Interval Training in Bipolar Disorder

Study Overview
=================
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.

Official Title
-----------------
Can the High Intensity Interval Training (HIIT) Deliver Superior and Rapid Decrease of Symptoms of Bipolar Disorder? a Controlled and Randomized Study

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Behavioral: Interval Training
* Behavioral: Continuous Training
* Behavioral: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar Criteria (DSM-IV), sedentary lifestyle Exclusion Criteria: 60 and over, Cardiovascular Disease, Panic disorder, Metabolic syndrome Diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interval Training<br>6 stimulous (30 s) at 100% VO2Max/ 1 min 30 s to rest, 19 minutes (total exercise), 3 times/ week, 12 weeks | Behavioral: Interval Training<br>* High Intensity Interval Training at 100% VO2Max<br>* Other names: HIT;Behavioral: Continuous Training<br>* Continuous Stimulous at 60% VO2Max<br>* Other names: Endurance;|
| Active Comparator: Continuous Training<br>Running at 60% VO2Max, 25 minutes (total exercise), 3 times/week, 12 weeks | Behavioral: Interval Training<br>* High Intensity Interval Training at 100% VO2Max<br>* Other names: HIT;Behavioral: Continuous Training<br>* Continuous Stimulous at 60% VO2Max<br>* Other names: Endurance;|
| Sham Comparator: Control<br>Only Dependent Variables Measures | Behavioral: Control<br>* Only Dependent Variables Measures<br>* Other names: No Intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Scales (Hamilton and Young) | 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 | Measured to evaluate changes due to training | 0 week, 6 week, 12 week | 
| VO2Max | Variable Measured to assess cardiovascular improvement | 0 week, 6 week, 12 week | 
| Cognitive Function | Executive Function, Time Reaction, Atention, and Memory | 0 week, 6 week, 12 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VO2max, aerobic exercise, bipolar disorder