NCT02498730

Brief 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. In addition, the investigators will establish what influence of gain to VO2max has on reducing symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

1.9 years

First QC Date

July 11, 2015

Last Update Submit

July 27, 2022

Conditions

Keywords

bipolar disorderVO2maxaerobic exercise

Outcome Measures

Primary Outcomes (1)

  • Symptom Scales (Hamilton and Young)

    Variable Measured to reduction of symptoms

    0 week, 6 week, 12 week

Secondary Outcomes (3)

  • Cortical Changes (EEG) - Loreta

    0 week, 6 week, 12 week

  • VO2Max

    0 week, 6 week, 12 week

  • Cognitive Function

    0 week, 6 week, 12 week

Study Arms (3)

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

Behavioral: Interval TrainingBehavioral: Continuous Training

Continuous Training

ACTIVE COMPARATOR

Running at 60% VO2Max, 25 minutes (total exercise), 3 times/week, 12 weeks

Behavioral: Interval TrainingBehavioral: Continuous Training

Control

SHAM COMPARATOR

Only Dependent Variables Measures

Behavioral: Control

Interventions

High Intensity Interval Training at 100% VO2Max

Also known as: High intensity interval training, HIIT, HIT
Continuous TrainingInterval Training

Continuous Stimulous at 60% VO2Max

Also known as: Moderate Training, Endurance
Continuous TrainingInterval Training
ControlBEHAVIORAL

Only Dependent Variables Measures

Also known as: No Intervention
Control

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Bipolar Criteria (DSM-IV),
  • sedentary lifestyle

You may not qualify if:

  • and over,
  • Cardiovascular Disease,
  • Panic disorder,
  • Metabolic syndrome Diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatry (IPUB)

Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sérgio E. Machado, PhD

    Universidade Federal do Rio de Janeiro

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctorade in Mental Health

Study Record Dates

First Submitted

July 11, 2015

First Posted

July 15, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 29, 2022

Record last verified: 2022-07

Locations