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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
Gabriel Okawa Belizario
RECRUITING
São Paulo
Contact Information
Primary
Gabriel Okawa Belizario
gabrielokawabelizario@gmail.com
+55 (11) 963391570
Backup
Beny Lafer, M.D, Ph.D
benylafer@gmail.com
Time Frame
Start Date: 2024-08-20
Estimated Completion Date: 2026-08
Participants
Target number of participants: 72
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Beny Lafer

This content was sourced from clinicaltrials.gov