Effects of a Walking Program in People With Mental Disorders
Primary Purpose
Mental Disorders
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
10-week walking program
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorders focused on measuring Walking Program, Mental Disorders, Physical Activity, Physical Fitness, Anxiety, Depression, Self Determination
Eligibility Criteria
Inclusion Criteria:
- At least 18 years old
- Member of Psylos
- Medically approved by a physician
Sites / Locations
- KU Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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
Only receives measurements.
Outcomes
Primary Outcome Measures
Change in physical fitness pre - post
Via 6 minute walk test.
Change in physical fitness pre - follow-up
Via 6 minute walk test.
Change in physical activity pre - post
Via a questionnaire.
Change in physical activity pre - follow-up
Via a questionnaire.
Change in well-being pre - post
Via a questionnaire.
Change in well-being pre - follow-up
Via a questionnaire.
Secondary Outcome Measures
Change in psychosocial parameters pre - post
Via a questionnaire.
Change in psychosocial parameters pre - follow-up
Via a questionnaire.
Full Information
NCT ID
NCT02079012
First Posted
February 28, 2014
Last Updated
June 27, 2016
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg
1. Study Identification
Unique Protocol Identification Number
NCT02079012
Brief Title
Effects of a Walking Program in People With Mental Disorders
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 Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Walking Program, Mental Disorders, Physical Activity, Physical Fitness, Anxiety, Depression, Self Determination
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Only receives measurements.
Intervention Type
Behavioral
Intervention Name(s)
10-week walking program
Primary Outcome Measure Information:
Title
Change in physical fitness pre - post
Description
Via 6 minute walk test.
Time Frame
baseline, 10 weeks
Title
Change in physical fitness pre - follow-up
Description
Via 6 minute walk test.
Time Frame
baseline, 6 months
Title
Change in physical activity pre - post
Description
Via a questionnaire.
Time Frame
baseline, 10 weeks
Title
Change in physical activity pre - follow-up
Description
Via a questionnaire.
Time Frame
baseline, 6 months
Title
Change in well-being pre - post
Description
Via a questionnaire.
Time Frame
baseline, 10 weeks
Title
Change in well-being pre - follow-up
Description
Via a questionnaire.
Time Frame
baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in psychosocial parameters pre - post
Description
Via a questionnaire.
Time Frame
baseline, 10 weeks
Title
Change in psychosocial parameters pre - follow-up
Description
Via a questionnaire.
Time Frame
baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years old
Member of Psylos
Medically approved by a physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip Boen, Prof.
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
KU Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
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Effects of a Walking Program in People With Mental Disorders
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