Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

NCT06560749 | Recruiting

• 1 other identifier: 05440818.0.0000.0068
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (2)

• Functional Assessment Staging Tool (FAST)

  Baseline and Follow-up (12 weeks)

• The World Health Organization Quality of Life Assessment (WHOQOL)

  Baseline and Follow-up (12 weeks)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

the control group will be submitted exclusively to treatment as usual (TAU)

Interventions

Physical Exercise OTHER

Measure the impact of physical exercise in the cognition of pacients diagnosed with Bipolar Disorder

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Organic mental disorder
• BMI \> 40
• Alcohol or drug abuse in the last 6 months
• Use of benzodiazepines or beta-blockers in the last month

Sponsors & Collaborators

• Beny Lafer: lead

Study Sites (1)

Gabriel Okawa Belizario

São Paulo, São Paulo, 05403-903, Brazil

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Beny Lafer, M.D, Ph.D

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Okawa Belizario

CONTACT

+55 (11) 963391570; gabrielokawabelizario@gmail.com

Beny Lafer, M.D, Ph.D

CONTACT

benylafer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal INvestigator

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 19, 2024
• Study Start: August 20, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

BR (1)