Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560749
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder a Controlled and Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None