ExerciseNCT03818425

Motivation and Barriers for Exercise in Patients With Anxiety or Posttraumatic Stress Disorder

An observational study of Exercise and Motivation, run by Universitaet Innsbruck at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Exercise, Motivation
How many people: 460 participants
Where: 1 siteAustria
Study dates: 7 Jan 2019to 30 Dec 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients of outpatient department and inpatients of the Medical Hospital Innsbruck, Department of Psychiatry and Psychosomatic will be selected by clinical professionals according to inclusion and exclusion criteria.

Who may be able to join

In- and out-patients with a diagnosed anxiety or posttraumatic stress disorder (F40, F41, F43.1; ICD-10)
18 to 65 years

Who cannot join

acute psychosis or suicidal behaviour
cognitive deficits
problems with German language

Trial locations and contacts

1 site in 1 country.

Austria1 site

University of Innsbruck
Innsbruck, Tyrol, 6020

Other trials in Austria

About this study

Relevance and Aim: There has been increasing research interest in sport preferences and motivational factors as well as barriers that restrain from engaging in sport activities in people suffering from mental illnesses. Anxiety disorders are one of the leading mental disorders worldwide. Exercise has previously shown anxiolytic effects and is discussed as an adjunctive treatment option in clinical practice. This study aims to depict motivation and barriers in patients with anxiety or posttraumatic stress disorders.

Design and Participants: Observational study of patients diagnosed with anxiety disorder or posttraumatic stress disorder (ICD-10)

Measurements: Structured questionnaire compounded of validated scales for current physical activity, sport motivation, exercise preferences, perceived barriers , self-efficacy, social support for physical activity, motivation,enjoyment, quality of life as well as sociodemographic data.

Duration: The questionnaire will require approximately 20 minutes, the overall duration is 3 months. Personal assistance for completing the questionnaire will be provided if necessary.

Conditions: Exercise, Motivation
Keywords: Anxiety, Posttraumatic Stress Disorder
Medical subject headings: Motor Activity, Anxiety Disorders, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03818425
Study group	Role	What they receive
Clinical Population		In- and Out-Patients diagnosed with depression (F32, F33), anxiety disorder (F40, F41; ICD-10) or posttraumatic stress disorder (F43.1; ICD-10)
Healthy Controls		Subjects with no previous or actual mental disorder

What is being measured

The primary outcome is the main question the study is designed to answer.

Physical activity
self reported, actual physical activity, measured by the International Physical Activity Questionnaire Short Form, IPAQ-SF; Craig et al., 2003
Measured: 5 minutes
Sport motivation
measured by the Exercise Motivation Inventory, EMI-2; Markland \& Hardy,1993
Measured: 5 minutes
Perceived barriers
measured by 12 questions referring to Ussher, Stanbury, Cheeseman \& Faulkner, 2007
Measured: 5 minutes
Self-efficacy for physical activity
single item question according to Ussher, Stanbury, Cheeseman \& Faulkner, 2007
Measured: 1 minute
Social support for physical activity
single item question according to Ussher, Stanbury, Cheeseman \& Faulkner, 2007
Measured: 1 minute
Motivation for physical activity
single item question according to Ussher, Stanbury, Cheeseman \& Faulkner, 2007
Measured: 1 minute
Enjoyment of physical activity
single item question according to Ussher, Stanbury, Cheeseman \& Faulkner, 2007
Measured: 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 201930 Dec 2019

First posted28 Jan 2019
Study start7 Jan 2019
Primary completion1 Oct 2019
Study completion30 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ExerciseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 460 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03818425
Sponsor's protocol ID: 256913
Status last verified: Mar 2020
First submitted: 24 Jan 2019
Last updated: 27 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bichler CS, Niedermeier M, Gufler A, Galffy M, Sperner-Unterweger B, Kopp M. A case-control study on physical activity preferences, motives, and barriers in patients with psychiatric conditions. Compr Psychiatry. 2021 Nov;111:152276. doi: 10.1016/j.comppsych.2021.152276. Epub 2021 Sep 23.
PubMed 34600310

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Motivation and Barriers for Exercise in Patients With Anxiety or Posttraumatic Stress Disorder
ClinicalTrials.gov ID: NCT03818425
Acronym / sponsor ID: 256913
Conditions: Exercise, Motivation
Keywords: Anxiety, Posttraumatic Stress Disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 460 participants (actual)
Lead sponsor: Universitaet InnsbruckUniversity, hospital or other
Collaborators: Medical University Innsbruck
Study start: 7 Jan 2019 (actual)
Primary completion: 1 Oct 2019 (actual)
Study completion: 30 Dec 2019 (actual)
First posted: 28 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Design and Participants: Observational study of patients diagnosed with anxiety disorder or posttraumatic stress disorder (ICD-10)

Duration: The questionnaire will require approximately 20 minutes, the overall duration is 3 months. Personal assistance for completing the questionnaire will be provided if necessary.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Clinical Population	–	–In- and Out-Patients diagnosed with depression (F32, F33), anxiety disorder (F40, F41; ICD-10) or posttraumatic stress disorder (F43.1; ICD-10)
Healthy Controls	–	–Subjects with no previous or actual mental disorder

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients of outpatient department and inpatients of the Medical Hospital Innsbruck, Department of Psychiatry and Psychosomatic will be selected by clinical professionals according to inclusion and exclusion criteria.

Key inclusion criteria (2 listed)

In- and out-patients with a diagnosed anxiety or posttraumatic stress disorder (F40, F41, F43.1; ICD-10)
18 to 65 years

Key exclusion criteria (3 listed)

acute psychosis or suicidal behaviour
cognitive deficits
problems with German language

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Physical activity
Time frame: 5 minutes
self reported, actual physical activity, measured by the International Physical Activity Questionnaire Short Form, IPAQ-SF; Craig et al., 2003
Sport motivation
Time frame: 5 minutes
measured by the Exercise Motivation Inventory, EMI-2; Markland \& Hardy,1993
Perceived barriers
Time frame: 5 minutes
measured by 12 questions referring to Ussher, Stanbury, Cheeseman \& Faulkner, 2007
Self-efficacy for physical activity
Time frame: 1 minute
single item question according to Ussher, Stanbury, Cheeseman \& Faulkner, 2007
Social support for physical activity
Time frame: 1 minute
single item question according to Ussher, Stanbury, Cheeseman \& Faulkner, 2007
Motivation for physical activity
Time frame: 1 minute
single item question according to Ussher, Stanbury, Cheeseman \& Faulkner, 2007
Enjoyment of physical activity
Time frame: 1 minute
single item question according to Ussher, Stanbury, Cheeseman \& Faulkner, 2007

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
Derived from this study: PubMed 34600310Bichler CS, Niedermeier M, Gufler A, Galffy M, Sperner-Unterweger B, Kopp M. A case-control study on physical activity preferences, motives, and barriers in patients with psychiatric conditions. Compr Psychiatry. 2021 Nov;111:152276. doi: 10.1016/j.comppsych.2021.152276. Epub 2021 Sep 23.
Individual participant dataSharing planned: No

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Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martin Kopp, PhD, Prof. study chair

Department of Sport Science, University of Innsbruck

Barbara Sperner-Unterweger, MD, Prof. study director

Department of Psychosomatics, Medical University of Innsbruck

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Exercise and Motivation, run by Universitaet Innsbruck at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity (time frame: 5 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03818425, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.