Clinical trial NCT03758599: Exercise in Anxiety and Posttraumatic Stress Disorders
Official title: Exercise in Anxiety and Posttraumatic Stress Disorders - a Randomized Controlled Clinical Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety Disorder
Posttraumatic Stress Disorder
Sports intervention
Lead sponsor: Universitaet Innsbruck
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
First posted: 2018-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline (t1) Symptoms of Anxiety at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
timeFrame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
measure: Change from Baseline (t1) Symptoms of Posttraumatic Stress Disorder at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
timeFrame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Secondary outcomes:
measure: Change from Baseline (t1) Depression at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
timeFrame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
measure: Change from Baseline (t1) Worry Symptoms at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
timeFrame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
measure: Change from Baseline (t1) Quality of Life (WHO) at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
timeFrame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
measure: Change from Baseline (t1) Self Efficacy at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
timeFrame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
measure: Affective Responses_a
timeFrame: 1 minute before each intervention, after 38 minutes, after 75 minutes
measure: Affective Responses_b
timeFrame: 1 minute before each intervention, after 38 minutes, after 75 minutes
measure: Affective Responses_c
timeFrame: 1 minute before each intervention, after 75 minutes
measure: Affective Responses_d
timeFrame: 38 minutes after beginning of intervention
measure: Change from Baseline (t1) Analyses of neurotransmitter metabolites at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
timeFrame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
measure: Change from Baseline (t1) Analyses of immune-activation markers at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
timeFrame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: University of Innsbruck
state: Tyrol
Study officials:
affiliation: University Hospital of Psychiatry II, Department of Psychiatry, Psychotherapy and Psychosomatics, Innsbruck Medical University
name: Barbara Sperner-Unterweger, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bichler CS, Niedermeier M, Hufner K, Galffy M, Sperner-Unterweger B, Kopp M. Affective Responses to Both Climbing and Nordic Walking Exercise Are Associated With Intermediate-Term Increases in Physical Activity in Patients With Anxiety and Posttraumatic Stress Disorder - A Randomized Longitudinal Controlled Clinical Pilot Trial. Front Psychiatry. 2022 Jun 9;13:856730. doi: 10.3389/fpsyt.2022.856730. eCollection 2022.