NCT06560749 Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder
| NCT ID | NCT06560749 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beny Lafer |
| Condition | Bipolar Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2024-08-20 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2024-08-20 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the impact of Physical Exercise (PE), as an adjuvant treatment, on the cognition of patients diagnosed with Bipolar Disorder who present cognitive impairments, as well as its impact on quality of life and functionality and its association with physiological variables. Our specific goals are: 1. Evaluate the effect of PE on the neuropsychological functions of attention, memory, verbal fluency, executive function and processing speed in patients diagnosed with BD who present cognitive impairments in these domains. 2. To evaluate the effect of PE on the quality of life and functionality of patients diagnosed with BD, as well as possible associations with cognitive functions. 3. To evaluate possible correlations between physiological variables, such as cardiorespiratory indices, strength and body composition, and improvements in cognitive functions, quality of life and functionality.
Eligibility 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
Contact & Investigator
Beny Lafer, M.D, Ph.D
PRINCIPAL INVESTIGATOR
University of Sao Paulo
Frequently Asked Questions
Who can join the NCT06560749 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Bipolar Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06560749 currently recruiting?
Yes, NCT06560749 is actively recruiting participants. Contact the research team at gabrielokawabelizario@gmail.com for enrollment information.
Where is the NCT06560749 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06560749 clinical trial?
NCT06560749 is sponsored by Beny Lafer. The principal investigator is Beny Lafer, M.D, Ph.D at University of Sao Paulo. The trial plans to enroll 72 participants.
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