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Interval Training in Bipolar Disorder (HIIT)

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Interval Training
Continuous Training
Control
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar disorder, VO2max, aerobic exercise

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Institute of Psychiatry (IPUB)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Interval Training

Continuous Training

Control

Arm Description

6 stimulous (30 s) at 100% VO2Max/ 1 min 30 s to rest, 19 minutes (total exercise), 3 times/ week, 12 weeks

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

Only Dependent Variables Measures

Outcomes

Primary Outcome Measures

Symptom Scales (Hamilton and Young)
Variable Measured to reduction of symptoms

Secondary Outcome Measures

Cortical Changes (EEG) - Loreta
Measured to evaluate changes due to training
VO2Max
Variable Measured to assess cardiovascular improvement
Cognitive Function
Executive Function, Time Reaction, Atention, and Memory

Full Information

First Posted
July 11, 2015
Last Updated
July 27, 2022
Sponsor
Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT02498730
Brief Title
Interval Training in Bipolar Disorder
Acronym
HIIT
Official Title
Can the High Intensity Interval Training (HIIT) Deliver Superior and Rapid Decrease of Symptoms of Bipolar Disorder? a Controlled and Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
bipolar disorder, VO2max, aerobic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interval Training
Arm Type
Active Comparator
Arm Description
6 stimulous (30 s) at 100% VO2Max/ 1 min 30 s to rest, 19 minutes (total exercise), 3 times/ week, 12 weeks
Arm Title
Continuous Training
Arm Type
Active Comparator
Arm Description
Running at 60% VO2Max, 25 minutes (total exercise), 3 times/week, 12 weeks
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Only Dependent Variables Measures
Intervention Type
Behavioral
Intervention Name(s)
Interval Training
Other Intervention Name(s)
High intensity interval training, HIIT, HIT
Intervention Description
High Intensity Interval Training at 100% VO2Max
Intervention Type
Behavioral
Intervention Name(s)
Continuous Training
Other Intervention Name(s)
Moderate Training, Endurance
Intervention Description
Continuous Stimulous at 60% VO2Max
Intervention Type
Behavioral
Intervention Name(s)
Control
Other Intervention Name(s)
No Intervention
Intervention Description
Only Dependent Variables Measures
Primary Outcome Measure Information:
Title
Symptom Scales (Hamilton and Young)
Description
Variable Measured to reduction of symptoms
Time Frame
0 week, 6 week, 12 week
Secondary Outcome Measure Information:
Title
Cortical Changes (EEG) - Loreta
Description
Measured to evaluate changes due to training
Time Frame
0 week, 6 week, 12 week
Title
VO2Max
Description
Variable Measured to assess cardiovascular improvement
Time Frame
0 week, 6 week, 12 week
Title
Cognitive Function
Description
Executive Function, Time Reaction, Atention, and Memory
Time Frame
0 week, 6 week, 12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Bipolar Criteria (DSM-IV), sedentary lifestyle Exclusion Criteria: 60 and over, Cardiovascular Disease, Panic disorder, Metabolic syndrome Diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sérgio E. Machado, PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Psychiatry (IPUB)
City
Rio de Janeiro
Country
Brazil

12. IPD Sharing Statement

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Interval Training in Bipolar Disorder

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