Bipolar DisorderHIITNCT02498730
Interval Training in Bipolar Disorder
A study testing Interval Training and Continuous Training in people with Bipolar Disorder, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
Our main objective will be to evaluate the chronic effects (12 weeks) of high-intensity interval training compared to moderate intensity (same total work) on reducing the symptoms of bipolar disorder, cortical changes, as well as on the VO2max. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Interval Training and Continuous Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Bipolar Criteria (DSM-IV),
- sedentary lifestyle
Who cannot join
- 60 and over,
- Cardiovascular Disease,
- Panic disorder,
- Metabolic syndrome Diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the High Intensity Interval Training (HIIT) Deliver Superior and Rapid Decrease of Symptoms of Bipolar Disorder? a Controlled and Randomized Study
Our main objective will be to evaluate the chronic effects (12 weeks) of high-intensity interval training compared to moderate intensity (same total work) on reducing the symptoms of bipolar disorder, cortical changes, as well as on the VO2max. In addition, the investigators will establish what influence of gain to VO2max has on reducing symptoms.
Read the detailed description
Physical exercise has significant effects on health promotion and the consequent reduction of the severity of bipolar disorder (BD). This review establishes a pattern of response of exercise and potential impact on the pathophysiology of BD; , as well as, produces hypotheses on how acute and chronic effect of exercises may act differently; and provides future perspectives with the focus of the exercise as an important and innovative model of treatment for BD and mental disorder. A critical evaluation of the literature was undertaken including the influence of exercise on health promotion in patients with mental disorders, neurochemical behavior exercise-induced, as well as reflective introduction of news perspectives of training control in severe exercise domain. The exercise induces significant changes in monoaminergic after, and with long-term training, and work with a threshold of exercise can modulate positive effects on mood. Fast adaptive effects from the high intensity interval training should be considered in BD patients. However, there must be caution in his administration. We speculate that exercise may be a way of maintaining euthymia in the case of BD, making it less vulnerable patient to stay longer at a time of neutrality. Future research is needed to adopt a training strategy that is both time efficient in the different areas and adequate for the population in question.
- Conditions
- Bipolar Disorder
- Being tested
- Interval Training, Continuous Training, Control
- Keywords
- bipolar disorder, VO2max, aerobic exercise
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval TrainingBehavioural
Also called High intensity interval training, HIIT, HIT
High Intensity Interval Training at 100% VO2Max
Continuous TrainingBehavioural
Also called Moderate Training, Endurance
Continuous Stimulous at 60% VO2Max
ControlBehavioural
Also called No Intervention
Only Dependent Variables Measures
| Study group | Role | What they receive |
|---|---|---|
| Interval Training | Active comparator | 6 stimulous (30 s) at 100% VO2Max/ 1 min 30 s to rest, 19 minutes (total exercise), 3 times/ week, 12 weeks Receives: Behavioral: Interval Training; Behavioral: Continuous Training |
| Continuous Training | Active comparator | Running at 60% VO2Max, 25 minutes (total exercise), 3 times/week, 12 weeks Receives: Behavioral: Interval Training; Behavioral: Continuous Training |
| Control | Sham comparator | Only Dependent Variables Measures Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Scales (Hamilton and Young)
Variable Measured to reduction of symptoms
Measured: 0 week, 6 week, 12 week
Secondary outcomes (3)
Cortical Changes (EEG) - Loreta
Measured to evaluate changes due to training
Measured: 0 week, 6 week, 12 week
VO2Max
Variable Measured to assess cardiovascular improvement
Measured: 0 week, 6 week, 12 week
Cognitive Function
Executive Function, Time Reaction, Atention, and Memory
Measured: 0 week, 6 week, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2017
- Study completionJul 2017
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Souza de Sá Filho, Universidade Federal do Rio de Janeiro
- Investigators
- Sérgio E. Machado, PhD, Study director, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498730
- Sponsor's protocol ID
- UFRJ-01
- Acronym
- HIIT
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2015
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the High Intensity Interval Training (HIIT) Deliver Superior and Rapid Decrease of Symptoms of Bipolar Disorder? a Controlled and Randomized Study
- ClinicalTrials.gov ID
- NCT02498730
- Acronym / sponsor ID
- HIIT / UFRJ-01
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, VO2max, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 15 Jul 2015 (estimated)
- 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.
Our main objective will be to evaluate the chronic effects (12 weeks) of high-intensity interval training compared to moderate intensity (same total work) on reducing the symptoms of bipolar disorder, cortical changes, as well as on the VO2max. In addition, the investigators will establish what influence of gain to VO2max has on reducing symptoms.
Detailed description
Physical exercise has significant effects on health promotion and the consequent reduction of the severity of bipolar disorder (BD). This review establishes a pattern of response of exercise and potential impact on the pathophysiology of BD; , as well as, produces hypotheses on how acute and chronic effect of exercises may act differently; and provides future perspectives with the focus of the exercise as an important and innovative model of treatment for BD and mental disorder. A critical evaluation of the literature was undertaken including the influence of exercise on health promotion in patients with mental disorders, neurochemical behavior exercise-induced, as well as reflective introduction of news perspectives of training control in severe exercise domain. The exercise induces significant changes in monoaminergic after, and with long-term training, and work with a threshold of exercise can modulate positive effects on mood. Fast adaptive effects from the high intensity interval training should be considered in BD patients. However, there must be caution in his administration. We speculate that exercise may be a way of maintaining euthymia in the case of BD, making it less vulnerable patient to stay longer at a time of neutrality. Future research is needed to adopt a training strategy that is both time efficient in the different areas and adequate for the population in question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Interval Training | Active comparator | Behavioral: Interval Training, Behavioral: Continuous Training6 stimulous (30 s) at 100% VO2Max/ 1 min 30 s to rest, 19 minutes (total exercise), 3 times/ week, 12 weeks |
| Continuous Training | Active comparator | Behavioral: Interval Training, Behavioral: Continuous TrainingRunning at 60% VO2Max, 25 minutes (total exercise), 3 times/week, 12 weeks |
| Control | Sham comparator | Behavioral: ControlOnly Dependent Variables Measures |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Bipolar Criteria (DSM-IV),
- sedentary lifestyle
Key exclusion criteria (4 listed)
- 60 and over,
- Cardiovascular Disease,
- Panic disorder,
- Metabolic syndrome Diagnosis
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 |
|---|---|---|
| Interval TrainingAlso: High intensity interval training, HIIT, HITHigh Intensity Interval Training at 100% VO2Max | Behavioural | Continuous Training, Interval Training |
| Continuous TrainingAlso: Moderate Training, EnduranceContinuous Stimulous at 60% VO2Max | Behavioural | Continuous Training, Interval Training |
| ControlAlso: No InterventionOnly Dependent Variables Measures | Behavioural | Control |
Primary outcome
Symptom Scales (Hamilton and Young)
Time frame: 0 week, 6 week, 12 week
Variable Measured to reduction of symptoms
3 secondary outcomes
Cortical Changes (EEG) - Loreta
Time frame: 0 week, 6 week, 12 week
VO2Max
Time frame: 0 week, 6 week, 12 week
Cognitive Function
Time frame: 0 week, 6 week, 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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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. This study is not recruiting at the moment.
Sérgio E. Machado, PhD study director
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval Training and Continuous Training in people with Bipolar Disorder, run by Universidade Federal do Rio de Janeiro 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 2 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: finished, as of the sponsor's last update on 29 Jul 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Scales (Hamilton and Young) (time frame: 0 week, 6 week, 12 week). 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 29 Jul 2022.