Effectiveness of Synchronized Tele-exercise

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: synchronized tele-exercise

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Okan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	4th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	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'.	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'.	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'.	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'.	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'.	4th week

Collaborators and Investigators

• Sponsor: Okan University
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): November 10, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 223091

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