Effects of a Walking Program in People With Mental Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Universitaire Ziekenhuizen Leuven
Sponsor:
Collaborator:
Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg
Information provided by (Responsible Party):
Prof Filip Boen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT02079012
First received: February 28, 2014
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 Intervention
Mental Disorders
Behavioral: 10-week walking program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Change in physical fitness pre - post [ Time Frame: baseline, 10 weeks ] [ Designated as safety issue: No ]
    Via 6 minute walk test.

  • Change in physical fitness pre - follow-up [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Via 6 minute walk test.

  • Change in physical activity pre - post [ Time Frame: baseline, 10 weeks ] [ Designated as safety issue: No ]
    Via a questionnaire.

  • Change in physical activity pre - follow-up [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Via a questionnaire.

  • Change in well-being pre - post [ Time Frame: baseline, 10 weeks ] [ Designated as safety issue: No ]
    Via a questionnaire.

  • Change in well-being pre - follow-up [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Via a questionnaire.


Secondary Outcome Measures:
  • Change in psychosocial parameters pre - post [ Time Frame: baseline, 10 weeks ] [ Designated as safety issue: No ]
    Via a questionnaire.

  • Change in psychosocial parameters pre - follow-up [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Via a questionnaire.


Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group

Receives:

  • An information session
  • A 10-week walking program (with documents, pedometer and three information sessions about motivation, a healthy diet and smoking cessation)
  • A physical activity diary (which also functions as a tool to check protocol-compliance)
  • Measurements
Behavioral: 10-week walking program
No Intervention: Control group
Only receives measurements.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Member of Psylos
  • Medically approved by a physician
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02079012

Contacts
Contact: Jari Vanroy, Drs. +32470574802 jari.vanroy@faber.kuleuven.be

Locations
Belgium
KU Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Jari Vanroy, Drs.    +32470574802    jari.vanroy@faber.kuleuven.be   
Principal Investigator: Filip Boen, Prof.         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg
Investigators
Principal Investigator: Filip Boen, Prof. KU Leuven
  More Information

No publications provided

Responsible Party: Prof Filip Boen, Doctor, Professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02079012     History of Changes
Other Study ID Numbers: ML10148
Study First Received: February 28, 2014
Last Updated: May 20, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Walking Program
Mental Disorders
Physical Activity
Physical Fitness
Anxiety
Depression
Self Determination

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 31, 2014