Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06560749

Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

Led by Beny Lafer · Updated on 2024-08-19

72

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Bipolar Disorder I or II according to DSM-5
  • Age between 18 and 55 years old
  • Completed primary education
  • Euthymic mood state (YMRS < 8 and MADRS < 12)
  • Cognitive impairments present (COBRA > 14 and SCIP < 75)
  • Estimated IQ of 80 or higher
  • No changes in medication during the last month
  • No regular physical exercise in the past six months
  • Signed informed consent (TCLE)
Not Eligible

You will not qualify if you...

  • Presence of organic mental disorder
  • Body Mass Index (BMI) over 40
  • Alcohol or drug abuse in the last 6 months
  • Use of benzodiazepines or beta-blockers in the last month

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Gabriel Okawa Belizario

São Paulo, São Paulo, Brazil, 05403-903

Actively Recruiting

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Research Team

G

Gabriel Okawa Belizario

CONTACT

B

Beny Lafer, M.D, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder | DecenTrialz