Clinical trial NCT06560749: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, Week 4, Week 8 and Follow-up (12 weeks)
measure: Young Mania Rating Scale (YMRS)
timeFrame: Baseline, Week 4, Week 8 and Follow-up (12 weeks)
measure: Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA)
timeFrame: Baseline only
measure: Screen for Cognitive Impairment in Psychiatry (SCIP)
timeFrame: Baseline only
measure: Stroop Color-Word Test (Spreen and Strauss, 1998)
timeFrame: Baseline and Follow-up (12 weeks)
measure: Verbal Fluency - F.A.S (Spreen and Strauss, 1998)
timeFrame: Baseline and Follow-up (12 weeks)
measure: Trail Making Test (Spreen and Strauss, 1998)
timeFrame: Baseline and Follow-up (12 weeks)
measure: Logical Memory I and II (Wechsler, 1997b)
timeFrame: Baseline and Follow-up (12 weeks)
measure: List of Words (Wechsler, 1997a)
timeFrame: Baseline and Follow-up (12 weeks)
measure: Cardiovascular evaluation
timeFrame: Baseline and Follow-up (12 weeks)
measure: Stress test on the treadmill
timeFrame: Baseline and Follow-up (12 weeks)
measure: Respiratory gas exchange analysis (ergospirometric)
timeFrame: Baseline and Follow-up (12 weeks)
measure: Isokinetic Strength Test
timeFrame: Baseline and Follow-up (12 weeks)
measure: Body composition by bioimpedance
timeFrame: Baseline and Follow-up (12 weeks)
measure: Anthropometric measurements (skinfolds) and calculation of body composition
timeFrame: Baseline and Follow-up (12 weeks)
measure: One Repetition Maximum Test (1RM)
timeFrame: Baseline and Follow-up (12 weeks)
measure: Wechsler Abbreviated Scale of Intelligence (WASI)
timeFrame: Baseline and Follow-up (12 weeks)
measure: Digit Span Memory Test
timeFrame: Baseline and Follow-up (12 weeks)
measure: Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: Baseline and Follow-up (12 weeks)
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline and Follow-up (12 weeks)
Secondary outcomes:
measure: Functional Assessment Staging Tool (FAST)
timeFrame: Baseline and Follow-up (12 weeks)
measure: The World Health Organization Quality of Life Assessment (WHOQOL)
timeFrame: Baseline and Follow-up (12 weeks)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Gabriel Okawa Belizario
state: Sp
Study officials:
affiliation: University of Sao Paulo
name: Beny Lafer, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: