Post-Traumatic Stress DisorderEX-PTSDNCT07474259
Aerobic Exercise Intervention for PTSD Symptoms and Sleep Quality After Earthquake
A study testing Moderate-Intensity Aerobic Exercise Program in people with Post-Traumatic Stress Disorder and Sleep Disturbance, run by Malatya Turgut Ozal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder, Sleep Disturbance
- What is being tested?
- Moderate-Intensity Aerobic Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Experienced the February 6, 2023 earthquake
- Aged between 18 and 65 years
- Able to read and understand Turkish
- Provided written informed consent to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Turgut Ozal University Training and Research Hospital
Malatya, Malatya, 44330
About this study
Official title: Effects of Aerobic Exercise on PTSD and Sleep: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder, Sleep Disturbance
- Being tested
- Moderate-Intensity Aerobic Exercise Program
- Keywords
- Aerobic exercise; posttraumatic stress disorder; sleep quality; earthquake survivors; randomized controlled trial
- Medical subject headings
- Stress Disorders, Post-Traumatic, Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Aerobic Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 weeks (post-intervention)
Secondary outcomes (1)
Sleep Quality
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).
Measured: Baseline and 3 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Sep 2025
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malatya Turgut Ozal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Ceviz, Malatya Turgut Ozal University
- Investigators
- Rana Ceviz, RN, MSc, Principal investigator, Malatya Turgut Ozal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474259
- Sponsor's protocol ID
- OZAL-TN-RC-01
- Acronym
- EX-PTSD
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Adhikari Baral I, K C B. Post traumatic stress disorder and coping strategies among adult survivors of earthquake, Nepal. BMC Psychiatry. 2019 Apr 18;19(1):118. doi: 10.1186/s12888-019-2090-y.
PubMed 30999893Alnawwar MA, Alraddadi MI, Algethmi RA, Salem GA, Salem MA, Alharbi AA. The Effect of Physical Activity on Sleep Quality and Sleep Disorder: A Systematic Review. Cureus. 2023 Aug 16;15(8):e43595. doi: 10.7759/cureus.43595. eCollection 2023 Aug.
PubMed 37719583Blevins 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.
PubMed 26606250Chen 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.
PubMed 33418432Buysse 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.
PubMed 2748771Bryant 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.
PubMed 36436532
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise on PTSD and Sleep: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07474259
- Acronym / sponsor ID
- EX-PTSD / OZAL-TN-RC-01
- Conditions
- Post-Traumatic Stress Disorder, Sleep Disturbance
- Keywords
- Aerobic exercise; posttraumatic stress disorder; sleep quality; earthquake survivors; randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Malatya Turgut Ozal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Experimental | Behavioral: Moderate-Intensity Aerobic Exercise ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Experienced the February 6, 2023 earthquake
- Aged between 18 and 65 years
- Able to read and understand Turkish
- Provided written informed consent to participate
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-Intensity Aerobic Exercise ProgramA 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. | Behavioural | Aerobic Exercise Group |
Primary outcome
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.
1 secondary outcome
Sleep Quality
Time frame: Baseline and 3 weeks (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 30999893Adhikari Baral I, K C B. Post traumatic stress disorder and coping strategies among adult survivors of earthquake, Nepal. BMC Psychiatry. 2019 Apr 18;19(1):118. doi: 10.1186/s12888-019-2090-y.
- Background: PubMed 37719583Alnawwar MA, Alraddadi MI, Algethmi RA, Salem GA, Salem MA, Alharbi AA. The Effect of Physical Activity on Sleep Quality and Sleep Disorder: A Systematic Review. Cureus. 2023 Aug 16;15(8):e43595. doi: 10.7759/cureus.43595. eCollection 2023 Aug.
- Background: PubMed 26606250Blevins 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.
- Background: PubMed 33418432Chen 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.
- Background: PubMed 2748771Buysse 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.
- Background: PubMed 36436532Bryant 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Post-Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana Ceviz, RN, MSc principal investigator
Malatya Turgut Ozal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Aerobic Exercise Program in people with Post-Traumatic Stress Disorder and Sleep Disturbance, run by Malatya Turgut Ozal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Posttraumatic Stress Symptoms (time frame: Baseline and 3 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07474259, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.