- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474259
Aerobic Exercise Intervention for PTSD Symptoms and Sleep Quality After Earthquake (EX-PTSD)
Effects of Aerobic Exercise on PTSD and Sleep: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Natural disasters such as earthquakes can lead to significant psychological consequences, including post-traumatic stress disorder (PTSD) and sleep disturbances. Individuals who experience earthquakes and continue to live in temporary accommodation conditions may remain exposed to ongoing stressors that negatively affect their mental health and overall well-being.
Physical activity has been suggested as a potentially beneficial non-pharmacological intervention for improving psychological health and sleep quality. Aerobic exercise in particular has been shown to reduce stress, improve mood, and regulate sleep patterns. However, there is limited evidence regarding the effectiveness of structured aerobic exercise programs for earthquake survivors living in temporary settlement areas.
This randomized controlled study investigates the effects of a moderate-intensity aerobic exercise program on PTSD symptoms and sleep quality among adult earthquake survivors residing in temporary accommodation centers. Participants who meet the inclusion criteria are randomly assigned to an intervention group or a control group. The intervention group participates in supervised aerobic exercise sessions conducted twice per week for three weeks, resulting in a total of six exercise sessions. The control group continues their routine daily activities without participating in the exercise program.
Outcome measures include PTSD symptom severity and sleep quality assessed before and after the intervention using validated scales. The findings of this study are expected to contribute to the development of evidence-based psychosocial and behavioral interventions aimed at improving mental health outcomes among populations affected by natural disasters.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Malatya
-
Malatya, Malatya, Turkey (Türkiye), 44330
- Malatya Turgut Özal University Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Experienced the February 6, 2023 earthquake
- Aged between 18 and 65 years
- Able to read and understand Turkish
- Provided written informed consent to participate
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic Exercise Group
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.
|
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.
|
|
No Intervention: Control Group
Participants in the control group did not receive any structured exercise intervention during the study period and continued their usual daily routines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Posttraumatic Stress Symptoms
Time Frame: Baseline and 3 weeks (post-intervention)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Quality
Time Frame: Baseline and 3 weeks (post-intervention)
|
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).
|
Baseline and 3 weeks (post-intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rana Ceviz, RN, MSc, Malatya Turgut Ozal University
Publications and helpful links
General Publications
- 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.
- 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.
- Adhikari Baral I,K C B
- Alnawwar MA,Alraddadi MI,Algethmi RA,Salem GA,Salem MA,Alharbi AA
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OZAL-TN-RC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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