Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

NCT ID: NCT06560749

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2026-08-31

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.

Detailed Description

The study aims to assess the impact of structured physical exercise on the cognitive function of bipolar disorder patients presenting deficits, while investigating its association to quality of life and functionality. The study will include 72 euthymic BD patients from the Bipolar Disorder Research Program (PROMAN) at the Institute of Psychiatry of the University of São Paulo Medical School, randomly distributed into two groups: 1) the experimental group will be submitted to supervised training sessions, three times per week, for 12 weeks, including aerobics and strength exercises, as well as treatment as usual (TAU); and 2) the control group will be submitted exclusively to TAU. Cognitive function, depressive and manic symptoms, quality of life and functionality will be assessed at baseline and at follow-uo (week 12), for both groups. Statistical hypothesis testing, assessing the presence of statistically significant differences between groups, pre and post intervention, should be available on the third quarter of 2025.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

The experimental group will be submitted to supervised training sessions, three times per week, for 12 weeks, of aerobics exercises, as well as treatment as usual (TAU)

Group Type: EXPERIMENTAL

Physical Exercise

Intervention Type: OTHER

Measure the impact of physical exercise in the cognition of pacients diagnosed with Bipolar Disorder

Control Group

the control group will be submitted exclusively to treatment as usual (TAU)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical Exercise

Measure the impact of physical exercise in the cognition of pacients diagnosed with Bipolar Disorder

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beny Lafer

OTHER

Sponsor Role: lead

Responsible Party

Beny Lafer

Principal INvestigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Beny Lafer, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Gabriel Okawa Belizario

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Gabriel Okawa Belizario

Role: CONTACT

gabrielokawabelizario@gmail.com

+55 (11) 963391570

Beny Lafer, M.D, Ph.D

Role: CONTACT

benylafer@gmail.com

Facility Contacts

Gabriel Belizario

Role: primary

gabrielokawabelizario@gmail.com

+55 (11)963391570

Other Identifiers

05440818.0.0000.0068

Identifier Type: -

Identifier Source: org_study_id