Effects of a Walking Program in People With Mental Disorders

• ClinicalTrials.gov Identifier: NCT02079012
• Recruitment Status: Completed
• First Posted: March 5, 2014
• Last Update Posted: June 28, 2016
• Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg
• Information provided by (Responsible Party): Prof Filip Boen, Universitaire Ziekenhuizen Leuven

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mental Disorders	Behavioral: 10-week walking program	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 135 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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).
• Study Start Date: February 2014
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Behavioral: 10-week walking program
No Intervention: Control group; Only receives measurements.

Outcome Measures

Primary Outcome Measures :

1. Change in physical fitness pre - post [ Time Frame: baseline, 10 weeks ]
   Via 6 minute walk test.
2. Change in physical fitness pre - follow-up [ Time Frame: baseline, 6 months ]
   Via 6 minute walk test.
3. Change in physical activity pre - post [ Time Frame: baseline, 10 weeks ]
   Via a questionnaire.
4. Change in physical activity pre - follow-up [ Time Frame: baseline, 6 months ]
   Via a questionnaire.
5. Change in well-being pre - post [ Time Frame: baseline, 10 weeks ]
   Via a questionnaire.
6. Change in well-being pre - follow-up [ Time Frame: baseline, 6 months ]
   Via a questionnaire.

Secondary Outcome Measures :

1. Change in psychosocial parameters pre - post [ Time Frame: baseline, 10 weeks ]
   Via a questionnaire.
2. Change in psychosocial parameters pre - follow-up [ Time Frame: baseline, 6 months ]
   Via a questionnaire.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Locations

Belgium

KU Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg

Investigators

• Principal Investigator: Filip Boen, Prof.; KU Leuven

More Information

• Responsible Party: Prof Filip Boen, Doctor, Professor, Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT02079012
• Other Study ID Numbers: ML10148
• First Posted: March 5, 2014
• Last Update Posted: June 28, 2016
• Last Verified: June 2016

Keywords provided by Prof Filip Boen, Universitaire Ziekenhuizen Leuven:

Walking Program; Mental Disorders; Physical Activity; Physical Fitness; Anxiety; Depression; Self Determination

Additional relevant MeSH terms:

Disease; Mental Disorders; Psychotic Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders