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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00014280 |
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Date of registration:
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15/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The impact of an exercise training intervention on cortisol levels and Post-Traumatic Stress Disorder in Congolese refugees: Study protocol for a randomized control trial
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Scientific title:
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The impact of an exercise training intervention on cortisol levels and Post-Traumatic Stress Disorder in Congolese refugees: Study protocol for a randomized control trial |
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Date of first enrolment:
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20/01/2019 |
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Target sample size:
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198 |
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Recruitment status: |
Pending |
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URL:
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http://drks.de/search/en/trial/DRKS00014280 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active//No treatment / Standard of care; Assignment: parallel; Study design purpose: treatment
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Phase:
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3
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Henning
Budde |
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Address:
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Am Kaiserkai 1
20457
Hamburg
Germany |
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Telephone:
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0049 4036122640 |
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Email:
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henning.budde@medicalschool-hamburg.de |
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Affiliation:
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MSH Medical School Hamburg |
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Name:
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Davin Patrick
Akko |
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Address:
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Am Kaiserkai 1
20457
Hamburg
Germany |
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Telephone:
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017683304643 |
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Email:
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davin.akko@gmail.com |
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Affiliation:
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MSH Medical School Hamburg |
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Key inclusion & exclusion criteria
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Inclusion criteria: Participants eligible for inclusion in the intervention only involve individuals with a diagnosis of PTSD according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V).
Exclusion criteria: Exclusion criteria covers 1) acute suicidality, acute intoxication, or psychotic symptoms, 2) inability of the parent or legal guardian to provide consent, or 3) child protection issues (e.g., acute maltreatment) that are identified during the initial cross- sectional assessment and judged by a clinician to make trial inclusion inappropriate. Additionally, the participants may not be part of any other psychological therapy or take any medication with psychoactive drugs until the study is completed. We further control for an unchanged physical activity level during the intervention.
Age minimum:
13 Years
Age maximum:
16 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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F43.1
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Post-traumatic stress disorder
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F43.1
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Intervention(s)
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Group 1: Exercise Training Group (ETG)
The participants in the Exercise Training Group will attend three exercise sessions every week for a total number of eight weeks. That makes this training a chronic exercise intervention [10]. Every unit takes 45 minutes. Two local and experienced trainers from Uganda instruct identical classes of 25-35 participants. Each session will be performed with high intensity with a HFmax of 70-85%. In our preliminary work, significant cortisol and testosterone increases were found by implementing an acute exercise of 70-85% Hfmax, but not with 50-65% HFmax [24]. The training program will focus on improvement of cardiovascular fitness through running and running-based games of moderate to vigorous intensity (recorded on three occasions by F1 Polar HR monitors; Polar, Kempele, Finland) [46].
Group 2: Alternative Intervention Group (AIG)
The participants will attend three 45-minute sessions a week for a total number of eight weeks. The training of the AIG will consist of very little strain, light stretching, and simple exercises that target posture and balance [48] as well as fine and gross motor body coordination through playful balance, bilateral coordination, hand-eye coordination, and leg-arm coordination exercises [46]. These sessions will also be conducted in a group setting, by local and experienced trainers. The HFmax levels will be monitored the same way as in the ETG.
Group 3: Waiting-list Control Group (WCG)
No specific intervention will be implemented. However, the exercise training intervention will be done with this group after the end of the measurement (t4).
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Primary Outcome(s)
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Psychological disorders
The Mini International Neuropsychiatric Interview - Kid 7.0.2 (M.I.N.I.; [50]) represents a shortened psychiatric interview on the basis of DSM-V in order to help clinicians diagnose and evaluate the major psychiatric disorders. The test takes about 15-20 minutes and is performed in form of a standardized interview. The M.I.N.I. will help to identify acute co-morbid diseases relevant for eligibility of the participants. It will be used at t0 "Eligibility".
Trauma
The UCLA Child/Adolescent PTSD Reaction Index for DSM-5 (UCLA; [49]) is a screening tool recommended by the National Center for PTSD to collect data about the kind of traumatic happening the participants experienced. It is a 24-item questionnaire assessed to DSM-V criteria for PTSD and will be used at t1 "Baseline"
For the more in-depth baseline PTSD assessment, the Clinical Administered PTSD Scale for DSM-5 Child/Adolescent Version (CAPS-CA-5; [51]) will be applied. The CAPS-CA-5 is a 30-item structured interview for the assessment of PTSD based on DSM-5 criteria. The interview will take about 45-60 minutes and is considered the gold standard for assessing PTSD severity. The CAPS-CA-5 has excellent psychometric properties and has already been successfully administered in other East-African samples [52]. It will serve as the main psychological outcome variable and will be collected at
t1 Baseline, t1b Interim-test, t2 Post-test, t3 3-month follow up, and t4 6-month follow up
Physical performance
In the Shuttle Run Test the participants have to run alternately between two lines that are 20 meters separated from each other. The running speed will be given by intervals between tone signals. The interval between those signals will be reduced at every level. At the beginning of the test, the running speed is 8 km/h. Every minute it will increase by 0.5km/h. One minute is roughly equivalent to one level of the shuttle run test. Every time the acoustic hint sounds, the participants have to reach the line. When a subject does not reach the line twice in a row, the test will be over for them. The graduated mileage will be noted and the appropriate VO2max level can be read off, as described from Budde et al. (2010)[24]. The International Physical Activity Questionnaire - Short Form (IPAQ-SF; [57]) captures the general physical activity level of individuals by calculating the time of moderate and vigorous physical activity as well as the time the participants spend walking and sitting. The questionnaire had also been used in African context [58] and refers to the last seven days. Both tests will be carried out at following time points: t1 Baseline, t1b Interim-test, t2 Post-test, t3 3-month follow up, and t4 6-month follow up.
Hormonal Analysis
The determination of the cortisol awakening response (CAR) will take place in following six samples:
1. Sample 1 “awakening” in the morning as soon as the participants wake up.
2. Sample 2 “post-awakening I” 30minutes after taking awakening sample.
3. Sample 3 “post-awakening II” 45minutes after taking awakening sample.
4. Sample 4 “post-awakening III” 60minutes after taking awakening sample.
5. Sample 5 “post-awakening IV” at 0900h, collected in the school.
6. Sample 6 “post-awakening V” at 1100h, collected in the school.
Additionally, DHEA levels will be contained at Sample 1, Sample 2, and Sample 3 only.
For more information see table 1.
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Secondary Outcome(s)
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The adapted Version of the Patient Health Questionnaire (PHQ-A; [53]) for the
use in adolescent samples will be used as a measure to assess the participants’ depressive symptomatology. It is a brief 9-item measure that assesses clinically significant symptoms of depressive disorders and episodes in children ages 11-17.
The Strengths and Difficulties Questionnaire (SDQ; [54]) is a brief behavioral screening questionnaire that can serve to identify psychosocial, emotional, and behavioral problems. It is a widely used 25-item measure that has shown its usefulness in various studies and different populations with mental health problems.
The Psychlops [55] is a client-generated outcome measure for the assessment of the main psychological problem from the patients’ perspective. It is designed to measure longitudinal changes over the course of an intervention and provides different questions for the baseline, the interim, and the follow-up assessments. In this study, it will also help to capture the most significant mental health problems beyond the diagnoses specific approach.
The body mass index will also be calculated by taking the body weight in kilograms and dividing it by the height [59].
The total body fat will be determined by using a skinfold caliper.
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Source(s) of Monetary Support
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Deutsche Forschungsgemeinschaft (DFG)
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Ethics review
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Status: Approved
Approval date: 06/02/2018
Contact:
Ethikkommission@medicalschool-hamburg.de
Ethik-Kommission der MSH Medical School Hamburg
040231226477
Ethikkommission@medicalschool-hamburg.de
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