Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

Sponsor
Beny Lafer
Study ID
NCT06560749
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 19, 2024
Start date
Aug 20, 2024
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: 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)
  • No Intervention: Control Group
    the control group will be submitted exclusively to treatment as usual (TAU)

Primary Outcome Measure

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, Week 4, Week 8 and Follow-up (12 weeks) ]

Central Contacts

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