Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder
• Intervention / Treatment: Other: Physical Exercise

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriel Okawa Belizario; Phone Number: +55 (11) 963391570; Email: gabrielokawabelizario@gmail.com
• Study Contact Backup: Name: Beny Lafer, M.D, Ph.D; Email: benylafer@gmail.com

Study Locations

• Brazil
  • Sp
    • São Paulo, Sp, Brazil, 05403-903
      • Recruiting
      • Gabriel Okawa Belizario
      • Contact: Gabriel Belizario; Phone Number: +55 (11)963391570; Email: gabrielokawabelizario@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Other: Physical Exercise; Measure the impact of physical exercise in the cognition of pacients diagnosed with Bipolar Disorder
No Intervention: Control Group; the control group will be submitted exclusively to treatment as usual (TAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)	Scale used to assess the presence and intensity of depressive symptoms.	Baseline, Week 4, Week 8 and Follow-up (12 weeks)
Young Mania Rating Scale (YMRS)	Scale used to assess the presence and intensity of manic symptoms.	Baseline, Week 4, Week 8 and Follow-up (12 weeks)
Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA)	Screening scale for the presence of cognitive deficits. Suggested cutoff point is 14	Baseline only
Screen for Cognitive Impairment in Psychiatry (SCIP)	Subjective screening scale for difficulties associated with cognitive impairment. Suggested cutoff point is 70	Baseline only
Stroop Color-Word Test (Spreen and Strauss, 1998)	Assessing mental flexibility and inhibitory control (attention and executive function)	Baseline and Follow-up (12 weeks)
Verbal Fluency - F.A.S (Spreen and Strauss, 1998)	Assessing verbal fluency, inhibitory control and the correct use of strategies (executive function)	Baseline and Follow-up (12 weeks)
Trail Making Test (Spreen and Strauss, 1998)	Assessing alternating attention	Baseline and Follow-up (12 weeks)
Logical Memory I and II (Wechsler, 1997b)	Assessing verbal memory	Baseline and Follow-up (12 weeks)
List of Words (Wechsler, 1997a)	Assessing learning capacity and attention	Baseline and Follow-up (12 weeks)
Cardiovascular evaluation	All patients will undergo an electrocardiogram computerized.	Baseline and Follow-up (12 weeks)
Stress test on the treadmill	A treadmill stress test will be performed.	Baseline and Follow-up (12 weeks)
Respiratory gas exchange analysis (ergospirometric)	A computerized gas exchange analysis system will be used (CPX/ULTIMA, Medgraphics®, Saint Paul, MN, USA)	Baseline and Follow-up (12 weeks)
Isokinetic Strength Test	The isokinetic test will be performed on the lower limbs (extensor and flexor muscles of the knee joints) on the dominant (R) and non-dominant (ND) leg at an angular velocity of 60 s -1 using a computerized isokinetic dynamometer (Biodex®, Inc . USA).	Baseline and Follow-up (12 weeks)
Body composition by bioimpedance	Body composition measurements will be obtained by the non-invasive indirect bioimpedance method using a scale	Baseline and Follow-up (12 weeks)
Anthropometric measurements (skinfolds) and calculation of body composition	Body mass (BM) will be measured on a Filizola mechanical scale, with an accuracy of 0.1 kg. Height will be determined using a stadiometer, attached to the scale, with an accuracy of 0.1cm (Gordon et al., 1988). Body composition will be determined using the skinfold thickness technique.	Baseline and Follow-up (12 weeks)
One Repetition Maximum Test (1RM)	The exercises to be tested are the seated bench press (pectoral muscles), leg-press (quadriceps and glutes), rowing (dorsal muscles), standing knee bending chair (hamstrings), abdominal (rectus and abdominal obliques).	Baseline and Follow-up (12 weeks)
Wechsler Abbreviated Scale of Intelligence (WASI)	delivers an estimation of a student's general intellectual ability by measuring the verbal, nonverbal, and general cognition of individuals from 6 to 89 years of age.	Baseline and Follow-up (12 weeks)
Digit Span Memory Test	short test that evaluates a person's memory and cognitive status	Baseline and Follow-up (12 weeks)
Cognitive Emotion Regulation Questionnaire (CERQ)	Questionnaire measuring cognitive coping strategies	Baseline and Follow-up (12 weeks)
Difficulties in Emotion Regulation Scale (DERS)	Instrument measuring emotion regulation problems	Baseline and Follow-up (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment Staging Tool (FAST)	Scale used to assess the patient's global functionality.	Baseline and Follow-up (12 weeks)
The World Health Organization Quality of Life Assessment (WHOQOL)	Scale used to assess patients quality of life.	Baseline and Follow-up (12 weeks)

Collaborators and Investigators

• Sponsor: Beny Lafer
• Investigators: Principal Investigator: Beny Lafer, M.D, Ph.D, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Bipolar Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder; Mood Disorders
• Other Study ID Numbers: 05440818.0.0000.0068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No