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Completed

NCT Number: NCT03758599

Exercise in Anxiety and Posttraumatic Stress Disorders

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change from Baseline (t1) Symptoms of Anxiety at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)

    Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours

    Beck Anxiety Inventory (BAI; Beck & Steer, 1990) The BAI ranges from 0 and 63 points with lower points indicating less symptoms of anxiety

  2. Change from Baseline (t1) Symptoms of Posttraumatic Stress Disorder at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)

    Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours

    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 outcomes

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

    Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours

    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.

  2. Change from Baseline (t1) Worry Symptoms at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)

    Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours

    Penn-State Worry Questionnaire (PSWQ; Meyer et al., 1990) The PSWQ ranges from 16 and 80 points with lower points indicating less worries.

  3. Change from Baseline (t1) Quality of Life (WHO) at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)

    Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours

    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.

  4. Change from Baseline (t1) Self Efficacy at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)

    Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours

    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.

  5. Affective Responses_a

    Time frame: 1 minute before each intervention, after 38 minutes, after 75 minutes

    Feeling Scale (FS; Hardy & Rejeski, 1989) The FS ranges from +5 to -5 points with lower points indicating low affective valence.

  6. Affective Responses_b

    Time frame: 1 minute before each intervention, after 38 minutes, after 75 minutes

    Felt Arousal Scale (FAS; Svebak & Murgatroyd, 1985) The FAS ranges from 1 to 6 points with lower points indicating low level of arousal.

  7. Affective Responses_c

    Time frame: 1 minute before each intervention, after 75 minutes

    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.

  8. Affective Responses_d

    Time frame: 38 minutes after beginning of intervention

    Rating of Perceived Exertion (RPE; Borg, 1998)

  9. Change from Baseline (t1) Analyses of neurotransmitter metabolites at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)

    Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours

    tryptophan-kynurenine and the phenylalanine-tyrosine pathways

  10. Change from Baseline (t1) Analyses of immune-activation markers at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)

    Time frame: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours

    neopterin and pro-inflammatory cytokines

Sponsors and collaborators

Lead sponsor

Universitaet Innsbruck

Other

Collaborators

  • Medical University Innsbruck

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2018
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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