Physical exercise program for patients with mental disorders
Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry, Efficacy Evaluation in a Randomized Controlled Multicentre Trial
This study is testing if a special exercise program called Braining can improve the mental and physical health of patients with mental disorders compared to regular exercise advice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 5 sites (Upplands Väsby, Stockholm and 4 other locations) |
| Trial ID | NCT06012149 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare a physical exercise intervention called Braining with structured advice on physical exercise for patients in psychiatric care. Participants will engage in clinician-led exercise classes up to three times a week over a twelve-week period, with assessments of their mental and physical health before and after the intervention. The study will measure the impact of Braining on physical activity levels, quality of life, and overall functional status, utilizing accelerometers and various health assessments. The trial will take place across multiple psychiatric outpatient units in Region Stockholm.
Who should consider this trial
Good fit: Ideal candidates include patients with symptoms of depression and/or anxiety who are not currently physically active according to WHO guidelines.
Not a fit: Patients who are already physically active at moderate to vigorous levels or those with severe mental disorders or medical conditions contraindicating exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance physical activity levels and improve mental health outcomes for patients with mental disorders.
How similar studies have performed: Other studies have shown promising results with physical exercise interventions in psychiatric settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient at one of the psychiatric units Exclusion Criteria: * Physically active with moderate to vigorous physical activity above recommendations from World Health Organization (WHO) during the last 4 weeks * Severe mental disorder such as ongoing mania, psychosis, and conditions when high risk of suicide or high risk of violence available according to the assessment of psychiatric staff at the unit. * Medical conditions such as heart or lung disease, infection, withdrawal, where heart rate-increasing physical activity is considered contraindicated due to Medical reasons. * Physical disability that makes it impossible to move independently to the gym and performing the indicated exercise in the training sessions. * Mental disability which means that you can not participate in group training. * Difficulty speaking or understanding the Swedish language. * Ongoing heavy substance use.
Where this trial is running
Upplands Väsby, Stockholm and 4 other locations
- Region Stockholm, Psykiatri Nordväst och Beroendecentrum, mottagningar Väsby — Upplands Väsby, Stockholm, Sweden (Not_yet_recruiting)
- Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest) — Stockholm, Sweden (Recruiting)
- Region Stockholm, Beroendecentrum, Magnus Huss — Stockholm, Sweden (Recruiting)
- Region Stockholm, Liljeholmsberget — Stockholm, Sweden (Not_yet_recruiting)
- Region Stockholm, Psykiatri Södra, Andreashuset — Stockholm, Sweden (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.