High-intensity Intermittent Training for Obese Individuals

April 19, 2017 updated by: Norwegian University of Science and Technology

High-intensity Intermittent Training to Maximize Metabolic and Cardiovascular Protection in Obese Individuals

The most appropriate and effective exercise interventions for weight loss remain a matter of continued discussion and there is a need to identify sustainable exercise programs which successfully promote weight loss and benefit health.

The primary objective of this study is to determine if high-intensity intermittent sprinting (HIIS) produces better results in terms of reducing metabolic and cardiovascular risk factors, with special emphasis to fat mass loss and insulin sensitivity in "healthy" obese volunteers compared with an iso-caloric program of moderate-intensity continuous cycling (MICC) (control condition following the international recommendations). We will also assess the impact of short duration sprints (SDS) in the above factors and to understand the potential mechanisms behind different outcomes among training programs.

The overall hypothesis is that HIIS will lead to a greater reduction in metabolic and cardiovascular risk factors compared with MICC in healthy obese volunteers and that SDS will produce similar improvements in cardiovascular risk factors as the longer duration HIIS

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomized to one of three groups: HIIS (8s sprint:12s rest) or MICC (control group) iso-caloric protocols (for the duration needed to induce a 250 kcal energy deficit) or SDS (8s sprint:12s rest) for 10 minutes for 12 weeks. The intervention groups will be matched for age, BMI and male/females ratio and participants will be asked not to change their normal diet throughout the study.

Before and after the exercise intervention (12 weeks), participants will perform the following assessments:

  1. Three-day food diaries
  2. Anthropometric measurements (weight, height, waist and hips) using standard procedures;
  3. Body composition using dual energy x-ray absorptiometry (DEXA)
  4. RMR and resting respiratory exchange ratio (RER) using indirect calorimetry;
  5. Endothelial function assessed by flow-mediated dilation (FMD) of the brachial artery using vascular ultrasound according to current guidelines;
  6. Maximal oxygen uptake (VO2max) and fat oxidation, cardiac output and left ventricular function during exercise using a cycle ergometer;
  7. Muscle and fat biopsies
  8. Fasting and postprandial release of appetite related hormones (and subjective feelings of hunger/fullness using visual analogue scales - VAS).

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7489
        • Norwegian University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • weight stable on the last three months,
  • not currently dieting to lose weight
  • inactive lifestyle.

Exclusion Criteria:

  • History of endocrine/cardiovascular/pulmonary/kidney disease,
  • anaemia,
  • gout,
  • depression or other psychological disorders,
  • eating disorders,
  • drug or alcohol abuse within the last two years
  • current medication known to affect appetite or induce weight loss.
  • planned surgery during the study period
  • participation in another research study
  • restraint score derived from the TFEQ>12
  • post-menopausal women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Moderate intensity exercise
Behavioral: Moderate intensity exercise
Experimental: High Intensity training
High Intensity intermittent training
Behavioral: High intensity training
high-intensity intermittent sprinting (HIIS) (8 sec sprint:12 sec rest) for 12 weeks, 4 times a week
Experimental: Short springs
short springs training
Behavioral: short springs
short duration sprints (SDS)(8 sec sprint:12 sec rest) for 12 weeks, 4 times a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body composition
Time Frame: Baseline and after 12 weeks of training
Body composition assessed by DEXA
Baseline and after 12 weeks of training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in insulin sensitivity
Time Frame: Baseline and after 12 weeks of training
Insulin will be measured in fasting and for 3h after a test meal
Baseline and after 12 weeks of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Helse Midt-Norge

Investigators

  • Principal Investigator: Catia Martins, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (Estimate)

June 14, 2010

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/447

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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