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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Control Group | No Intervention | the control group will be submitted exclusively to treatment as usual (TAU) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Exercise | Other | Measure the impact of physical exercise in the cognition of pacients diagnosed with Bipolar Disorder |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriel Okawa Belizario | Contact | +55 (11) 963391570 | gabrielokawabelizario@gmail.com | |
| Beny Lafer, M.D, Ph.D | Contact | benylafer@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Beny Lafer, M.D, Ph.D | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabriel Okawa Belizario | Recruiting | São Paulo | São Paulo | 05403-903 | Brazil |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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) |
Scale used to assess patients quality of life.
| Baseline and Follow-up (12 weeks) |