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

June 13, 2024 updated by: Erkin Oğuz SARI

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Gaziantep, Turkey
        • Hasan Kalyoncu University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals diagnosed with earthquake-related post-traumatic stress disorder (PTSD)
  • 18-65 years old
  • Individuals who agree to participate in the study voluntarily

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: 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.
Active Comparator: 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.
Other: 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 Names:
  • Cognitive Exercise Therapy Approach (BETY)
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
eight weeks
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.
eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minute Walking Test
Time Frame: eight weeks

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.
eight weeks
Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5)
Time Frame: eight weeks

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).
eight weeks
Impact of Events Scale-Revised (IES-R)
Time Frame: eight weeks

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.
eight weeks
Depression Anxiety and Stress Scale (DASS-21)
Time Frame: eight weeks

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.
eight weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: eight weeks

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.
eight weeks
SF-36 Short Form
Time Frame: eight weeks

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.
eight weeks
Post-Traumatic Stress Diagnostic Scale (PTSDS)
Time Frame: eight weeks
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.
eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erkin Oğuz SARI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 25, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKU-FTR-EOS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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