to "Good Sleep Quality"; greater than or equal to 5, it indicates poor sleep quality (Buysee 1989, Agargun 1996). PSQI is a reliable and valid tool for assessing sleep quality in clinical and research settings.
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4th week
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire that assesses sleep quality over the last month. Its adaptation to Turkish and its reliability and validity analyses were carried out in 1996 by Ağargün el al. It covers seven components of sleep each of which are scored between 0-3: sleep duration, sleep disturbances, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use. The PSQI provides a global score that ranges from 0 to 21, with higher scores indicating poorer sleep quality: smaller than 5, the score points to "Good Sleep Quality"; greater than or equal to 5, it indicates poor sleep quality (Buysee 1989, Agargun 1996). PSQI is a reliable and valid tool for assessing sleep quality in clinical and research settings.
World Health Organization Quality of Life-Brief Form
Time frame: 0th week
The WHOQOL is based on a purely subjective evaluation to assess the perceived quality of life. The short version, the World Health Organization Quality of Life-Brief Form (WHOQOL-BREF) is a 26-item self-report questionnaire that assesses the quality of life (QOL) within the context of an individual's culture, value systems, personal goals, standards, and concerns. It covers four domains: physical health, psychological health, social relationships, and environmental health.
World Health Organization Quality of Life-Brief Form
Time frame: 4th week
The WHOQOL is based on a purely subjective evaluation to assess the perceived quality of life. The short version, the World Health Organization Quality of Life-Brief Form (WHOQOL-BREF) is a 26-item self-report questionnaire that assesses the quality of life (QOL) within the context of an individual's culture, value systems, personal goals, standards, and concerns. It covers four domains: physical health, psychological health, social relationships, and environmental health.
6 secondary outcomes
Body Perception
Time frame: 0th week
Body Perception
Time frame: 4th week
Perception of General Health
Time frame: 0th week
Perception of General Health
Time frame: 4th week
Perception of Physical Fitness
Time frame: 0th week
Perception of Physical Fitness
Time frame: 4th week
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 24 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing synchronized tele-exercise in people with Healthy, run by Okan 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 4 inclusion and 4 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 24 Oct 2023. 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?
The Pittsburgh Sleep Quality Index (PSQI) (time frame: 0th week). The study lists 4 primary outcomes in all. 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 24 Oct 2023.