Effects of a Walking Program in People With Mental Disorders

NCT ID: NCT02079012

Last Updated: 2016-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-06-30

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.

Conditions

Mental Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

10-week walking program

Intervention Type: BEHAVIORAL

Control group

Only receives measurements.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

10-week walking program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg

UNKNOWN

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Prof Filip Boen

Doctor, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filip Boen, Prof.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

KU Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

ML10148

Identifier Type: -

Identifier Source: org_study_id