NCT07181460

Brief Summary

The primary objective of this study was to examine the effects of regular exercise on sleep quality in older adults. The study will assess changes in sleep quality resulting from a structured exercise program using objective and subjective measurement tools.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

September 11, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

Sleep QualityElderlyExercisesTelerehabilitation

Outcome Measures

Primary Outcomes (5)

  • Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a 19-item self-report measure widely used in clinical and research settings that measures sleep quality and sleep-related disturbances based on self-report over a one-month period.

    16 weeks

  • SF-12 / Short Form-12 Health Survey

    The SF-12 is a brief, validated health status scale derived from the SF-36 and enhanced to reproduce physical and mental component summary scores with 12 questions to reduce response burden for group comparisons.

    16 weeks

  • Modified Medical Research Council (mMRC) Dyspnea Scale

    The mMRC is a brief, five-point self-assessment scale from 0 to 4 that rates the impact of breathlessness on daily activities and is commonly used to classify symptom severity in respiratory diseases such as COPD.

    16 weeks

  • Timed Up and Go (TUG) Test

    The TUG test is described as a rapid way to quantify baseline functional mobility and fall risk in which the time it takes for the patient to get up from a chair, walk 3 meters, turn, and sit down again is measured chronometrically.

    16 weeks

  • 6-Minute Walk Test (6MWT)

    The 6MWT is a submaximal exercise capacity test that measures the total distance a patient walks in 6 minutes; detailed guidelines for its application, safety, evaluation, and interpretation have been published by the American Thoracic Society.

    16 weeks

Study Arms (1)

Experimental: Study Group

EXPERIMENTAL

The sample size was determined as 18 elderly individuals.

Other: Exercises Program

Interventions

A program of low-intensity, safe, and functional movements was designed for older adults. It included a warm-up, breathing exercises, chair exercises, strength and mobility exercises, balance exercises, stretching, and a cool-down.

Experimental: Study Group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being 65 years of age or older,
  • Being a resident of the Kadıköy Municipality Social Life House,
  • Being able to independently carry out daily living activities,
  • Not having any serious cardiopulmonary, neurological, or orthopedic health problems that would prevent exercise,
  • Being willing to participate in the study and providing written consent,
  • Being at a level where cognitive status does not prevent participation in exercise.

You may not qualify if:

  • Those with serious cardiopulmonary, neurological, or orthopedic diseases,
  • Individuals who exercise regularly,
  • Individuals who did not complete the study process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersMotor Activity

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavior

Study Officials

  • Feryal Subaşı

    Yeditepe University

    PRINCIPAL INVESTIGATOR
  • Dilara Karaoğlu

    Yeditepe University

    STUDY DIRECTOR
  • Deniz Aslan, MSc

    Yeditepe University

    STUDY CHAIR
  • Irmak Sıla Çetinel

    Yeditepe University

    STUDY CHAIR

Central Study Contacts

Elif Develi, PhD C

CONTACT

Mehmet Alperen Pekdaş, PhD C

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 18, 2025

Study Start

November 15, 2025

Primary Completion

March 15, 2026

Study Completion

April 15, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations