Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

Official title

Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder: a Controlled and Randomized Study

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.

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.

Interventions

• Other Physical Exercise
  Measure the impact of physical exercise in the cognition of pacients diagnosed with Bipolar Disorder

Primary outcome measures

• Montgomery-Asberg Depression Rating Scale (MADRS) [Time frame: Baseline, Week 4, Week 8 and Follow-up (12 weeks)]
• Young Mania Rating Scale (YMRS) [Time frame: Baseline, Week 4, Week 8 and Follow-up (12 weeks)]
• Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) [Time frame: Baseline only]
• Screen for Cognitive Impairment in Psychiatry (SCIP) [Time frame: Baseline only]
• Stroop Color-Word Test (Spreen and Strauss, 1998) [Time frame: Baseline and Follow-up (12 weeks)]
• Verbal Fluency - F.A.S (Spreen and Strauss, 1998) [Time frame: Baseline and Follow-up (12 weeks)]
• Trail Making Test (Spreen and Strauss, 1998) [Time frame: Baseline and Follow-up (12 weeks)]
• Logical Memory I and II (Wechsler, 1997b) [Time frame: Baseline and Follow-up (12 weeks)]
• List of Words (Wechsler, 1997a) [Time frame: Baseline and Follow-up (12 weeks)]
• Cardiovascular evaluation [Time frame: Baseline and Follow-up (12 weeks)]

Secondary outcome measures (2)

• Functional Assessment Staging Tool (FAST) [Time frame: Baseline and Follow-up (12 weeks)]
• The World Health Organization Quality of Life Assessment (WHOQOL) [Time frame: Baseline and Follow-up (12 weeks)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Screening

Study locations

Brazil · 1 center

• Gabriel Okawa Belizario — São Paulo

Identifiers

NCT: NCT06560749 · 05440818.0.0000.0068

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗