Skip to main content
OpenTrials
Completed

NCT Number: NCT02079012

Effects of a Walking Program in People With Mental Disorders

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

10-week walking program

Behavioral

Primary outcomes

  1. Change in physical fitness pre - post

    Time frame: baseline, 10 weeks

    Via 6 minute walk test.

  2. Change in physical fitness pre - follow-up

    Time frame: baseline, 6 months

    Via 6 minute walk test.

  3. Change in physical activity pre - post

    Time frame: baseline, 10 weeks

    Via a questionnaire.

  4. Change in physical activity pre - follow-up

    Time frame: baseline, 6 months

    Via a questionnaire.

  5. Change in well-being pre - post

    Time frame: baseline, 10 weeks

    Via a questionnaire.

  6. Change in well-being pre - follow-up

    Time frame: baseline, 6 months

    Via a questionnaire.

Secondary outcomes

  1. Change in psychosocial parameters pre - post

    Time frame: baseline, 10 weeks

    Via a questionnaire.

  2. Change in psychosocial parameters pre - follow-up

    Time frame: baseline, 6 months

    Via a questionnaire.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg

Registry information

Official study 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).

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2014
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.