Investigation of the Biopsychosocial Effectiveness of Different Exercise Trainings in Earthquake Survivors With Post-Traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with earthquake-related post-traumatic stress disorder (PTSD)
- •18-65 years old
- •Individuals who agree to participate in the study voluntarily
排除标准
- •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
结局指标
主要结局
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)
时间窗: 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)
时间窗: 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.
次要结局
- SF-36 Short Form(eight weeks)
- 6 Minute Walking Test(eight weeks)
- Post-Traumatic Stress Diagnostic Scale (PTSDS)(eight weeks)
- Impact of Events Scale-Revised (IES-R)(eight weeks)
- Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5)(eight weeks)
- Depression Anxiety and Stress Scale (DASS-21)(eight weeks)
- Pittsburgh Sleep Quality Index (PSQI)(eight weeks)
研究者
Erkin Oğuz SARI
Research Assistant
Hasan Kalyoncu University