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Exercise in Anxiety and Posttraumatic Stress Disorders

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Climbing
Nordic Walking
Social Contact
Sponsored by
Universitaet Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety Disorder, Posttraumatic Stress Disorder, Sports intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Innsbruck

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Climbing Exercise Group

Aerobic Exercise Group

Social Contact Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change from Baseline (t1) Depression at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
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.
Change from Baseline (t1) Worry Symptoms at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Penn-State Worry Questionnaire (PSWQ; Meyer et al., 1990) The PSWQ ranges from 16 and 80 points with lower points indicating less worries.
Change from Baseline (t1) Quality of Life (WHO) at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
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.
Change from Baseline (t1) Self Efficacy at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
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.
Affective Responses_a
Feeling Scale (FS; Hardy & Rejeski, 1989) The FS ranges from +5 to -5 points with lower points indicating low affective valence.
Affective Responses_b
Felt Arousal Scale (FAS; Svebak & Murgatroyd, 1985) The FAS ranges from 1 to 6 points with lower points indicating low level of arousal.
Affective Responses_c
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.
Affective Responses_d
Rating of Perceived Exertion (RPE; Borg, 1998)
Change from Baseline (t1) Analyses of neurotransmitter metabolites at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
tryptophan-kynurenine and the phenylalanine-tyrosine pathways
Change from Baseline (t1) Analyses of immune-activation markers at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
neopterin and pro-inflammatory cytokines

Full Information

First Posted
October 11, 2018
Last Updated
September 29, 2021
Sponsor
Universitaet Innsbruck
Collaborators
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT03758599
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaet Innsbruck
Collaborators
Medical University Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety Disorder, Posttraumatic Stress Disorder, Sports intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Climbing Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerobic Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Social Contact Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Climbing
Intervention Description
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
Intervention Name(s)
Nordic Walking
Intervention Description
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
Intervention Name(s)
Social Contact
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline (t1) Symptoms of Anxiety at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Description
Beck Anxiety Inventory (BAI; Beck & Steer, 1990) The BAI ranges from 0 and 63 points with lower points indicating less symptoms of anxiety
Time Frame
1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Title
Change from Baseline (t1) Symptoms of Posttraumatic Stress Disorder at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Description
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
Time Frame
1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Secondary Outcome Measure Information:
Title
Change from Baseline (t1) Depression at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Description
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.
Time Frame
1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Title
Change from Baseline (t1) Worry Symptoms at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Description
Penn-State Worry Questionnaire (PSWQ; Meyer et al., 1990) The PSWQ ranges from 16 and 80 points with lower points indicating less worries.
Time Frame
1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Title
Change from Baseline (t1) Quality of Life (WHO) at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Description
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.
Time Frame
1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Title
Change from Baseline (t1) Self Efficacy at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Description
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.
Time Frame
1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Title
Affective Responses_a
Description
Feeling Scale (FS; Hardy & Rejeski, 1989) The FS ranges from +5 to -5 points with lower points indicating low affective valence.
Time Frame
1 minute before each intervention, after 38 minutes, after 75 minutes
Title
Affective Responses_b
Description
Felt Arousal Scale (FAS; Svebak & Murgatroyd, 1985) The FAS ranges from 1 to 6 points with lower points indicating low level of arousal.
Time Frame
1 minute before each intervention, after 38 minutes, after 75 minutes
Title
Affective Responses_c
Description
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.
Time Frame
1 minute before each intervention, after 75 minutes
Title
Affective Responses_d
Description
Rating of Perceived Exertion (RPE; Borg, 1998)
Time Frame
38 minutes after beginning of intervention
Title
Change from Baseline (t1) Analyses of neurotransmitter metabolites at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Description
tryptophan-kynurenine and the phenylalanine-tyrosine pathways
Time Frame
1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Title
Change from Baseline (t1) Analyses of immune-activation markers at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
Description
neopterin and pro-inflammatory cytokines
Time Frame
1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Sperner-Unterweger, Prof. MD
Organizational Affiliation
University Hospital of Psychiatry II, Department of Psychiatry, Psychotherapy and Psychosomatics, Innsbruck Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35757205
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.
Results Reference
derived

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Exercise in Anxiety and Posttraumatic Stress Disorders

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