Effects of a Walking Program in People With Mental Disorders
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02079012 |
Recruitment Status :
Completed
First Posted : March 5, 2014
Last Update Posted : June 28, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Intervention group
Receives:
|
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 18 years old
- Member of Psylos
- Medically approved by a physician

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079012
Belgium | |
KU Leuven | |
Leuven, Vlaams-Brabant, Belgium, 3000 |
Principal Investigator: | Filip Boen, Prof. | KU Leuven |
Responsible Party: | Prof Filip Boen, Doctor, Professor, Universitaire Ziekenhuizen Leuven |
ClinicalTrials.gov Identifier: | NCT02079012 |
Other Study ID Numbers: |
ML10148 |
First Posted: | March 5, 2014 Key Record Dates |
Last Update Posted: | June 28, 2016 |
Last Verified: | June 2016 |
Walking Program Mental Disorders Physical Activity Physical Fitness |
Anxiety Depression Self Determination |
Disease Mental Disorders Psychotic Disorders Pathologic Processes Schizophrenia Spectrum and Other Psychotic Disorders |