NCT07474259

Brief Summary

This randomized controlled trial aims to examine the effects of a moderate-intensity aerobic exercise program on post-traumatic stress disorder (PTSD) symptoms and sleep quality among earthquake survivors living in temporary accommodation centers. Participants are randomly assigned to either an exercise intervention group or a control group. The intervention group participates in supervised aerobic exercise sessions twice per week for three weeks. PTSD symptoms and sleep quality are assessed before and after the intervention using validated measurement tools. The study aims to provide evidence on the effectiveness of structured aerobic exercise in improving psychological well-being and sleep quality among individuals affected by natural disasters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 11, 2026

Last Update Submit

March 14, 2026

Conditions

Keywords

Aerobic exercise; posttraumatic stress disorder; sleep quality; earthquake survivors; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Change in Posttraumatic Stress Symptoms

    Posttraumatic stress symptom severity measured using the PTSD Checklist for DSM-5 (PCL-5). Scores will be compared between baseline and post-intervention to evaluate the effect of the aerobic exercise program.

    Baseline and 3 weeks (post-intervention)

Secondary Outcomes (1)

  • Sleep Quality

    Baseline and 3 weeks (post-intervention)

Study Arms (2)

Aerobic Exercise Group

EXPERIMENTAL

Participants assigned to this group participated in a structured moderate-intensity aerobic exercise program consisting of six group sessions delivered over three weeks. Each session included warm-up, aerobic exercise activities, and cool-down exercises. The program was designed to improve posttraumatic stress symptoms and sleep quality among earthquake survivors.

Behavioral: Moderate-Intensity Aerobic Exercise Program

Control Group

NO INTERVENTION

Participants in the control group did not receive any structured exercise intervention during the study period and continued their usual daily routines.

Interventions

A structured moderate-intensity aerobic exercise program delivered in group sessions over three weeks. The program consisted of six sessions including warm-up exercises, aerobic activity, and cool-down periods. The intervention aimed to reduce posttraumatic stress symptoms and improve sleep quality among earthquake survivors living in temporary accommodation settings.

Aerobic Exercise Group

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Experienced the February 6, 2023 earthquake
  • Aged between 18 and 65 years
  • Able to read and understand Turkish
  • Provided written informed consent to participate

You may not qualify if:

  • Younger than 18 years or older than 65 years
  • Incomplete or invalid questionnaire responses
  • Insufficient literacy to complete the study instruments
  • History of severe psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Turgut Ozal University Training and Research Hospital

Malatya, Malatya, 44330, Turkey (Türkiye)

Location

Related Publications (6)

  • Adhikari Baral I,K C B

    BACKGROUND
  • Alnawwar MA,Alraddadi MI,Algethmi RA,Salem GA,Salem MA,Alharbi AA

    BACKGROUND
  • Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

    PMID: 26606250BACKGROUND
  • Chen XY, Shi X, Li Y, Zhou Y, Chen H, Wang T, Fan F. Psychiatric comorbidity predicts sleep disturbances among adolescent earthquake survivors: a 10-year cohort study. Sleep Med. 2021 Feb;78:94-100. doi: 10.1016/j.sleep.2020.12.015. Epub 2020 Dec 21.

    PMID: 33418432BACKGROUND
  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PMID: 2748771BACKGROUND
  • Bryant RA, Dawson KS, Azevedo S, Yadav S, Cahill C, Kenny L, Maccallum F, Tran J, Rawson N, Tockar J, Garber B, Keyan D. Augmenting trauma-focused psychotherapy for post-traumatic stress disorder with brief aerobic exercise in Australia: a randomised clinical trial. Lancet Psychiatry. 2023 Jan;10(1):21-29. doi: 10.1016/S2215-0366(22)00368-6. Epub 2022 Nov 24.

    PMID: 36436532BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticParasomniasSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSleep Wake DisordersNervous System DiseasesSleep Disorders, IntrinsicDyssomnias

Study Officials

  • Rana Ceviz, RN, MSc

    Malatya Turgut Ozal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either an aerobic exercise intervention group or a control group. The intervention group participated in a supervised moderate-intensity aerobic exercise program conducted twice weekly for three weeks (six sessions in total), while the control group continued their usual daily activities without structured exercise.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

September 1, 2025

Primary Completion

February 15, 2026

Study Completion

February 15, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical and confidentiality considerations. The dataset contains potentially identifiable information from earthquake survivors residing in temporary accommodation settings, and sharing individual-level data could compromise participant privacy.

Locations