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Exercise Training and Fitness in Severe Obesity (INTFMOBE)

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ClinicalTrials.gov Identifier: NCT02254200
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : July 21, 2015
Sponsor:
Collaborator:
University of Lausanne
Information provided by (Responsible Party):
Istituto Auxologico Italiano

Tracking Information
First Submitted Date  ICMJE September 29, 2014
First Posted Date  ICMJE October 1, 2014
Last Update Posted Date July 21, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
  • Maximal Oxygen consumption (VO2 max) [ Time Frame: After two-wk-long of Fatmax or HIIT traning ]
    VO2 max at incremental test performed at the end of Fatmax or HIIT training period
  • Fat oxidation rates (FORs) [ Time Frame: After two-wk-long of Fatmax or HIIT traning ]
    FORs at incremental test performed at the end of Fatmax or HIIT training period
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • VO2 max [ Time Frame: After two-wk-long of Fatmax or HIIT traning ]
    VO2 max at incremental test performed at the end of Fatmax or HIIT training period
  • Fat oxidation rates (FORs) [ Time Frame: After two-wk-long of Fatmax or HIIT traning ]
    FORs at incremental test performed at the end of Fatmax or HIIT training period
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • HOMA-IR [ Time Frame: After two-wk-long of Fatmax or HIIT traning ]
    Insulin sensitivity assessed by homeostasis model assessment of insulin resistance (HOMA-IR) at the end of Fatmax or HIIT training period
  • Non-esterified fatty acid (NEFA) [ Time Frame: After two-wk-long of Fatmax or HIIT traning ]
    Resting NEFA at the end of Fatmax or HIIT training period
  • Insulin [ Time Frame: After two-wk-long of Fatmax or HIIT traning ]
    Resting Insulin at the end of Fatmax or HIIT training period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Training and Fitness in Severe Obesity
Official Title  ICMJE Effect of Short-term High-intensity Interval and Fatmax Training on Aerobic and Metabolic Fitness in Obese Subjects
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Other: 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)
  • 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
Study Arms  ICMJE
  • Experimental: Fatmax group
    Group who performed a continuous training program at the intensity eliciting the maximal fat oxidation
    Intervention: Other: Fatmax group
  • Experimental: HIIT group
    Group who performed a continuous training program with high intensity interval
    Intervention: Other: HIIT group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2014)
19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02254200
Other Study ID Numbers  ICMJE 06C301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Istituto Auxologico Italiano
Study Sponsor  ICMJE Istituto Auxologico Italiano
Collaborators  ICMJE University of Lausanne
Investigators  ICMJE
Principal Investigator: Stefano Lanzi, MSc University of Lausanne, Department of Physiology
Study Director: Alberto Salvadori, MD Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
Principal Investigator: Franco Codecasa, MD Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
Study Chair: Mauro Cornacchia, MD Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
Study Director: Davide Malatesta, PhD University of Lausanne, Institute of Sport Sciences
Study Chair: Paolo Fanari, MD Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
PRS Account Istituto Auxologico Italiano
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP