Biopsychosocial Effectiveness of Exercise Trainings in Earthquake Survivors With Post-Traumatic Stress Disorder

NCT06390618 | Not Yet Recruiting DMC

• 1 other identifier: HKU-FTR-EOS-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Traumatic Stress Disorder

Keywords

Post-Traumatic Stress Disorder; Aerobic Exercise; Biopsychosocial Models; Qualitative and Quantitative Evaluation; Physical therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  eight weeks

Secondary Outcomes (7)

• 6 Minute Walking Test

  eight weeks

• Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5)

  eight weeks

• Post-Traumatic Stress Diagnostic Scale (PTSDS)

  eight weeks

• Impact of Events Scale-Revised (IES-R)

  eight weeks

• Depression Anxiety and Stress Scale (DASS-21)

  eight weeks

Study Arms (3)

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.

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.

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.

Interventions

Aerobic Exercise (AE) Group OTHER

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.

Aerobic Exercise Group (AE)

Combined Exercise (CE) Group OTHER

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.

Also known as: Cognitive Exercise Therapy Approach (BETY)

Combined Exercise (CE) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals diagnosed with earthquake-related post-traumatic stress disorder (PTSD)
• years old
• Individuals who agree to participate in the study voluntarily

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Erkin Oğuz SARI: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  PMID: 30613520 RESULT

• 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.

  PMID: 37028233 RESULT

• 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: 2748771 RESULT

• 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.

  PMID: 11314289 RESULT

• 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.

  PMID: 472086 RESULT

• 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.

  PMID: 24444298 RESULT

• 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.

  PMID: 29986471 RESULT

• 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.

  PMID: 7726811 RESULT

• 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.

  PMID: 15869081 RESULT

• 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.

  PMID: 24760054 RESULT

• 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.

  PMID: 24731893 RESULT

• 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.

  PMID: 25318533 RESULT

• 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.

  PMID: 28258173 RESULT

• 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.

  PMID: 35505570 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Exercise; Population Groups

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Demography; Population Characteristics

Central Study Contacts

Erkin Oğuz SARI, research assistant

CONTACT

0538 403 64 33; eoguz.sari@hku.edu.tr

Kezban BAYRAMLAR

CONTACT

kezban.bayramlar@hku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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).

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: June 25, 2024
• Primary Completion: November 30, 2024
• Study Completion: January 31, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)