- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498730
Interval Training in Bipolar Disorder (HIIT)
July 27, 2022 updated by: Alberto Souza de Sá Filho, Universidade Federal do Rio de Janeiro
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rio de Janeiro, Brazil
- Institute of Psychiatry (IPUB)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Bipolar Criteria (DSM-IV),
- sedentary lifestyle
Exclusion Criteria:
- 60 and over,
- Cardiovascular Disease,
- Panic disorder,
- Metabolic syndrome Diagnosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interval Training
6 stimulous (30 s) at 100% VO2Max/ 1 min 30 s to rest, 19 minutes (total exercise), 3 times/ week, 12 weeks
|
High Intensity Interval Training at 100% VO2Max
Other Names:
Continuous Stimulous at 60% VO2Max
Other Names:
|
|
Active Comparator: Continuous Training
Running at 60% VO2Max, 25 minutes (total exercise), 3 times/week, 12 weeks
|
High Intensity Interval Training at 100% VO2Max
Other Names:
Continuous Stimulous at 60% VO2Max
Other Names:
|
|
Sham Comparator: Control
Only Dependent Variables Measures
|
Only Dependent Variables Measures
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom Scales (Hamilton and Young)
Time Frame: 0 week, 6 week, 12 week
|
Variable Measured to reduction of symptoms
|
0 week, 6 week, 12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortical Changes (EEG) - Loreta
Time Frame: 0 week, 6 week, 12 week
|
Measured to evaluate changes due to training
|
0 week, 6 week, 12 week
|
|
VO2Max
Time Frame: 0 week, 6 week, 12 week
|
Variable Measured to assess cardiovascular improvement
|
0 week, 6 week, 12 week
|
|
Cognitive Function
Time Frame: 0 week, 6 week, 12 week
|
Executive Function, Time Reaction, Atention, and Memory
|
0 week, 6 week, 12 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Sérgio E. Machado, PhD, Universidade Federal do Rio de Janeiro
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
July 11, 2015
First Submitted That Met QC Criteria
July 14, 2015
First Posted (Estimate)
July 15, 2015
Study Record Updates
Last Update Posted (Actual)
July 29, 2022
Last Update Submitted That Met QC Criteria
July 27, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFRJ-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bipolar Disorder
-
Vielight Inc.Not yet recruitingBipolar Disorder (BD) | Bipolar | Bipolar Disorder DepressionCanada
-
ProgenaBiomeWithdrawnBipolar Disorder | Bipolar I Disorder | Bipolar II Disorder | Bipolar Type I Disorder | Bipolar Disorder Mild | Bipolar Disorder Moderate | Bipolar Disorder SevereUnited States
-
Xenon Pharmaceuticals Inc.RecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderUnited States
-
Xenon Pharmaceuticals Inc.Enrolling by invitationBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderUnited States
-
Rush University Medical CenterThe Ryan Licht Sang Bipolar FoundationCompletedBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar Disorder I | Bipolar Affective DisorderUnited States
-
University of California, Los AngelesUniversity of Colorado, Denver; University of Pittsburgh; University of Cincinnati and other collaboratorsRecruitingAdolescents | Bipolar Disorder (BD) | Bipolar Disorder I or II | Bipolar Disorder NOS | Bipolar Spectrum DisorderUnited States
-
Babes-Bolyai UniversityRecruitingBipolar Disorder (BD)Romania
-
Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do Sul; Hospital Moinhos de VentoActive, not recruitingBipolar Disorder | Bipolar Depression | Major Depressive Disorder | Bipolar I Disorder | Affective Disorder | Bipolar II DisorderBrazil
-
University of PittsburghNational Alliance for Research on Schizophrenia and DepressionCompletedBipolar I Disorder | Bipolar II Disorder | Bipolar Disorder NOSUnited States
-
Korea University Anam HospitalHucircadian; Korea University MedicineEnrolling by invitationMood Disorders | Bipolar Disorder (BD) | Depression - Major Depressive Disorder | Depression BipolarSouth Korea
Clinical Trials on Interval Training
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
University Hospital, MontpellierRecruiting
-
Norwegian University of Science and TechnologyAarhus University HospitalCompleted
-
St. Olavs HospitalNorwegian University of Science and TechnologyCompletedTachycardia, Ventricular | Defibrillators, ImplantableNorway
-
Riphah International UniversityCompletedMyocardial InfarctionPakistan
-
Kuopio Research Institute of Exercise MedicineKuopio University Hospital; University of Basel; University of Eastern Finland; Social Insurance Institution, FinlandTerminatedUnstable Angina Pectoris | Acute Myocardial Infarction | Recurrent Myocardial InfarctionFinland
-
Cairo UniversityKasr El Aini HospitalCompletedDiabetes Mellitus, Type 2Egypt
-
Universidad Santo TomasCompletedMetabolic DiseasesColombia
-
Norwegian University of Science and TechnologyCompletedObesity | OverweightNorway
-
Universidad SurcolombianaMaciste Macias; Gilberto AstaizaRecruiting