High Intensity Interval Training and Hypoxic Conditioning in Obese Patients (HYPINT)

March 17, 2020 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

120

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 Contact

Study Contact Backup

Study Locations

  • France
    • Rhone Alpes
      • Grenoble, Rhone Alpes, France, 38000
        • Recruiting
        • Grenoble University Hospital
        • Contact:

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High intensity interval training N
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
Exercise training and ambient air breathing
Experimental: High intensity interval training H
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
Exercise training and hypoxic breathing
Active Comparator: Constant load exercise training N
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
Exercise training and ambient air breathing
Experimental: Constant load exercise training H
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
Exercise training and hypoxic breathing
Experimental: Hypoxic conditioning at rest
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
Hypoxic breathing at rest
Sham Comparator: Normoxic conditioning at rest
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
Normoxic breathing at rest (placebo)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Bernard Wuyam, MD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 1, 2015

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

December 24, 2015

First Submitted That Met QC Criteria

December 24, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01482-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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