Exercise in Anxiety and Posttraumatic Stress Disorders

NCT03758599 | Completed

• 1 other identifier: 256912
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Anxiety Disorder; Posttraumatic Stress Disorder; Sports intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Change from Baseline (t1) Depression at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)

  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)

  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)

  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)

  1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours

• Affective Responses_a

  1 minute before each intervention, after 38 minutes, after 75 minutes

Study Arms (3)

Climbing Exercise Group

EXPERIMENTAL

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

Aerobic Exercise Group

EXPERIMENTAL

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

Social Contact Control Group

ACTIVE COMPARATOR

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

Interventions

Climbing 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.

Climbing Exercise Group

Nordic Walking 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

Social Contact 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• acute psychosis or suicidal behaviour
• medical contraindication to physical activity (assessed by a clinician)
• cognitive deficits
• problems with German language

Sponsors & Collaborators

• Universitaet Innsbruck: lead
• Medical University Innsbruck: collaborator

Study Sites (1)

University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (1)

• 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.

  PMID: 35757205 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic

Interventions

Stair Climbing; Nordic Walking

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Barbara Sperner-Unterweger, Prof. MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: November 29, 2018
• Study Start: October 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)