High Intensity Interval Training and Hypoxic Conditioning in Obese Patients

NCT02642705 | Unknown

• 1 other identifier: 2014-A01482-45
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Maximal exercise capacity

  Maximal oxygen consumption during an incremental exercise test

  8 weeks

Secondary Outcomes (5)

• Metabolic status

  8 weeks

• Body composition

  8 weeks

• Blood pressure

  8 weeks

• Vascular function

  8 weeks

• Physical activity

  8 weeks

Study Arms (6)

High intensity interval training N

EXPERIMENTAL

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

High intensity interval training H

EXPERIMENTAL

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

Constant load exercise training N

ACTIVE COMPARATOR

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

Constant load exercise training H

EXPERIMENTAL

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

Hypoxic conditioning at rest

EXPERIMENTAL

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

Normoxic conditioning at rest

SHAM COMPARATOR

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

Interventions

High intensity interval training N OTHER

Exercise training and ambient air breathing

High intensity interval training N

High intensity interval training H OTHER

Exercise training and hypoxic breathing

High intensity interval training H

Constant load exercise training N OTHER

Exercise training and ambient air breathing

Constant load exercise training N

Constant load exercise training H OTHER

Exercise training and hypoxic breathing

Constant load exercise training H

Hypoxic conditioning at rest OTHER

Hypoxic breathing at rest

Hypoxic conditioning at rest

Normoxic conditioning at rest OTHER

Normoxic breathing at rest (placebo)

Normoxic conditioning at rest

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

Grenoble, Auvergne-Rhône-Alpes, 38000, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 26157787 BACKGROUND

• 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.

  PMID: 24144531 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernard Wuyam, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Verges, PhD

CONTACT

0476766860; sverges@chu-grenoble.fr

Patrice Flore, PhD

CONTACT

0476768921; pflore@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: December 30, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)