Effects of a Walking Program in People With Mental Disorders

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).

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders
• Intervention / Treatment: Behavioral: 10-week walking program

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • KU Leuven

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical fitness pre - post	Via 6 minute walk test.	baseline, 10 weeks
Change in physical fitness pre - follow-up	Via 6 minute walk test.	baseline, 6 months
Change in physical activity pre - post	Via a questionnaire.	baseline, 10 weeks
Change in physical activity pre - follow-up	Via a questionnaire.	baseline, 6 months
Change in well-being pre - post	Via a questionnaire.	baseline, 10 weeks
Change in well-being pre - follow-up	Via a questionnaire.	baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in psychosocial parameters pre - post	Via a questionnaire.	baseline, 10 weeks
Change in psychosocial parameters pre - follow-up	Via a questionnaire.	baseline, 6 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg
• Investigators: Principal Investigator: Filip Boen, Prof., KU Leuven

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 28, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Depression; Physical Activity; Anxiety; Mental Disorders; Physical Fitness; Walking Program; Self Determination
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Disease; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: ML10148