Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

Beny Lafer72 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Montgomery-Asberg Depression Rating Scale (MADRS)

Scale used to assess the presence and intensity of depressive symptoms.

Time frame: Baseline, Week 4, Week 8 and Follow-up (12 weeks)

Young Mania Rating Scale (YMRS)

Scale used to assess the presence and intensity of manic symptoms.

Time frame: Baseline, Week 4, Week 8 and Follow-up (12 weeks)

Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA)

Screening scale for the presence of cognitive deficits. Suggested cutoff point is 14

Time frame: Baseline only

Screen for Cognitive Impairment in Psychiatry (SCIP)

Subjective screening scale for difficulties associated with cognitive impairment. Suggested cutoff point is 70

Time frame: Baseline only

Stroop Color-Word Test (Spreen and Strauss, 1998)

Assessing mental flexibility and inhibitory control (attention and executive function)