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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01928264
Other study ID # 114/13
Secondary ID
Status Terminated
Phase N/A
First received August 5, 2013
Last updated October 14, 2015
Start date August 2013
Est. completion date April 2014

Study information

Verified date October 2015
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

We will conduct a randomized control trial to investigate whether and to what extent regular and guided group physical activity over 12 weeks (2 sessions à 1 hour/week) improves physical fitness and (physio-)psychological functions (like subjective sleep, mental toughness, perceived stress, self-efficacy, etc.), as well as participation skills and the ability to work, in claimants for a disability pension due to psychiatric disorders, whose ability to work had recently been assessed by means of a psychiatric expert opinion. The control group is designed very similar and implies predominantly sedentary leisure time group activities (e.g. playing board games, doing handicrafts). Measures will be performed at baseline, post-test, and at follow ups three and twelve months after post-test, some variables will additionally be assessed 4-weekly during the intervention. We expect that intervention group participants will report and show, respectively, more improved physical fitness, (physio-)psychological functioning and participations skills, as well as increased ability to work, compared to the control group.


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Claimants for a disability pension due to a mental disorder, whose ability to work has been recently assessed by means of a psychiatric expert opinion

- Both genders

- 18-55 years old

- Clinical diagnosis of depressive disorder, somatoform disorder, anxiety disorder, personality disorder

- Sufficient competence in understanding, speaking and reading German

- Sufficient cognitive, emotional and social level of functioning to be able to participate in a group

- Physical Activity Readiness Questionnaire without evidence for reduction

- or: Physical activity readiness certificated by the general practitioner

- Informed consent

Exclusion Criteria:

- Comorbidity with a somatic disorder that limits the ability for physical exercises

- Pregnancy

- Ongoing disturbance of the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Physical activity


Locations

Country Name City State
Switzerland Psychiatric Hospital of the University of Basel Basel

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Institute for Exercise and Health Sciences, University of Basle, Switzerland, Psychiatric Hospital of the University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in physical fitness (VO2max = ml/kg/min) baseline and 15 months No
Other Change in physical fitness (VO2max = ml/kg/min) baseline and 6 months No
Other Change in physical fitness (VO2max = ml/kg/min) baseline and 12 weeks No
Other Change in physical fitness (VO2max = ml/kg/min) baseline and 8 weeks No
Other Change in physical fitness (VO2max = ml/kg/min) baseline and 4 weeks No
Other Change in perceived fitness (sum score) baseline and 15 months No
Other Change in perceived fitness (sum score) baseline and 6 months No
Other Change in perceived fitness (sum score) baseline and 12 weeks No
Other Change in perceived fitness (sum score) baseline and 8 weeks No
Other Change in perceived fitness (sum score) baseline and 4 weeks No
Primary Change in the ability to work (h/d / %) baseline and 15 months No
Secondary Change in the ability to work (h/d / %) baseline and 6 months No
Secondary Change in the ability to work (h/d / %) baseline and 12 weeks No
Secondary Change in participation skills (sum score) baseline and 15 months No
Secondary Change in participation skills (sum score) baseline and 6 months No
Secondary Change in participation skills (sum score) baseline and 12 weeks No
Secondary Change in psychological functioning (sum scores) baseline and 15 months No
Secondary Change in psychological functioning (sum scores) baseline and 6 months No
Secondary Change in psychological functioning (sum scores) baseline and 12 weeks No
Secondary Change in subjective sleep quality (sum score) baseline and 15 months No
Secondary Change in subjective sleep quality (sum score) baseline and 6 months No
Secondary Change in subjective sleep quality (sum score) baseline and 12 weeks No
Secondary Change in subjective sleep quality (sum score) baseline and 8 weeks No
Secondary Change in subjective sleep quality (sum score) baseline and 4 weeks No
Secondary Change in subjectively perceived stress (sum score) baseline and 15 months No
Secondary Change in subjectively perceived stress (sum score) baseline and 6 months No
Secondary Change in subjectively perceived stress (sum score) baseline and 12 weeks No
Secondary Change in subjectively perceived stress (sum score) baseline and 8 weeks No
Secondary Change in subjectively perceived stress (sum score) baseline and 4 weeks No
Secondary Change in Clinical Global Impression (sum score) baseline and 15 months No
Secondary Change in Clinical Global Impression (sum score) baseline and 6 months No
Secondary Change in Clinical Global Impression (sum score) baseline and 12 weeks No
Secondary Change in Leisure-time physical activity (sum score) baseline and 15 months No
Secondary Change in Leisure-time physical activity (sum score) baseline and 6 months No
Secondary Change in Leisure-time physical activity (sum score) baseline and 12 weeks No
Secondary Change in self-efficacy (sum score) baseline and 15 months No
Secondary Change in self-efficacy (sum score) baseline and 6 months No
Secondary Change in self-efficacy (sum score) baseline and 12 weeks No
Secondary Change in self-efficacy (sum score) baseline and 8 weeks No
Secondary Change in self-efficacy (sum score) baseline and 4 weeks No
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