- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03758599
Exercise in Anxiety and Posttraumatic Stress Disorders
Exercise in Anxiety and Posttraumatic Stress Disorders - a Randomized Controlled Clinical Pilot Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- University of Innsbruck
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Climbing Exercise Group
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.
|
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.
|
Experimental: Aerobic Exercise Group
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.
|
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.
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Active Comparator: Social Contact Control Group
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.
|
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.
|
What is the study measuring?
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)
Time Frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
|
Beck Anxiety Inventory (BAI; Beck & Steer, 1990) The BAI ranges from 0 and 63 points with lower points indicating less symptoms of anxiety
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1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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Change from Baseline (t1) Symptoms of Posttraumatic Stress Disorder at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time Frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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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
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1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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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)
Time Frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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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.
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1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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Change from Baseline (t1) Worry Symptoms at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time Frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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Penn-State Worry Questionnaire (PSWQ; Meyer et al., 1990) The PSWQ ranges from 16 and 80 points with lower points indicating less worries.
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1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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Change from Baseline (t1) Quality of Life (WHO) at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time Frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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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.
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1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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Change from Baseline (t1) Self Efficacy at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time Frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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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.
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1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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Affective Responses_a
Time Frame: 1 minute before each intervention, after 38 minutes, after 75 minutes
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Feeling Scale (FS; Hardy & Rejeski, 1989) The FS ranges from +5 to -5 points with lower points indicating low affective valence.
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1 minute before each intervention, after 38 minutes, after 75 minutes
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Affective Responses_b
Time Frame: 1 minute before each intervention, after 38 minutes, after 75 minutes
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Felt Arousal Scale (FAS; Svebak & Murgatroyd, 1985) The FAS ranges from 1 to 6 points with lower points indicating low level of arousal.
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1 minute before each intervention, after 38 minutes, after 75 minutes
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Affective Responses_c
Time Frame: 1 minute before each intervention, after 75 minutes
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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.
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1 minute before each intervention, after 75 minutes
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Affective Responses_d
Time Frame: 38 minutes after beginning of intervention
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Rating of Perceived Exertion (RPE; Borg, 1998)
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38 minutes after beginning of intervention
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Change from Baseline (t1) Analyses of neurotransmitter metabolites at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time Frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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tryptophan-kynurenine and the phenylalanine-tyrosine pathways
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1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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Change from Baseline (t1) Analyses of immune-activation markers at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Time Frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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neopterin and pro-inflammatory cytokines
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1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Barbara Sperner-Unterweger, Prof. MD, University Hospital of Psychiatry II, Department of Psychiatry, Psychotherapy and Psychosomatics, Innsbruck Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 256912
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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