Post-Traumatic Stress DisorderNCT06390618
Biopsychosocial Effectiveness of Exercise Trainings in Earthquake Survivors With Post-Traumatic Stress Disorder
A study testing Aerobic Exercise (AE) Group and Combined Exercise (CE) Group in people with Post-Traumatic Stress Disorder, run by Erkin Oğuz SARI at 1 site in Turkey (Türkiye).
Trial summary
In study, the investigators aim to demonstrate the effectiveness of biopsychosocial-based exercise approach in post-traumatic stress disorder of physiotherapists in post-earthquake disaster management. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Aerobic Exercise (AE) Group and Combined Exercise (CE) Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2024to 31 Jan 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with earthquake-related post-traumatic stress disorder (PTSD)
- 18-65 years old
- Individuals who agree to participate in the study voluntarily
Who cannot join
- Individuals with another psychiatric diagnosis
- Individuals with a body mass index of more than 35 kg/m2
- Individuals with a history of another trauma
- Pregnant women
- Individuals with neurological findings
- Individuals with malignancy, rheumatological, metabolic bone disease
Show all 12Show fewer
- Individuals with a history of columna vertebralis and lower extremity surgery
- Individuals with severe osteoporosis
- Individuals who are illiterate and have communication problems
- Individuals with hearing problems
- Individuals who do not attend treatment regularly
- Individuals continuing another physiotherapy program
Trial locations and contacts
1 site in 1 country.
Kezban BAYRAMLAR contact
Turkey (Türkiye)1 site
Hasan Kalyoncu University
Gaziantep
Erkin Oğuz SARI, research assistant, 0538 403 6433, eoguz.sari@hku.edu.tr
About this study
Official title: Investigation of the Biopsychosocial Effectiveness of Different Exercise Trainings in Earthquake Survivors With Post-Traumatic Stress Disorder
In study, the investigators aim to demonstrate the effectiveness of biopsychosocial-based exercise approach in post-traumatic stress disorder of physiotherapists in post-earthquake disaster management.
Read the detailed description
The aim of this study is to compare the effects of aerobic exercise and biopsychosocial exercise in addition to aerobic exercise on functional capacity, trauma symptoms, depression, anxiety, stress, sleep quality, quality of life and biopsychosocial status in earthquake victims with post-traumatic stress disorder (PTSD).
Individuals will be randomized using the covariate adaptive randomization method. According to this randomization, they will be divided into 3 groups: aerobic exercise group (AE), combined exercise (CE) group, in which biopsychosocial exercise is performed in addition to aerobic exercise, and control group (C).
A total of 16 sessions of treatment will be performed in 8 weeks, 2 days a week. In the control group, no intervention will be made. The change over time in the control group and individuals with post-traumatic stress disorder will be monitored.
Questionnaires for quantitative data before treatment and 8 weeks after treatment; Data will also be collected through interview questions for qualitative data about experience/change after 8 weeks of treatment. In our study, mixed methods research will be used because it is thought that the survey data can be more descriptive and meaningful by supporting qualitative interview questions. Explanatory sequential mixed methods type will be used as a mixed methods research design. According to this design, quantitative data will be collected first and then qualitative data about the topic to be focused on will be collected from group interviews with semi-structured interview questions. Phenomenology research focuses on the experiences of participants. Phenomenological research method will be used in qualitative research.
A moderate intensity (50-60%) aerobic exercise program will be applied 3 days a week, using the karvonen method for aerobic exercise. According to the aerobic exercise intensity karvonen method, the formula "(Maximal Heart Rate (220-years) - Resting Heart Rate) x 50-60% + Resting Heart Rate)" will be used. 1-4. week 50%, 5-8. Exercise intensity will be increased by 60% per week.
Cognitive Exercise Therapy Approach (BETY) will be applied as a biopsychosocial exercise. BETY method is a patient-centered biopsychosocial approach and a holistic treatment option. On the basis of the BETY session, warm-up movements, exercises and cooling movements will be performed sequentially. While authentic movements are performed accompanied by music as dance therapy during the warm-up and cool-down period, functional trunk stabilization exercises are used during the exercises period. In addition, cognitive change is aimed by expressing positive and negative emotions during side lying exercises. Social support will also be provided by holding BETY sessions as a group. Thus, the aim is biological recovery with exercises, psychological recovery by expressing negative-positive thoughts during exercises and emphasizing staying in positive thoughts, and social recovery with group treatment.
After the data are collected, a randomized controlled double-blind study will be conducted by ensuring the blindness of the evaluator and the statistician. Blinding will be achieved by assigning numbers to randomized patients and keeping the evaluator and statistician from knowing which patient is in which group. To calculate the sample size, power analysis will be made by referring to similar studies.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Aerobic Exercise (AE) Group, Combined Exercise (CE) Group
- Keywords
- Post-Traumatic Stress Disorder, Aerobic Exercise, Biopsychosocial Models, Qualitative and Quantitative Evaluation, Physical therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise (AE) GroupOther
A total of 24 sessions of aerobic exercise will be performed in 8 weeks, 3 days a week.
For aerobic exercise, a moderate intensity (50-60%) aerobic exercise program will be applied using the karvonen method. According to the aerobic exercise intensity karvonen method, the formula "(Maximal Heart Rate (220-years) - Resting Heart Rate) x 50-60% + Resting Heart Rate)" will be used. 1-4. week 50%, 5-8. Exercise intensity will be increased by 60% per week.
Combined Exercise (CE) GroupOther
Also called Cognitive Exercise Therapy Approach (BETY)
In the combined exercise group, biopsychosocial exercise will be performed in addition to aerobic exercise.
In the combined exercise group, in addition to aerobic exercise (3, 8 weeks, 24 sessions of aerobic exercise per week), 16 sessions of biopsychosocial-based group exercise treatment will be performed 2 days a week for a total of 8 weeks.
BETY approach will be used in group exercise treatment.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group (AE) | Active comparator | A moderate intensity (50-60%) aerobic exercise program will be applied 3 days a week, using the karvonen method for aerobic exercise. According to the aerobic exercise intensity karvonen method, the formula "(Maximal Heart Rate (220-years) - Resting Heart Rate) x 50-60% + Resting Heart Rate)" will be used. 1-4. week 50%, 5-8. Exercise intensity will be increased by 60% per week. Receives: Other: Aerobic Exercise (AE) Group |
| Combined Exercise (CE) Group | Active comparator | The group in which biopsychosocial exercise is performed in addition to aerobic exercise is the combined exercise (CE) group. Cognitive Exercise Therapy Approach (BETY) will be applied with group exercise as a biopsychosocial exercise. In the BETY biopsychosocial model, it is aimed to achieve biological recovery with function-oriented trunk stabilization exercises, psychological recovery by expressing negative-positive thoughts during the exercises and emphasizing staying in positive thoughts, and social recovery through group treatment. Receives: Other: Combined Exercise (CE) Group |
| Control Group (C) | No intervention | There will be no intervention in the control group. The change over time in the control group and individuals with post-traumatic stress disorder will be monitored. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)
BETY-BQ scale consists of 30 different items. The five-point Likert system of the BETY scale evaluates dimensions such as pain, functionality, mood, sociability, sexuality and sleep quality. Each of the items in the scale is scored between 0-4. The survey is scored between 0-120, and a higher score indicates a poor biopsychosocial situation.
Measured: eight weeks
Qualitative Interview Questions (from group interviews with semi-structured interview questions)
In group interviews, semi-structured interview questions will be asked and voice recordings will be made. Afterwards, the voice recordings will be analyzed.
Measured: eight weeks
Secondary outcomes (7)
6 Minute Walking Test
Functional capacity is evaluated with the 6 Minute Walk Test (6MWT). The test is applied in a 30 m corridor. Before starting the test, patients are asked to walk as fast as they can without running, and are told that they can rest if they feel too short of breath and/or tired, and that the time they rest is included in the test. Before, after and at the first minute of the test, patients' blood pressure, heart rate and oxygen saturation are evaluated with pulse oximetry, and their perceptions of shortness of breath, fatigue and leg fatigue are evaluated with the Modified Borg Scale.
The total distance the patient was able to walk after the test was recorded and will be expressed as a percentage of what was expected.
Measured: eight weeks
Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5)
The PCL-5 is an easily administered self-report measure that maps 20 symptoms of PTSD outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The 20-item self-report measure of PTSD, which is rated on a five-point scale (scored 0-4) and yields a scale score range of 0-80, was expanded from the previous PCL.
The PCL-5 consists of four scales that map PTSD symptom clusters in the DSM-5: reexperiencing (criteria B), avoidance (criteria C), negative changes (criteria D), and hyperarousal (criteria E).
Although the cut-off score of 47 seems appropriate for clinical use, it is thought that using a score of 48 is more reliable in distinguishing individuals with PTSD in community samples.
With the adaptation made by Weathers et al., the items of the scale were increased to 20 items, compatible with PTSD symptoms (Waethers 2013). The adaptation study of PCL in Turkey was carried out by Boysan and his colleagues (Boysan 2017).
Measured: eight weeks
Post-Traumatic Stress Diagnostic Scale (PTSDS)
The scale developed to determine post-traumatic stress disorder is a self-report scale consisting of fifty items. The scale was developed by Foa et al. It is possible to identify people who meet the diagnosis of PTSD and measure the severity of symptoms with the help of a scale with structure and content prepared according to DSM-IV diagnostic criteria. The scale was adapted into Turkish by Işıklı. A total score of 1-10 is considered mild symptoms, 11-20 is considered moderate symptoms, 21-35 is considered moderate-severe symptoms, and scores of 36 and above are considered severe symptoms.
Measured: eight weeks
Impact of Events Scale-Revised (IES-R)
The Impact of Events Scale-R was used to measure post-traumatic symptom severity. The scale was developed by Horowitz et al. to assess subjective distress caused by traumatic events. Depending on the changes in the clinical situation over time, new items from Weiss and Marmar were added to the scale, and the new scale, which increased to 21 items and had three sub-factors, was named Event Impact Scale-R. These sub-dimensions; re-experiencing, avoidance and hyperarousal. It is a self-report scale that measures post-traumatic stress level, adapted into Turkish by Çorapçıoğlu et al.
A scale score of up to 24 points is considered normal, 24 and above is considered partial PTSD, 33 and above is considered the best limit for possible PTSD, and 37 and above is considered PTSD high enough to suppress the immune system.
Measured: eight weeks
Depression Anxiety and Stress Scale (DASS-21)
DASS-21 is the short form of the Depression, Stress and Anxiety Scale, developed by Lovibond and Lovibond, consisting of 42 items. The Turkish reliability and validity study of the scale was conducted by Yılmaz, Boz and Arslan in 2017.
DASS-21 has three subscales: depression, stress and anxiety; There are seven questions in each dimension. The scale is a 4-point Likert type scale (0-Not suitable for me, 1-Sometimes suitable for me, 2-Usually suitable for me and 3-Completely suitable for me). The scores that can be obtained from each subscale vary between 0 and 21. A high score means that you have high levels of depression/anxiety/stress symptoms. If an individual scores 5 points or more on the depression subscale, 4 points or more on the anxiety subscale, and 8 points or more on the stress subscale, it indicates that he or she has a relevant problem.
Measured: eight weeks
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) was developed by Buysse and his team. It was adapted into Turkish by Ağargün et al. in 1996. PSQI is a feedback scale that evaluates sleep quality and disorder over the past month and consists of 24 questions in total.
Seven sub-dimensions, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorder, use of sleeping pills, and daytime dysfunction, are evaluated with 19 questions answered by the adult individual. The sum of the scores on the seven subscales gives the total PSQI score. The score of each subscale varies between 0 and 3. The total PSQI score varies between 0-21. Sleep quality of those with a total score of 5 or less is considered good.
Measured: eight weeks
SF-36 Short Form
The survey contains 36 items. The survey measures health-related quality of life under eight subheadings. It gives results for 8 parameters consisting of physical function, physical role difficulty, emotional role difficulty, energy-vitality-vitality, mental health, social functionality, pain and general health perception. It also allows comparison of current health status with last year in the last item it contains. The scores from each subheading are summed to obtain a score between 0 (poor quality of life) and 100 (good quality of life).
The Turkish validity of the scale used was conducted by Koçyiğit et al. in 1999.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start25 Jun 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- According to randomization, they will be divided into 3 groups: aerobic exercise group (AE), combined exercise (CE) group in which biopsychosocial exercise is performed in addition to aerobic exercise, and control group (C).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erkin Oğuz SARI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erkin Oğuz SARI, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390618
- Sponsor's protocol ID
- HKU-FTR-EOS-01
- Status last verified
- Jun 2024
- First submitted
- 25 Apr 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adhikari SP, Bimali I, Baidya S, Shakya NR. Community-based rehabilitation for physically impaired earthquake victims: An evidence-based practice protocol and its pre-post experimental study. J Family Med Prim Care. 2018 Nov-Dec;7(6):1327-1333. doi: 10.4103/jfmpc.jfmpc_112_18.
PubMed 30613520Ahmed SK, Dhama K, Abdulqadir SO, Omar RM, Ahmed DR, Chakraborty C, Saied AA. The mental health of people in Turkey-Syria earthquake-affected areas needs urgent attention. Asian J Psychiatr. 2023 Jun;84:103573. doi: 10.1016/j.ajp.2023.103573. Epub 2023 Mar 28. No abstract available.
PubMed 37028233Buysse 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 2748771Gibbons WJ, Fruchter N, Sloan S, Levy RD. Reference values for a multiple repetition 6-minute walk test in healthy adults older than 20 years. J Cardiopulm Rehabil. 2001 Mar-Apr;21(2):87-93. doi: 10.1097/00008483-200103000-00005.
PubMed 11314289Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.
PubMed 472086Kukihara H, Yamawaki N, Uchiyama K, Arai S, Horikawa E. Trauma, depression, and resilience of earthquake/tsunami/nuclear disaster survivors of Hirono, Fukushima, Japan. Psychiatry Clin Neurosci. 2014 Jul;68(7):524-33. doi: 10.1111/pcn.12159. Epub 2014 Mar 4.
PubMed 24444298Kuroda Y, Iwasa H, Orui M, Moriyama N, Suemoto CK, Yashiro C, Matsuda K, Yasumura S. Risk Factor for Incident Functional Disability and the Effect of a Preventive Exercise Program: A 4-Year Prospective Cohort Study of Older Survivors from the Great East Japan Earthquake and Nuclear Disaster. Int J Environ Res Public Health. 2018 Jul 6;15(7):1430. doi: 10.3390/ijerph15071430.
PubMed 29986471Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Manger TA, Motta RW. The impact of an exercise program on posttraumatic stress disorder, anxiety, and depression. Int J Emerg Ment Health. 2005 Winter;7(1):49-57.
PubMed 15869081Momma H, Niu K, Kobayashi Y, Huang C, Otomo A, Chujo M, Tadaura H, Nagatomi R. Leg extension power is a pre-disaster modifiable risk factor for post-traumatic stress disorder among survivors of the Great East Japan Earthquake: a retrospective cohort study. PLoS One. 2014 Apr 23;9(4):e96131. doi: 10.1371/journal.pone.0096131. eCollection 2014.
PubMed 24760054Thordardottir K, Gudmundsdottir R, Zoega H, Valdimarsdottir UA, Gudmundsdottir B. Effects of yoga practice on stress-related symptoms in the aftermath of an earthquake: A community-based controlled trial. Complement Ther Med. 2014 Apr;22(2):226-34. doi: 10.1016/j.ctim.2014.01.008. Epub 2014 Feb 2.
PubMed 24731893Tian Y, Wong TK, Li J, Jiang X. Posttraumatic stress disorder and its risk factors among adolescent survivors three years after an 8.0 magnitude earthquake in China. BMC Public Health. 2014 Oct 15;14:1073. doi: 10.1186/1471-2458-14-1073.
PubMed 25318533Tsuji T, Sasaki Y, Matsuyama Y, Sato Y, Aida J, Kondo K, Kawachi I. Reducing depressive symptoms after the Great East Japan Earthquake in older survivors through group exercise participation and regular walking: a prospective observational study. BMJ Open. 2017 Mar 3;7(3):e013706. doi: 10.1136/bmjopen-2016-013706.
PubMed 28258173Zahid M, Unal E, Ozdemir Isik O, Oksuz S, Karakaya J, Erguney Cefle A. The reliability, validity, and responsiveness of Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire for patients with fibromyalgia. Int J Rheum Dis. 2022 Jun;25(6):685-691. doi: 10.1111/1756-185X.14325. Epub 2022 May 3.
PubMed 35505570
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Biopsychosocial Effectiveness of Different Exercise Trainings in Earthquake Survivors With Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06390618
- Acronym / sponsor ID
- HKU-FTR-EOS-01
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Post-Traumatic Stress Disorder, Aerobic Exercise, Biopsychosocial Models, Qualitative and Quantitative Evaluation, Physical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Erkin Oğuz SARIUniversity, hospital or other
- Study start
- 25 Jun 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
In study, the investigators aim to demonstrate the effectiveness of biopsychosocial-based exercise approach in post-traumatic stress disorder of physiotherapists in post-earthquake disaster management.
Detailed description
The aim of this study is to compare the effects of aerobic exercise and biopsychosocial exercise in addition to aerobic exercise on functional capacity, trauma symptoms, depression, anxiety, stress, sleep quality, quality of life and biopsychosocial status in earthquake victims with post-traumatic stress disorder (PTSD).
Individuals will be randomized using the covariate adaptive randomization method. According to this randomization, they will be divided into 3 groups: aerobic exercise group (AE), combined exercise (CE) group, in which biopsychosocial exercise is performed in addition to aerobic exercise, and control group (C).
A total of 16 sessions of treatment will be performed in 8 weeks, 2 days a week. In the control group, no intervention will be made. The change over time in the control group and individuals with post-traumatic stress disorder will be monitored.
Questionnaires for quantitative data before treatment and 8 weeks after treatment; Data will also be collected through interview questions for qualitative data about experience/change after 8 weeks of treatment. In our study, mixed methods research will be used because it is thought that the survey data can be more descriptive and meaningful by supporting qualitative interview questions. Explanatory sequential mixed methods type will be used as a mixed methods research design. According to this design, quantitative data will be collected first and then qualitative data about the topic to be focused on will be collected from group interviews with semi-structured interview questions. Phenomenology research focuses on the experiences of participants. Phenomenological research method will be used in qualitative research.
A moderate intensity (50-60%) aerobic exercise program will be applied 3 days a week, using the karvonen method for aerobic exercise. According to the aerobic exercise intensity karvonen method, the formula "(Maximal Heart Rate (220-years) - Resting Heart Rate) x 50-60% + Resting Heart Rate)" will be used. 1-4. week 50%, 5-8. Exercise intensity will be increased by 60% per week.
Cognitive Exercise Therapy Approach (BETY) will be applied as a biopsychosocial exercise. BETY method is a patient-centered biopsychosocial approach and a holistic treatment option. On the basis of the BETY session, warm-up movements, exercises and cooling movements will be performed sequentially. While authentic movements are performed accompanied by music as dance therapy during the warm-up and cool-down period, functional trunk stabilization exercises are used during the exercises period. In addition, cognitive change is aimed by expressing positive and negative emotions during side lying exercises. Social support will also be provided by holding BETY sessions as a group. Thus, the aim is biological recovery with exercises, psychological recovery by expressing negative-positive thoughts during exercises and emphasizing staying in positive thoughts, and social recovery with group treatment.
After the data are collected, a randomized controlled double-blind study will be conducted by ensuring the blindness of the evaluator and the statistician. Blinding will be achieved by assigning numbers to randomized patients and keeping the evaluator and statistician from knowing which patient is in which group. To calculate the sample size, power analysis will be made by referring to similar studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- According to randomization, they will be divided into 3 groups: aerobic exercise group (AE), combined exercise (CE) group in which biopsychosocial exercise is performed in addition to aerobic exercise, and control group (C).
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group (AE) | Active comparator | Other: Aerobic Exercise (AE) GroupA moderate intensity (50-60%) aerobic exercise program will be applied 3 days a week, using the karvonen method for aerobic exercise. According to the aerobic exercise intensity karvonen method, the formula "(Maximal Heart Rate (220-years) - Resting Heart Rate) x 50-60% + Resting Heart Rate)" will be used. 1-4. week 50%, 5-8. Exercise intensity will be increased by 60% per week. |
| Combined Exercise (CE) Group | Active comparator | Other: Combined Exercise (CE) GroupThe group in which biopsychosocial exercise is performed in addition to aerobic exercise is the combined exercise (CE) group. Cognitive Exercise Therapy Approach (BETY) will be applied with group exercise as a biopsychosocial exercise. In the BETY biopsychosocial model, it is aimed to achieve biological recovery with function-oriented trunk stabilization exercises, psychological recovery by expressing negative-positive thoughts during the exercises and emphasizing staying in positive thoughts, and social recovery through group treatment. |
| Control Group (C) | No intervention | –There will be no intervention in the control group. The change over time in the control group and individuals with post-traumatic stress disorder will be monitored. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals diagnosed with earthquake-related post-traumatic stress disorder (PTSD)
- 18-65 years old
- Individuals who agree to participate in the study voluntarily
Key exclusion criteria (12 listed)
- Individuals with another psychiatric diagnosis
- Individuals with a body mass index of more than 35 kg/m2
- Individuals with a history of another trauma
- Pregnant women
- Individuals with neurological findings
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 |
|---|---|---|
| Aerobic Exercise (AE) GroupA total of 24 sessions of aerobic exercise will be performed in 8 weeks, 3 days a week. For aerobic exercise, a moderate intensity (50-60%) aerobic exercise program will be applied using the karvonen method. According to the aerobic exercise intensity karvonen method, the formula "(Maximal Heart Rate (220-years) - Resting Heart Rate) x 50-60% + Resting Heart Rate)" will be used. 1-4. week 50%, 5-8. Exercise intensity will be increased by 60% per week. | Other | Aerobic Exercise Group (AE) |
| Combined Exercise (CE) GroupAlso: Cognitive Exercise Therapy Approach (BETY)In the combined exercise group, biopsychosocial exercise will be performed in addition to aerobic exercise. In the combined exercise group, in addition to aerobic exercise (3, 8 weeks, 24 sessions of aerobic exercise per week), 16 sessions of biopsychosocial-based group exercise treatment will be performed 2 days a week for a total of 8 weeks. BETY approach will be used in group exercise treatment. | Other | Combined Exercise (CE) Group |
Primary outcome
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)
Time frame: eight weeks
BETY-BQ scale consists of 30 different items. The five-point Likert system of the BETY scale evaluates dimensions such as pain, functionality, mood, sociability, sexuality and sleep quality. Each of the items in the scale is scored between 0-4. The survey is scored between 0-120, and a higher score indicates a poor biopsychosocial situation.
Qualitative Interview Questions (from group interviews with semi-structured interview questions)
Time frame: eight weeks
In group interviews, semi-structured interview questions will be asked and voice recordings will be made. Afterwards, the voice recordings will be analyzed.
7 secondary outcomes
6 Minute Walking Test
Time frame: eight weeks
Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5)
Time frame: eight weeks
Post-Traumatic Stress Diagnostic Scale (PTSDS)
Time frame: eight weeks
Impact of Events Scale-Revised (IES-R)
Time frame: eight weeks
Depression Anxiety and Stress Scale (DASS-21)
Time frame: eight weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: eight weeks
SF-36 Short Form
Time frame: eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Results publication: PubMed 30613520Adhikari SP, Bimali I, Baidya S, Shakya NR. Community-based rehabilitation for physically impaired earthquake victims: An evidence-based practice protocol and its pre-post experimental study. J Family Med Prim Care. 2018 Nov-Dec;7(6):1327-1333. doi: 10.4103/jfmpc.jfmpc_112_18.
- Results publication: PubMed 37028233Ahmed SK, Dhama K, Abdulqadir SO, Omar RM, Ahmed DR, Chakraborty C, Saied AA. The mental health of people in Turkey-Syria earthquake-affected areas needs urgent attention. Asian J Psychiatr. 2023 Jun;84:103573. doi: 10.1016/j.ajp.2023.103573. Epub 2023 Mar 28. No abstract available.
- Results publication: 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.
- Results publication: PubMed 11314289Gibbons WJ, Fruchter N, Sloan S, Levy RD. Reference values for a multiple repetition 6-minute walk test in healthy adults older than 20 years. J Cardiopulm Rehabil. 2001 Mar-Apr;21(2):87-93. doi: 10.1097/00008483-200103000-00005.
- Results publication: PubMed 472086Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.
- Results publication: PubMed 24444298Kukihara H, Yamawaki N, Uchiyama K, Arai S, Horikawa E. Trauma, depression, and resilience of earthquake/tsunami/nuclear disaster survivors of Hirono, Fukushima, Japan. Psychiatry Clin Neurosci. 2014 Jul;68(7):524-33. doi: 10.1111/pcn.12159. Epub 2014 Mar 4.
- Results publication: PubMed 29986471Kuroda Y, Iwasa H, Orui M, Moriyama N, Suemoto CK, Yashiro C, Matsuda K, Yasumura S. Risk Factor for Incident Functional Disability and the Effect of a Preventive Exercise Program: A 4-Year Prospective Cohort Study of Older Survivors from the Great East Japan Earthquake and Nuclear Disaster. Int J Environ Res Public Health. 2018 Jul 6;15(7):1430. doi: 10.3390/ijerph15071430.
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- Individual participant dataSharing planned: No
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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.
Kezban BAYRAMLAR contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise (AE) Group and Combined Exercise (CE) Group in people with Post-Traumatic Stress Disorder, run by Erkin Oğuz SARI 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erkin Oğuz SARI, research assistant (0538 403 64 33, eoguz.sari@hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ) (time frame: eight weeks). The study lists 2 primary outcomes in all. 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 NCT06390618, which also lists 14 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 Jun 2024.