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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High intensity interval training N
High intensity interval training H
Constant load exercise training N
Constant load exercise training H
Hypoxic conditioning at rest
Normoxic conditioning at rest
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grenoble University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Sham Comparator

Arm Label

High intensity interval training N

High intensity interval training H

Constant load exercise training N

Constant load exercise training H

Hypoxic conditioning at rest

Normoxic conditioning at rest

Arm Description

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)

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)

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)

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)

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

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

Outcomes

Primary Outcome Measures

Maximal exercise capacity
Maximal oxygen consumption during an incremental exercise test

Secondary Outcome Measures

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

Full Information

First Posted
December 24, 2015
Last Updated
March 17, 2020
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02642705
Brief Title
High Intensity Interval Training and Hypoxic Conditioning in Obese Patients
Acronym
HYPINT
Official Title
New Treatment Modalities in Obese Patients: High Intensity Interval Training and Hypoxic Conditioning
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High intensity interval training N
Arm Type
Experimental
Arm Description
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)
Arm Title
High intensity interval training H
Arm Type
Experimental
Arm Description
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)
Arm Title
Constant load exercise training N
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Constant load exercise training H
Arm Type
Experimental
Arm Description
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)
Arm Title
Hypoxic conditioning at rest
Arm Type
Experimental
Arm Description
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
Arm Title
Normoxic conditioning at rest
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
High intensity interval training N
Intervention Description
Exercise training and ambient air breathing
Intervention Type
Other
Intervention Name(s)
High intensity interval training H
Intervention Description
Exercise training and hypoxic breathing
Intervention Type
Other
Intervention Name(s)
Constant load exercise training N
Intervention Description
Exercise training and ambient air breathing
Intervention Type
Other
Intervention Name(s)
Constant load exercise training H
Intervention Description
Exercise training and hypoxic breathing
Intervention Type
Other
Intervention Name(s)
Hypoxic conditioning at rest
Intervention Description
Hypoxic breathing at rest
Intervention Type
Other
Intervention Name(s)
Normoxic conditioning at rest
Intervention Description
Normoxic breathing at rest (placebo)
Primary Outcome Measure Information:
Title
Maximal exercise capacity
Description
Maximal oxygen consumption during an incremental exercise test
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Metabolic status
Description
Blood lipids, glycemia, HOMA index, oxydative stress and inflammatory status
Time Frame
8 weeks
Title
Body composition
Description
MRI fat free mass and adipose tissue measurements
Time Frame
8 weeks
Title
Blood pressure
Description
24 h ambulatory blood pressure mesurement
Time Frame
8 weeks
Title
Vascular function
Description
Post-ischemic hyperemia (Endo-Pat) and pulse wave velocity
Time Frame
8 weeks
Title
Physical activity
Description
Spontaneous physical activity measured by accelerometry
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel Verges, PhD
Phone
0476766860
Email
sverges@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Patrice Flore, PhD
Phone
0476768921
Email
pflore@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Wuyam, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble University Hospital
City
Grenoble
State/Province
Rhone Alpes
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Verges, PhD
Phone
0476766860
Email
sverges@chu-grenoble.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26157787
Citation
Verges S, Chacaroun S, Godin-Ribuot D, Baillieul S. Hypoxic Conditioning as a New Therapeutic Modality. Front Pediatr. 2015 Jun 22;3:58. doi: 10.3389/fped.2015.00058. eCollection 2015.
Results Reference
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PubMed Identifier
24144531
Citation
Weston KS, Wisloff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21.
Results Reference
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High Intensity Interval Training and Hypoxic Conditioning in Obese Patients

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