Bipolar DisorderNCT06560749
Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder
A study testing Physical Exercise in people with Bipolar Disorder, run by Beny Lafer at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Physical Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- No medication changes in the last month
- Having been without regular PE practice for six months
- Signature of the TCLE
Who cannot join
- Organic mental disorder
- BMI > 40
- Alcohol or drug abuse in the last 6 months
- Use of benzodiazepines or beta-blockers in the last month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Beny Lafer, M.D, Ph.D contact
Brazil1 site, 1 recruiting
- Recruiting
Gabriel Okawa Belizario
São Paulo, São Paulo, 05403-903
Gabriel Belizario, +55 (11)963391570, gabrielokawabelizario@gmail.com
About this study
Official title: 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:
- 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.
- 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.
- 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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Physical Exercise
- Keywords
- Bipolar Disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseOther
Measure the impact of physical exercise in the cognition of pacients diagnosed with Bipolar Disorder
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Physical Exercise |
| Control Group | No intervention | the control group will be submitted exclusively to treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
Scale used to assess the presence and intensity of depressive symptoms.
Measured: 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.
Measured: 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
Measured: Baseline only
Screen for Cognitive Impairment in Psychiatry (SCIP)
Subjective screening scale for difficulties associated with cognitive impairment. Suggested cutoff point is 70
Measured: Baseline only
Stroop Color-Word Test (Spreen and Strauss, 1998)
Assessing mental flexibility and inhibitory control (attention and executive function)
Measured: 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)
Measured: Baseline and Follow-up (12 weeks)
Trail Making Test (Spreen and Strauss, 1998)
Assessing alternating attention
Measured: Baseline and Follow-up (12 weeks)
Logical Memory I and II (Wechsler, 1997b)
Assessing verbal memory
Measured: Baseline and Follow-up (12 weeks)
List of Words (Wechsler, 1997a)
Assessing learning capacity and attention
Measured: Baseline and Follow-up (12 weeks)
Cardiovascular evaluation
All patients will undergo an electrocardiogram computerized.
Measured: Baseline and Follow-up (12 weeks)
Stress test on the treadmill
A treadmill stress test will be performed.
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline and Follow-up (12 weeks)
Digit Span Memory Test
short test that evaluates a person's memory and cognitive status
Measured: Baseline and Follow-up (12 weeks)
Cognitive Emotion Regulation Questionnaire (CERQ)
Questionnaire measuring cognitive coping strategies
Measured: Baseline and Follow-up (12 weeks)
Difficulties in Emotion Regulation Scale (DERS)
Instrument measuring emotion regulation problems
Measured: Baseline and Follow-up (12 weeks)
Secondary outcomes (2)
Functional Assessment Staging Tool (FAST)
Scale used to assess the patient's global functionality.
Measured: Baseline and Follow-up (12 weeks)
The World Health Organization Quality of Life Assessment (WHOQOL)
Scale used to assess patients quality of life.
Measured: Baseline and Follow-up (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start20 Aug 2024
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beny Lafer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beny Lafer, University of Sao Paulo
- Investigators
- Beny Lafer, M.D, Ph.D, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560749
- Sponsor's protocol ID
- 05440818.0.0000.0068
- Status last verified
- Jul 2026
- First submitted
- 13 Aug 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder: a Controlled and Randomized Study
- ClinicalTrials.gov ID
- NCT06560749
- Acronym / sponsor ID
- 05440818.0.0000.0068
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Beny LaferUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Physical ExerciseThe 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- Organic mental disorder
- BMI > 40
- Alcohol or drug abuse in the last 6 months
- Use of benzodiazepines or beta-blockers in the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ExerciseMeasure the impact of physical exercise in the cognition of pacients diagnosed with Bipolar Disorder | Other | Intervention Group |
Primary outcome
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.
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.
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
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
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)
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)
Trail Making Test (Spreen and Strauss, 1998)
Time frame: Baseline and Follow-up (12 weeks)
Assessing alternating attention
Logical Memory I and II (Wechsler, 1997b)
Time frame: Baseline and Follow-up (12 weeks)
Assessing verbal memory
List of Words (Wechsler, 1997a)
Time frame: Baseline and Follow-up (12 weeks)
Assessing learning capacity and attention
Cardiovascular evaluation
Time frame: Baseline and Follow-up (12 weeks)
All patients will undergo an electrocardiogram computerized.
Stress test on the treadmill
Time frame: Baseline and Follow-up (12 weeks)
A treadmill stress test will be performed.
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)
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).
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
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.
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).
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.
Digit Span Memory Test
Time frame: Baseline and Follow-up (12 weeks)
short test that evaluates a person's memory and cognitive status
Cognitive Emotion Regulation Questionnaire (CERQ)
Time frame: Baseline and Follow-up (12 weeks)
Questionnaire measuring cognitive coping strategies
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline and Follow-up (12 weeks)
Instrument measuring emotion regulation problems
2 secondary outcomes
Functional Assessment Staging Tool (FAST)
Time frame: Baseline and Follow-up (12 weeks)
The World Health Organization Quality of Life Assessment (WHOQOL)
Time frame: Baseline and Follow-up (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beny Lafer, M.D, Ph.D contact
Beny Lafer, M.D, Ph.D principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise in people with Bipolar Disorder, run by Beny Lafer at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Okawa Belizario (+55 (11) 963391570, gabrielokawabelizario@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Baseline, Week 4, Week 8 and Follow-up (12 weeks)). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.