NCT06097624

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 18, 2023

Last Update Submit

October 23, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Body Perception

    0th week

  • Body Perception

    4th week

  • Perception of General Health

    0th week

  • Perception of General Health

    4th week

  • Perception of Physical Fitness

    0th week

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Exercise

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Okan University

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Examiners and researchers who are going to run the data analysis will be blinded to the assignment
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 24, 2023

Study Start

September 10, 2021

Primary Completion

November 10, 2021

Study Completion

December 10, 2021

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations