Exercise Training and Fitness in Severe Obesity

NCT ID: NCT02254200

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-01-31

Brief Summary

Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to be linked with an impaired ability to oxidize lipids, particularly in class III obese individuals [Body Mass Index (BMI): > 40 kg*m-2]. Exercise training is an effective strategy to improve insulin sensitivity and to reduce the risk of type 2 diabetes.

This study aimed to compare the effects of two different 2-wk-long training modalities [continuous at the intensity eliciting the maximal fat oxidation (Fatmax) versus adapted high intensity interval training (HIIT)] on aerobic and metabolic fitness of class II and III obese men. It was hypothesized that, because of the nature of HIIT in the stimulation of rapid changes, aerobic fitness, fat oxidation rates during exercise and insulin sensitivity would be improved to a greater extent when adapted HIIT compared to Fatmax training.

Detailed Description

Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to be linked with an impaired ability to oxidize lipids, particularly in class III obese individuals [Body Mass Index (BMI): > 40 kg*m-2] (1). Exercise training is an effective strategy to improve insulin sensitivity and to reduce the risk of type 2 diabetes (2). It has been suggested that 8 (3) or 10 wk (4) of an individualized moderate exercise training program at intensity (Fatmax) that elicits maximal fat oxidation (MFO) may significantly increase the fat oxidation rates (FORs) during exercise; it may also increase the muscle oxidative capacity in overweight and class I obese men. The effects of an individualized Fatmax training program of a shorter duration have never been investigated.

High-intensity interval training (Wingate-based HIIT) has been shown to induce similar adaptations as traditional training at a moderate intensity following 6 wk of training in healthy adults despite the lower training volume (5). This suggests that HIIT may be a time-efficient alternative (6). Recently, HIIT was also reported to rapidly induce adaptations that are linked to improved health-related outcomes in sedentary and overweight/obese individuals (7, 8).

This study aimed to compare the effects of two different 2-wk-long training modalities [continuous at the intensity eliciting the maximal fat oxidation (Fatmax) versus adapted high intensity interval training (HIIT)] on aerobic and metabolic fitness of class II and III obese men. It was hypothesized that, because of the nature of HIIT in the stimulation of rapid changes, aerobic fitness, fat oxidation rates during exercise and insulin sensitivity would be improved to a greater extent when trained with adapted HIIT compared to Fatmax training.

A group of twenty obese men (BMI≥35 kg*m-2) will be assigned to Fatmax group or to adapted HIIT group. Both groups will perform 8 cycling-sessions matched for mechanical work spread over 14 days [40-50 min continuous exercise at ~60-70% of the maximal heart rate (Fatmax) or 10x60-s cycling intervals a ~90% maximal heart rate interspersed with 60-s recovery (HIIT)]. Aerobic fitness and fat oxidation rates (FORs) during exercise will be assessed prior to and following the training with a maximal incremental test. Blood samples will also be drawn to determine hormones and plasma metabolites levels. Insulin sensitivity was assessed by the homeostasis model assessment of insulin resistance (HOMA).

The experimental design will consist of the following: 1) maximal ramp incremental test, to determine peak power output of each subject. 2) pre training test with blood samples, maximal incremental test (Incr) to determine the whole-body fat oxidation kinetics and Fatmax in the first phase (IncrP1) and the maximal parameters in the second phase (IncrP2) of the test. 3) 2-wk training intervention, Fatmax or HIIT and 4) post-training test, control maximal incremental test with blood samples.

A 3-way repeated-measures ANOVA (time x group x exercise intensity) will be performed to compare the investigated variables.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fatmax group

Group who performed a continuous training program at the intensity eliciting the maximal fat oxidation

Group Type: EXPERIMENTAL

Fatmax group

Intervention Type: OTHER

For the Fatmax group each session will consist of 40-50 min of continuous exercise with an intensity that corresponded to the individual Fatmax (moderate intensity)

HIIT group

Group who performed a continuous training program with high intensity interval

Group Type: EXPERIMENTAL

HIIT group

Intervention Type: OTHER

For HIIT group, each session will consist of 10x60-s cycling intervals interspersed with 60-s of recovery. The workloads will be selected to elicit a heart rate of \~90% maximal heart rate during the intervals with a pedal rate of 90-100 revolutions.min-1, whereas during recovery, the participants will be allowed to pedal against a resistance of 50 W

Interventions

Fatmax group

For the Fatmax group each session will consist of 40-50 min of continuous exercise with an intensity that corresponded to the individual Fatmax (moderate intensity)

Intervention Type: OTHER

HIIT group

For HIIT group, each session will consist of 10x60-s cycling intervals interspersed with 60-s of recovery. The workloads will be selected to elicit a heart rate of \~90% maximal heart rate during the intervals with a pedal rate of 90-100 revolutions.min-1, whereas during recovery, the participants will be allowed to pedal against a resistance of 50 W

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI ≥ 35 kg*m-2

Exclusion Criteria

• Hypertension (blood pressure > 130/90)
• Impaired fasting glucose (> 6.1 mmol*L-1)
• Type 2 diabetes
• Abnormal ECG readings at rest

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lausanne

OTHER

Sponsor Role: collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefano Lanzi, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne, Department of Physiology

Alberto Salvadori, MD

Role: STUDY_DIRECTOR

Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

Franco Codecasa, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

Mauro Cornacchia, MD

Role: STUDY_CHAIR

Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

Davide Malatesta, PhD

Role: STUDY_DIRECTOR

University of Lausanne, Institute of Sport Sciences

Paolo Fanari, MD

Role: STUDY_CHAIR

Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

Locations

Istituto Auxologico Italiano, Ospedale San Giuseppe

Verbania, VB, Italy

Countries

Italy

References

Houmard JA. Intramuscular lipid oxidation and obesity. Am J Physiol Regul Integr Comp Physiol. 2008 Apr;294(4):R1111-6. doi: 10.1152/ajpregu.00396.2007. Epub 2008 Feb 6.

Reference Type: BACKGROUND

PMID: 18256136 (View on PubMed)

Houmard JA, Tanner CJ, Slentz CA, Duscha BD, McCartney JS, Kraus WE. Effect of the volume and intensity of exercise training on insulin sensitivity. J Appl Physiol (1985). 2004 Jan;96(1):101-6. doi: 10.1152/japplphysiol.00707.2003. Epub 2003 Sep 12.

Reference Type: BACKGROUND

PMID: 12972442 (View on PubMed)

Dumortier M, Brandou F, Perez-Martin A, Fedou C, Mercier J, Brun JF. Low intensity endurance exercise targeted for lipid oxidation improves body composition and insulin sensitivity in patients with the metabolic syndrome. Diabetes Metab. 2003 Nov;29(5):509-18. doi: 10.1016/s1262-3636(07)70065-4.

Reference Type: BACKGROUND

PMID: 14631328 (View on PubMed)

Bordenave S, Metz L, Flavier S, Lambert K, Ghanassia E, Dupuy AM, Michel F, Puech-Cathala AM, Raynaud E, Brun JF, Mercier J. Training-induced improvement in lipid oxidation in type 2 diabetes mellitus is related to alterations in muscle mitochondrial activity. Effect of endurance training in type 2 diabetes. Diabetes Metab. 2008 Apr;34(2):162-8. doi: 10.1016/j.diabet.2007.11.006.

Reference Type: BACKGROUND

PMID: 18396088 (View on PubMed)

Burgomaster KA, Howarth KR, Phillips SM, Rakobowchuk M, Macdonald MJ, McGee SL, Gibala MJ. Similar metabolic adaptations during exercise after low volume sprint interval and traditional endurance training in humans. J Physiol. 2008 Jan 1;586(1):151-60. doi: 10.1113/jphysiol.2007.142109. Epub 2007 Nov 8.

Reference Type: BACKGROUND

PMID: 17991697 (View on PubMed)

Whyte LJ, Gill JM, Cathcart AJ. Effect of 2 weeks of sprint interval training on health-related outcomes in sedentary overweight/obese men. Metabolism. 2010 Oct;59(10):1421-8. doi: 10.1016/j.metabol.2010.01.002. Epub 2010 Feb 12.

Reference Type: BACKGROUND

PMID: 20153487 (View on PubMed)

Trilk JL, Singhal A, Bigelman KA, Cureton KJ. Effect of sprint interval training on circulatory function during exercise in sedentary, overweight/obese women. Eur J Appl Physiol. 2011 Aug;111(8):1591-7. doi: 10.1007/s00421-010-1777-z. Epub 2010 Dec 29.

Reference Type: BACKGROUND

PMID: 21190036 (View on PubMed)

Lanzi S, Codecasa F, Cornacchia M, Maestrini S, Capodaglio P, Brunani A, Fanari P, Salvadori A, Malatesta D. Short-term HIIT and Fat max training increase aerobic and metabolic fitness in men with class II and III obesity. Obesity (Silver Spring). 2015 Oct;23(10):1987-94. doi: 10.1002/oby.21206. Epub 2015 Sep 3.

Reference Type: DERIVED

PMID: 26335027 (View on PubMed)

Other Identifiers

06C301

Identifier Type: -

Identifier Source: org_study_id