High Intensity Interval Training and Hypoxic Conditioning in Obese Patients

NCT ID: NCT02642705

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2021-04-30

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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type EXPERIMENTAL

High intensity interval training N

Intervention Type OTHER

Exercise training and ambient air breathing

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)

Group Type EXPERIMENTAL

High intensity interval training H

Intervention Type OTHER

Exercise training and hypoxic breathing

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)

Group Type ACTIVE_COMPARATOR

Constant load exercise training N

Intervention Type OTHER

Exercise training and ambient air breathing

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)

Group Type EXPERIMENTAL

Constant load exercise training H

Intervention Type OTHER

Exercise training and hypoxic breathing

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

Group Type EXPERIMENTAL

Hypoxic conditioning at rest

Intervention Type OTHER

Hypoxic breathing at rest

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

Group Type SHAM_COMPARATOR

Normoxic conditioning at rest

Intervention Type OTHER

Normoxic breathing at rest (placebo)

Interventions

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High intensity interval training N

Exercise training and ambient air breathing

Intervention Type OTHER

High intensity interval training H

Exercise training and hypoxic breathing

Intervention Type OTHER

Constant load exercise training N

Exercise training and ambient air breathing

Intervention Type OTHER

Constant load exercise training H

Exercise training and hypoxic breathing

Intervention Type OTHER

Hypoxic conditioning at rest

Hypoxic breathing at rest

Intervention Type OTHER

Normoxic conditioning at rest

Normoxic breathing at rest (placebo)

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard Wuyam, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Grenoble University Hospital

Grenoble, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Samuel Verges, PhD

Role: CONTACT

0476766860

Patrice Flore, PhD

Role: CONTACT

0476768921

Facility Contacts

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Samuel Verges, PhD

Role: primary

0476766860

References

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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.

Reference Type BACKGROUND
PMID: 26157787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24144531 (View on PubMed)

Other Identifiers

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2014-A01482-45

Identifier Type: -

Identifier Source: org_study_id

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