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Completed

NCT Number: NCT06097624

Effectiveness of Synchronized Tele-exercise

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.

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Key information

Conditions

Healthy

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Okan University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being a volunteer,
  • being in the age range of 18-25,
  • having no barriers to online sessions through a computer,
  • having no visual impairment.

Exclusion criteria

  • 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

Treatment and study plan

synchronized tele-exercise

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Body Perception

    Time frame: 0th week

    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'.

  2. Body Perception

    Time frame: 4th week

    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'.

  3. Perception of General Health

    Time frame: 0th week

    Participants will be asked to rate their perceived general health using a 10-point Likert scale; 1 indicating 'Very poor', 10 indicating 'Excellent'.

  4. Perception of General Health

    Time frame: 4th week

    Participants will be asked to rate their perceived general health using a 10-point Likert scale; 1 indicating 'Very poor', 10 indicating 'Excellent'.

  5. Perception of Physical Fitness

    Time frame: 0th week

    Participants will be asked to rate their perceived physical fitness using a 10-point Likert scale; 1 indicating 'Very poor', 10 indicating 'Excellent'.

  6. Perception of Physical Fitness

    Time frame: 4th week

    Participants will be asked to rate their perceived physical fitness using a 10-point Likert scale; 1 indicating 'Very poor', 10 indicating 'Excellent'.

Sponsors and collaborators

Lead sponsor

Okan University

Other

Collaborators

  • Ankara Medipol University
  • Duha Saydam Physical Therapy and Clinical Pilates Center (name of the center)
  • Istanbul University - Cerrahpasa
  • Ozel Uç Ufuk Çizgisi Special Education and Rehabilitation Center (name of the center

Registry information

Official study title

Effectiveness of Synchronized Tele-exercise on Sleep Quality and Quality of Life for Healthy Young Adults: A Randomized Double-blind Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 24, 2023
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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