Exercise in Anxiety and Posttraumatic Stress Disorders

NCT ID: NCT03758599

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2020-12-01

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)

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Climbing

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Nordic Walking

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Social Contact

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: collaborator

Universitaet Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Sperner-Unterweger, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Psychiatry II, Department of Psychiatry, Psychotherapy and Psychosomatics, Innsbruck Medical University

Locations

University of Innsbruck

Innsbruck, Tyrol, Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 35757205 (View on PubMed)

Other Identifiers

256912

Identifier Type: -

Identifier Source: org_study_id