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
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|
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 (Clinical Trial)|
|Actual Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Intervention group
|Behavioral: 10-week walking program|
No Intervention: Control group
Only receives measurements.
- Change in physical fitness pre - post [ Time Frame: baseline, 10 weeks ]Via 6 minute walk test.
- Change in physical fitness pre - follow-up [ Time Frame: baseline, 6 months ]Via 6 minute walk test.
- Change in physical activity pre - post [ Time Frame: baseline, 10 weeks ]Via a questionnaire.
- Change in physical activity pre - follow-up [ Time Frame: baseline, 6 months ]Via a questionnaire.
- Change in well-being pre - post [ Time Frame: baseline, 10 weeks ]Via a questionnaire.
- Change in well-being pre - follow-up [ Time Frame: baseline, 6 months ]Via a questionnaire.
- Change in psychosocial parameters pre - post [ Time Frame: baseline, 10 weeks ]Via a questionnaire.
- Change in psychosocial parameters pre - follow-up [ Time Frame: baseline, 6 months ]Via a questionnaire.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079012
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Filip Boen, Prof.||KU Leuven|