Effects of a Walking Program in People With Mental Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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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).

Conditions
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Mental Disorders

Intervention / Treatment
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* Behavioral: 10-week walking program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Member of Psylos Medically approved by a physician

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br> <br> |
| No Intervention: Control group<br>Only receives measurements. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking Program, Mental Disorders, Physical Activity, Physical Fitness, Anxiety, Depression, Self Determination