Clinical trial NCT02079012: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: Walking Program
Mental Disorders
Physical Activity
Physical Fitness
Anxiety
Depression
Self Determination
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg
First posted: 2014-03-05
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Member of Psylos
* Medically approved by a physician

Primary outcomes:
measure: Change in physical fitness pre - post
timeFrame: baseline, 10 weeks
measure: Change in physical fitness pre - follow-up
timeFrame: baseline, 6 months
measure: Change in physical activity pre - post
timeFrame: baseline, 10 weeks
measure: Change in physical activity pre - follow-up
timeFrame: baseline, 6 months
measure: Change in well-being pre - post
timeFrame: baseline, 10 weeks
measure: Change in well-being pre - follow-up
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Change in psychosocial parameters pre - post
timeFrame: baseline, 10 weeks
measure: Change in psychosocial parameters pre - follow-up
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Filip Boen, Prof.
role: PRINCIPAL_INVESTIGATOR
References: