Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-04-25
Brief Title:
Biopsychosocial Effectiveness of Exercise Trainings in Earthquake Survivors With Post-Traumatic Stress Disorder
Sponsor:
Erkin Oğuz SARI
Organization:
Hasan Kalyoncu University
Study Overview
Official Title:
Investigation of the Biopsychosocial Effectiveness of Different Exercise Trainings in Earthquake Survivors With Post-Traumatic Stress Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 experiencechange 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
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 experiencechange 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None