Biopsychosocial Effectiveness of Exercise Trainings in Earthquake Survivors With Post-Traumatic Stress Disorder
NCT ID: NCT06390618
Last Updated: 2024-06-17
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2024-06-25
2025-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aerobic Exercise Group (AE)
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.
Aerobic Exercise (AE) Group
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) Group
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.
Combined Exercise (CE) Group
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.
Control Group (C)
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.
No interventions assigned to this group
Interventions
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Aerobic Exercise (AE) Group
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) Group
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-65 years old
* Individuals who agree to participate in the study voluntarily
Exclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Erkin Oğuz SARI
OTHER
Responsible Party
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Erkin Oğuz SARI
Research Assistant
Locations
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Hasan Kalyoncu University
Gaziantep, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Ahmed 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.
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.
Gibbons 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.
Horowitz 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.
Kukihara 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.
Kuroda 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.
Lovibond 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.
Manger 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.
Momma 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.
Thordardottir 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.
Tian 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.
Tsuji 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.
Zahid 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.
Other Identifiers
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HKU-FTR-EOS-01
Identifier Type: -
Identifier Source: org_study_id
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