NCT03758599

Exercise in Anxiety and Posttraumatic Stress Disorders

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Universitaet Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Anxiety

Interventions

Type	Name	Description
PROCEDURE	Climbing	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.
PROCEDURE	Nordic Walking	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.
PROCEDURE	Social Contact	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.

Timeline

• Start date: 2017-10-01
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2018-11-29
• Last updated: 2021-10-01

Locations

1 site across 1 country: Austria