Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder
NCT Number: NCT06560749
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bipolar Disorder
Interventions: OTHER: Physical Exercise
Sponsor: Beny Lafer
Sex: ALL
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING
Start Date: 2024-08-20
Completion Date: 2026-08
Locations: Gabriel Okawa Belizario, São Paulo, Sp, 05403-903, Brazil

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.

Primary Outcome Measures: 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: 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)