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NCT Number: NCT06560749

Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

Other

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

Primary outcomes

  1. Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: Baseline, Week 4, Week 8 and Follow-up (12 weeks)

    Scale used to assess the presence and intensity of depressive symptoms.

  2. Young Mania Rating Scale (YMRS)

    Time frame: Baseline, Week 4, Week 8 and Follow-up (12 weeks)

    Scale used to assess the presence and intensity of manic symptoms.

  3. Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA)

    Time frame: Baseline only

    Screening scale for the presence of cognitive deficits. Suggested cutoff point is 14

  4. Screen for Cognitive Impairment in Psychiatry (SCIP)

    Time frame: Baseline only

    Subjective screening scale for difficulties associated with cognitive impairment. Suggested cutoff point is 70

  5. Stroop Color-Word Test (Spreen and Strauss, 1998)

    Time frame: Baseline and Follow-up (12 weeks)

    Assessing mental flexibility and inhibitory control (attention and executive function)

  6. Verbal Fluency - F.A.S (Spreen and Strauss, 1998)

    Time frame: Baseline and Follow-up (12 weeks)

    Assessing verbal fluency, inhibitory control and the correct use of strategies (executive function)

  7. Trail Making Test (Spreen and Strauss, 1998)

    Time frame: Baseline and Follow-up (12 weeks)

    Assessing alternating attention

  8. Logical Memory I and II (Wechsler, 1997b)

    Time frame: Baseline and Follow-up (12 weeks)

    Assessing verbal memory

  9. List of Words (Wechsler, 1997a)

    Time frame: Baseline and Follow-up (12 weeks)

    Assessing learning capacity and attention

  10. Cardiovascular evaluation

    Time frame: Baseline and Follow-up (12 weeks)

    All patients will undergo an electrocardiogram computerized.

  11. Stress test on the treadmill

    Time frame: Baseline and Follow-up (12 weeks)

    A treadmill stress test will be performed.

  12. Respiratory gas exchange analysis (ergospirometric)

    Time frame: Baseline and Follow-up (12 weeks)

    A computerized gas exchange analysis system will be used (CPX/ULTIMA, Medgraphics®, Saint Paul, MN, USA)

  13. Isokinetic Strength Test

    Time frame: Baseline and Follow-up (12 weeks)

    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).

  14. Body composition by bioimpedance

    Time frame: Baseline and Follow-up (12 weeks)

    Body composition measurements will be obtained by the non-invasive indirect bioimpedance method using a scale

  15. Anthropometric measurements (skinfolds) and calculation of body composition

    Time frame: Baseline and Follow-up (12 weeks)

    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.

  16. One Repetition Maximum Test (1RM)

    Time frame: Baseline and Follow-up (12 weeks)

    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).

  17. Wechsler Abbreviated Scale of Intelligence (WASI)

    Time frame: Baseline and Follow-up (12 weeks)

    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.

  18. Digit Span Memory Test

    Time frame: Baseline and Follow-up (12 weeks)

    short test that evaluates a person's memory and cognitive status

  19. Cognitive Emotion Regulation Questionnaire (CERQ)

    Time frame: Baseline and Follow-up (12 weeks)

    Questionnaire measuring cognitive coping strategies

  20. Difficulties in Emotion Regulation Scale (DERS)

    Time frame: Baseline and Follow-up (12 weeks)

    Instrument measuring emotion regulation problems

Secondary outcomes

  1. Functional Assessment Staging Tool (FAST)

    Time frame: Baseline and Follow-up (12 weeks)

    Scale used to assess the patient's global functionality.

  2. The World Health Organization Quality of Life Assessment (WHOQOL)

    Time frame: Baseline and Follow-up (12 weeks)

    Scale used to assess patients quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Beny Lafer, M.D, Ph.D

CONTACT

[email protected]

Gabriel Okawa Belizario

CONTACT

[email protected]

+55 (11) 963391570

Sponsors and collaborators

Lead sponsor

Beny Lafer

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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