High-intensity Intermittent Training for Obese Individuals

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Helse Midt-Norge
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01143376
First received: June 2, 2010
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Obesity
Behavioral: High intensity training
Behavioral: short springs
Behavioral: Moderate intensity exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High-intensity Intermittent Training to Maximize Metabolic and Cardiovascular Protection in Obese Individuals

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Changes in body composition [ Time Frame: Baseline and after 12 weeks of training ] [ Designated as safety issue: No ]
    Body composition assessed by DEXA


Secondary Outcome Measures:
  • Changes in insulin sensitivity [ Time Frame: Baseline and after 12 weeks of training ] [ Designated as safety issue: No ]
    Insulin will be measured in fasting and for 3h after a test meal


Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: August 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Moderate intensity exercise
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

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).
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143376

Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
Helse Midt-Norge
Investigators
Principal Investigator: Catia Martins, PhD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01143376     History of Changes
Other Study ID Numbers: 2010/447
Study First Received: June 2, 2010
Last Updated: April 16, 2014
Health Authority: Norway: Ethics Committee

Keywords provided by Norwegian University of Science and Technology:
Obesity
exercise
body composition
insulin sensitivity
appetite
food intake

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014