High Intensity Interval Training and Hypoxic Conditioning in Obese Patients

Study Overview
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Brief Summary
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The present study aims at evaluating the effect of two innovative treatment strategies in obese patients: high intensity interval training and hypoxic conditioning. Obese patients will be randomized in groups performing high intensity interval training, constant load training, hypoxic conditioning or placebo normoxic conditioning for 8 weeks. The effects of the interventions will be measured regarding exercise tolerance, blood pressure, body composition, metabolic status.

Detailed Description
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120 obese patients will be randomized to 6 intervention groups. Each group will follow an 8-week intervention (3 session per week) with either high intensity interval training in normoxia or hypoxia, constant load exercise training in normoxia or hypoxia, hypoxic or normoxic (placebo) conditioning at rest. Exercise capacity, metabolic status, blood pressure, vascular function and physical activity will be assessed before and after the intervention.

Official Title
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New Treatment Modalities in Obese Patients: High Intensity Interval Training and Hypoxic Conditioning

Conditions
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Obesity

Intervention / Treatment
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* Other: High intensity interval training N
* Other: High intensity interval training H
* Other: Constant load exercise training N
* Other: Constant load exercise training H
* Other: Hypoxic conditioning at rest
* Other: Normoxic conditioning at rest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 27 and 35 kg/m² Physical activity <2 hours/week No chronic disease or treatment able to interfere with inflammation and metabolic perturbatiosn associated with obesity Exclusion Criteria: Diabetes mellitus treated with insulin Auto-immune or inflammatory diseases requiring long term therapy Unstable dysthyroidism Bariatric surgery within the past 18 months Tumoral, inflammatory, infectious, cardiac, respiratory, kidney, digestive disease Untreated sleep apnea

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity interval training N<br>High intensity interval training N: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a high intensity interval training protocol (1 min ON at 100% maximal power output, 1 min OFF), breathing ambient air (normoxia) | Other: High intensity interval training N<br>* Exercise training and ambient air breathing<br>|
| Experimental: High intensity interval training H<br>High intensity interval training H: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a high intensity interval training protocol (1 min ON at 100% maximal power output, 1 min OFF), breathing hypoxic air (about 3 500 m of altitude) | Other: High intensity interval training H<br>* Exercise training and hypoxic breathing<br>|
| Active Comparator: Constant load exercise training N<br>Constant load exercise training N: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a constant load training protocol (50% maximal power output), breathing ambient air (normoxia) | Other: Constant load exercise training N<br>* Exercise training and ambient air breathing<br>|
| Experimental: Constant load exercise training H<br>Constant load exercise training H: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a constant load training protocol (50% maximal power output), breathing hypoxic air (about 3 500 m of altitude) | Other: Constant load exercise training H<br>* Exercise training and hypoxic breathing<br>|
| Experimental: Hypoxic conditioning at rest<br>Hypoxic conditioning at rest : The intervention consists in 8-week conditioning period, 3 times a week, hypoxic breathing for one hour (about 4500 m of altitude) while seating quietly | Other: Hypoxic conditioning at rest<br>* Hypoxic breathing at rest<br>|
| Sham Comparator: Normoxic conditioning at rest<br>Normoxic conditioning at rest : The intervention consists in 8-week conditioning period, 3 times a week, normoxic breathing for one hour (ambient air) while seating quietly | Other: Normoxic conditioning at rest<br>* Normoxic breathing at rest (placebo)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal exercise capacity | Maximal oxygen consumption during an incremental exercise test | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic status | Blood lipids, glycemia, HOMA index, oxydative stress and inflammatory status | 8 weeks | 
| Body composition | MRI fat free mass and adipose tissue measurements | 8 weeks | 
| Blood pressure | 24 h ambulatory blood pressure mesurement | 8 weeks | 
| Vascular function | Post-ischemic hyperemia (Endo-Pat) and pulse wave velocity | 8 weeks | 
| Physical activity | Spontaneous physical activity measured by accelerometry | 8 weeks |