Effects of a Walking Program in People With Mental Disorders
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgien, 3000
- KU Leuven
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- At least 18 years old
- Member of Psylos
- Medically approved by a physician
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention group
Receives:
|
|
|
Inget ingripande: Control group
Only receives measurements.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in physical fitness pre - post
Tidsram: baseline, 10 weeks
|
Via 6 minute walk test.
|
baseline, 10 weeks
|
|
Change in physical fitness pre - follow-up
Tidsram: baseline, 6 months
|
Via 6 minute walk test.
|
baseline, 6 months
|
|
Change in physical activity pre - post
Tidsram: baseline, 10 weeks
|
Via a questionnaire.
|
baseline, 10 weeks
|
|
Change in physical activity pre - follow-up
Tidsram: baseline, 6 months
|
Via a questionnaire.
|
baseline, 6 months
|
|
Change in well-being pre - post
Tidsram: baseline, 10 weeks
|
Via a questionnaire.
|
baseline, 10 weeks
|
|
Change in well-being pre - follow-up
Tidsram: baseline, 6 months
|
Via a questionnaire.
|
baseline, 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in psychosocial parameters pre - post
Tidsram: baseline, 10 weeks
|
Via a questionnaire.
|
baseline, 10 weeks
|
|
Change in psychosocial parameters pre - follow-up
Tidsram: baseline, 6 months
|
Via a questionnaire.
|
baseline, 6 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Filip Boen, Prof., KU Leuven
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ML10148
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .