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Clinical Trials/NCT02079012
NCT02079012
Completed
N/A

Short- and Long-term Effects of a Walking Program ("Join the Walk?") on Physical Activity, Physical Fitness and Subjective Well-Being With Members of a Sports Federation for People With Mental Disorders (Psylos).

Universitaire Ziekenhuizen KU Leuven1 site in 1 country135 target enrollmentFebruary 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Disorders
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
135
Locations
1
Primary Endpoint
Change in well-being pre - post
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to investigate the short- and long-term effects of a 10-week walking program, based on the self-determination theory, in people with mental disorders. The investigators expect positive effects on:

  • Physical fitness
  • Physical activity
  • Well-being (less feelings of anxiety, less feelings of depression) The investigators also expect underlying psychosocial processes to influence these effects.

Detailed Description

Framework: Previous research has shown beneficial health effects of a 10-week walking program in a senior organisation. Based upon the self-determination theory, similar results can be expected in people with mental disorders and could be highly relevant, given the fact that these people: * Are often less active * Have mental problems and often also comorbidities * Are often socially isolated Participants: Psylos tries to recruit a convenience sample of at least 100 participants for an intervention group (which will undertake the walking program) and 80 participants for a control group. All of them have to sign an informed consent. Due to attrition, at least 60 participants in the intervention group and 40 in the control group can be expected. A post hoc analysis, with detailed information about the variation in this population, may give additional information about the necessary power to obtain significant results. Data analysis: First there will be examined whether the participants in both groups are equal at baseline according to relevant parameters (due to the non-randomisation). Second, to test the main effects, the difference scores will be examined between both groups. If certain assumptions are met, by an unpaired t-test; if not, by a non-parametric test. Finally (if relevant), the underlying psychosocial processes will be examined by regression analyses.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof Filip Boen

Doctor, Professor

Universitaire Ziekenhuizen KU Leuven

Eligibility Criteria

Inclusion Criteria

  • At least 18 years old
  • Member of Psylos
  • Medically approved by a physician

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in well-being pre - post

Time Frame: baseline, 10 weeks

Via a questionnaire.

Change in physical fitness pre - follow-up

Time Frame: baseline, 6 months

Via 6 minute walk test.

Change in physical activity pre - post

Time Frame: baseline, 10 weeks

Via a questionnaire.

Change in physical fitness pre - post

Time Frame: baseline, 10 weeks

Via 6 minute walk test.

Change in physical activity pre - follow-up

Time Frame: baseline, 6 months

Via a questionnaire.

Change in well-being pre - follow-up

Time Frame: baseline, 6 months

Via a questionnaire.

Secondary Outcomes

  • Change in psychosocial parameters pre - post(baseline, 10 weeks)
  • Change in psychosocial parameters pre - follow-up(baseline, 6 months)

Study Sites (1)

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