Physical exercise to improve cognitive function in bipolar disorder patients
Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder: a Controlled and Randomized Study
This study is testing if a structured exercise program can help improve thinking skills and quality of life for people with bipolar disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06560749 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of structured physical exercise as an additional treatment for cognitive impairments in patients diagnosed with Bipolar Disorder. It involves 72 euthymic patients who will be randomly assigned to either a group receiving supervised exercise sessions three times a week for 12 weeks or a control group receiving standard treatment only. The study aims to assess changes in cognitive functions, quality of life, and functionality, as well as correlations with physiological variables. Assessments will be conducted at baseline and after the intervention period to determine the effectiveness of the exercise program.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-55 with a diagnosis of Bipolar Disorder who are currently euthymic and exhibit cognitive impairments.
Not a fit: Patients with organic mental disorders, severe obesity, or recent substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cognitive function and overall quality of life for patients with bipolar disorder.
How similar studies have performed: Previous studies have shown promising results in using physical exercise to improve cognitive function in various mental health conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Bipolar disorder (BD) I and II according to DSM-5 * Age: 18 - 55 years old * Complete primary education * Euthymic (YMRS \< 8 and MADRS \< 12) * Presence of cognitive impairments (COBRA \> 14 and SCIP \< 75) * Estimated IQ ≥ 80 * No medication changes in the last month * Having been without regular PE practice for six months * Signature of the TCLE Exclusion Criteria: * Organic mental disorder * BMI \> 40 * Alcohol or drug abuse in the last 6 months * Use of benzodiazepines or beta-blockers in the last month
Where this trial is running
São Paulo, São Paulo
- Gabriel Okawa Belizario — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Beny Lafer, M.D, Ph.D — University of Sao Paulo
- Study coordinator: Gabriel Okawa Belizario
- Email: gabrielokawabelizario@gmail.com
- Phone: +55 (11) 963391570
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.