Exercise in Anxiety and Posttraumatic Stress Disorders

Study Overview
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Brief Summary
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Aim: Aerobic and resistance exercise showed anxiolytic effects in clinical populations. Climbing could further enhance self-efficacy. Aim of the study is to examine whether climbing exercise and aerobic exercise, compared to social contact control, reduces symptoms of disease in out-patients with anxiety disorder (AD) and post-traumatic stress disorder (PTSD). Further analyses are aiming to reveal differences between climbing - and aerobic exercise. Design: Randomized controlled clinical trial Participants: Thirty out-patients diagnosed with International Classification of Disease-Version 10 (ICD-10) (F40, F41, F43.1) for AD or PTSD. Intervention: Out-patients will be assigned randomly to a climbing exercise group (a), aerobic exercise group (Nordic walking) (b) or social contact control group (c). Measurements: Primary outcome is symptom severity in AD or Post Traumatic Stress Disorders. Further secondary outcomes are evaluated by psychological questionnaires assessing depression, worry symptoms, quality of life, self-efficacy and affective responses. Metabolites of neurotransmitters, immune-activation markers and anthropometric data will be additionally provided as secondary physiological outcomes. Duration: Intervention duration is four weeks with 2 x 75 min for every group (climbing exercise, aerobic exercise, social contact control). Measurement points are set at the beginning (t1), at the end of the intervention (t2) and 3 (t3) and 6 (t4) months follow-up.

Detailed Description
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The proposed research project is designed as a randomized controlled clinical trial with three arms. The efficacy of a climbing exercise program, an aerobic exercise program and a social contact control group on primary and secondary study outcome will be investigated (see Figure 1). Patients will be first screened by the outpatient-unit of the Department of Psychosomatics at the Medical University of Innsbruck or remitted through the treating staff network community. When assessed as eligible for the study, a group of up to ten out-patients will be randomly selected and invited to an informative meeting. Patients receive study information and time tables for their group attendances. The intervention will start within the following week and will end four weeks after beginning. Follow-up assessments will take place three and six months after intervention. In addition to the AD/PTSD symptom screening, secondary study outcomes will be assessed: at study inclusion (t1) at the end of the intervention (t2) three months after the intervention (t3) six months after the intervention (t4)

Official Title
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Exercise in Anxiety and Posttraumatic Stress Disorders - a Randomized Controlled Clinical Pilot Trial

Conditions
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Anxiety

Intervention / Treatment
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* Procedure: Climbing
* Procedure: Nordic Walking
* Procedure: Social Contact


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICD-10 diagnosis of Anxiety Disorder or Post Traumatic Stress Disorder: F40, F41, F43.1; age range: 18-65 written informed consent stable medication (if needed) for at least 3 weeks Exclusion Criteria: acute psychosis or suicidal behaviour medical contraindication to physical activity (assessed by a clinician) cognitive deficits problems with German language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial with three arms for the comparison of the efficacy of a climbing exercise program, an aerobic exercise program and a social contact control group on symptoms of AD/PTSD, worry symptoms, quality of life, physical activity, health-related resources and affective responses in patients with AD or PTSD.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Climbing Exercise Group<br>At the beginning of each session, a standardized body-centered, mind-setting warmup of ten minutes will take place. The general warm-up will be followed by climbing specific warm-up, which will consist of bouldering (20-30 minutes). Afterwards the rope climbing session will start. Climbing sessions also contain several sport-specific skill-development training sessions to familiarize the participants with gear and rope management, to acquire footwork and route finding, and to locate good belay spots and resting positions while climbing. At the end of the climbing session a short cool-down of five minutes will be executed. | Procedure: Climbing<br>* All interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates.<br>|
| Experimental: Aerobic Exercise Group<br>As the climbing exercise group, the aerobic exercise group will start with a ten minutes body-centered, mind-setting warm-up, followed by 60 minutes of Nordic walking and five minutes cool down. A physiotherapist or sport scientist will instruct and guide the group. Nordic walking will be performed at a moderate pace at varying paths. | Procedure: Nordic Walking<br>* All interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates.<br>|
| Active Comparator: Social Contact Control Group<br>Patients allocated to the social contact control group will receive the same amount of social interaction as the exercise groups. A physiotherapist or sport scientist will be present while participants watch movies with relevant content to disease followed by interactive group discussions. This group is required to control for the impact of social contact/support on AD/PTSD and secondary outcomes. | Procedure: Social Contact<br>* All interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline (t1) Symptoms of Anxiety at four weeks (t2), three months after intervention (t3) and six months after intervention (t4) | Beck Anxiety Inventory (BAI; Beck & Steer, 1990) The BAI ranges from 0 and 63 points with lower points indicating less symptoms of anxiety | 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours | 
| Change from Baseline (t1) Symptoms of Posttraumatic Stress Disorder at four weeks (t2), three months after intervention (t3) and six months after intervention (t4) | Post Traumatic Stress Disorder Checklist Civil Version (PCL-5; Weathers et al., 2013) The PCL-5 ranges from 0 and 80 points with lower points indicating less symptoms of PTSD The PCL-5 ranges from 0 and 80 points with lower points indicating less symptoms of Posttraumatic Stress Disorder | 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline (t1) Depression at four weeks (t2), three months after intervention (t3) and six months after intervention (t4) | Beck Depression Inventory (BDI-II; Beck et al., 1996) The BDI-II ranges from 0 and 63 points with lower points indicating less symptoms of depression. | 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours | 
| Change from Baseline (t1) Worry Symptoms at four weeks (t2), three months after intervention (t3) and six months after intervention (t4) | Penn-State Worry Questionnaire (PSWQ; Meyer et al., 1990) The PSWQ ranges from 16 and 80 points with lower points indicating less worries. | 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours | 
| Change from Baseline (t1) Quality of Life (WHO) at four weeks (t2), three months after intervention (t3) and six months after intervention (t4) | Quality of life (WHOQOL-BREF; WHOQOL Group, 1998) The WHOQOL-BREF ranges from 5 and 130 points with lower points indicating less quality of life. | 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours | 
| Change from Baseline (t1) Self Efficacy at four weeks (t2), three months after intervention (t3) and six months after intervention (t4) | General Self-Efficacy Scale (GSE; Schwarzer & Jerusalem, 1995) The GSE ranges from 4 and 40 points with lower points indicating less resources in self efficacy. | 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours | 
| Affective Responses_a | Feeling Scale (FS; Hardy & Rejeski, 1989) The FS ranges from +5 to -5 points with lower points indicating low affective valence. | 1 minute before each intervention, after 38 minutes, after 75 minutes | 
| Affective Responses_b | Felt Arousal Scale (FAS; Svebak & Murgatroyd, 1985) The FAS ranges from 1 to 6 points with lower points indicating low level of arousal. | 1 minute before each intervention, after 38 minutes, after 75 minutes | 
| Affective Responses_c | The Positive and Negative Affect Scale (PANAS; Watson, Clark, & Tellegen, 1988) The PANAS measures two subscales, positive affect (points ranging from 10 to 50) and negative affect (points ranging from 10 to 50) Lower points on positive subscale indicates low level of positive affect, low points on negative affect subscale indicates low level of negative affect. | 1 minute before each intervention, after 75 minutes | 
| Affective Responses_d | Rating of Perceived Exertion (RPE; Borg, 1998) | 38 minutes after beginning of intervention | 
| Change from Baseline (t1) Analyses of neurotransmitter metabolites at four weeks (t2), three months after intervention (t3) and six months after intervention (t4) | tryptophan-kynurenine and the phenylalanine-tyrosine pathways | 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours | 
| Change from Baseline (t1) Analyses of immune-activation markers at four weeks (t2), three months after intervention (t3) and six months after intervention (t4) | neopterin and pro-inflammatory cytokines | 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety Disorder, Posttraumatic Stress Disorder, Sports intervention