Mental DisordersNCT02079012
Effects of a Walking Program in People With Mental Disorders
A study testing 10-week walking program in people with Mental Disorders, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- 10-week walking program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Member of Psylos
- Medically approved by a physician
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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).
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.
Read the 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.
- Conditions
- Mental Disorders
- Being tested
- 10-week walking program
- Keywords
- Walking Program, Mental Disorders, Physical Activity, Physical Fitness, Anxiety, Depression, Self Determination
- Medical subject headings
- Mental Disorders, Motor Activity, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-week walking programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Behavioral: 10-week walking program |
| Control group | No intervention | Only receives measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical fitness pre - post
Via 6 minute walk test.
Measured: baseline, 10 weeks
Change in physical fitness pre - follow-up
Via 6 minute walk test.
Measured: baseline, 6 months
Change in physical activity pre - post
Via a questionnaire.
Measured: baseline, 10 weeks
Change in physical activity pre - follow-up
Via a questionnaire.
Measured: baseline, 6 months
Change in well-being pre - post
Via a questionnaire.
Measured: baseline, 10 weeks
Change in well-being pre - follow-up
Via a questionnaire.
Measured: baseline, 6 months
Secondary outcomes (2)
Change in psychosocial parameters pre - post
Via a questionnaire.
Measured: baseline, 10 weeks
Change in psychosocial parameters pre - follow-up
Via a questionnaire.
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg
- Responsible party
- Principal investigator, Prof Filip Boen, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Filip Boen, Prof., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079012
- Sponsor's protocol ID
- ML10148
- Status last verified
- Jun 2016
- First submitted
- 28 Feb 2014
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT02079012
- Acronym / sponsor ID
- ML10148
- Conditions
- Mental Disorders
- Keywords
- Walking Program, Mental Disorders, Physical Activity, Physical Fitness, Anxiety, Depression, Self Determination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Vlaamse Federatie voor Sport en Recreatie in de Geestelijke Gezondheidszorg
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: 10-week walking programReceives: * 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 |
| Control group | No intervention | –Only receives measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- Member of Psylos
- Medically approved by a physician
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10-week walking program | Behavioural | Intervention group |
Primary outcome
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.
2 secondary outcomes
Change in psychosocial parameters pre - post
Time frame: baseline, 10 weeks
Change in psychosocial parameters pre - follow-up
Time frame: baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Boen, Prof. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10-week walking program in people with Mental Disorders, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical fitness pre - post (time frame: baseline, 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.