Effects of a Walking Program in People With Mental Disorders

Mental Disorders Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079012
• Other study ID #: ML10148
• Status: Completed
• Phase: N/A
• First received: February 28, 2014
• Last updated: June 27, 2016
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years old

• Member of Psylos

• Medically approved by a physician

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• 10-week walking program

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical fitness pre - post	Via 6 minute walk test.	baseline, 10 weeks	No
Primary	Change in physical fitness pre - follow-up	Via 6 minute walk test.	baseline, 6 months	No
Primary	Change in physical activity pre - post	Via a questionnaire.	baseline, 10 weeks	No
Primary	Change in physical activity pre - follow-up	Via a questionnaire.	baseline, 6 months	No
Primary	Change in well-being pre - post	Via a questionnaire.	baseline, 10 weeks	No
Primary	Change in well-being pre - follow-up	Via a questionnaire.	baseline, 6 months	No
Secondary	Change in psychosocial parameters pre - post	Via a questionnaire.	baseline, 10 weeks	No
Secondary	Change in psychosocial parameters pre - follow-up	Via a questionnaire.	baseline, 6 months	No