Effectiveness of Synchronized Tele-exercise

Sponsor
Okan University (Other)
Overall Status
Completed
CT.gov ID
NCT06097624
Collaborator
Ankara Medipol University (Other), Istanbul University - Cerrahpasa (IUC) (Other), Duha Saydam Physical Therapy and Clinical Pilates Center (name of the center) (Other), Ozel Uç Ufuk Çizgisi Special Education and Rehabilitation Center (name of the center (Other)
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: synchronized tele-exercise
N/A

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

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Masking Description:
Examiners and researchers who are going to run the data analysis will be blinded to the assignment
Primary Purpose:
Treatment
Official Title:
Effectiveness of Synchronized Tele-exercise on Sleep Quality and Quality of Life for Healthy Young Adults: A Randomized Double-blind Controlled Trial
Actual Study Start Date :
Sep 10, 2021
Actual Primary Completion Date :
Nov 10, 2021
Actual Study Completion Date :
Dec 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise

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.

Other: synchronized tele-exercise
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.

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

  1. The Pittsburgh Sleep Quality Index (PSQI) [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) [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 [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 [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 Outcome Measures

  1. Body Perception [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 [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 [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 [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 [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 [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'.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Okan University Istanbul Turkey

Sponsors and Collaborators

  • Okan University
  • Ankara Medipol University
  • Istanbul University - Cerrahpasa (IUC)
  • 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Begüm Okudan, Researcher, Okan University
ClinicalTrials.gov Identifier:
NCT06097624
Other Study ID Numbers:
  • 223091
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 24, 2023