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Clinical Trials/NCT02079012
NCT02079012CompletedNot Applicable

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 enrollmentStarted: February 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
135
Locations
1
Primary Endpoint
Change in physical fitness pre - post

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Intervention group

Experimental

Receives:

  • An information session
  • A 10-week walking program (with documents, pedometer and three information sessions about motivation, a healthy diet and smoking cessation)
  • A physical activity diary (which also functions as a tool to check protocol-compliance)
  • Measurements

Intervention: 10-week walking program (Behavioral)

Control group

No Intervention

Only receives measurements.

Outcomes

Primary Outcomes

Change in physical fitness pre - post

Time Frame: baseline, 10 weeks

Via 6 minute walk test.

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 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof Filip Boen

Doctor, Professor

Universitaire Ziekenhuizen KU Leuven

Study Sites (1)

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