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High-intensity Intermittent Training for Obese Individuals

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High intensity training
short springs
Moderate intensity exercise
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, exercise, body composition, insulin sensitivity, appetite, food intake

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Moderate intensity exercise

High Intensity training

Short springs

Arm Description

Moderate intensity exercise

High Intensity intermittent training

short springs training

Outcomes

Primary Outcome Measures

Changes in body composition
Body composition assessed by DEXA

Secondary Outcome Measures

Changes in insulin sensitivity
Insulin will be measured in fasting and for 3h after a test meal

Full Information

First Posted
June 2, 2010
Last Updated
April 19, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Midt-Norge
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1. Study Identification

Unique Protocol Identification Number
NCT01143376
Brief Title
High-intensity Intermittent Training for Obese Individuals
Official Title
High-intensity Intermittent Training to Maximize Metabolic and Cardiovascular Protection in Obese Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Midt-Norge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, exercise, body composition, insulin sensitivity, appetite, food intake

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate intensity exercise
Arm Type
Active Comparator
Arm Description
Moderate intensity exercise
Arm Title
High Intensity training
Arm Type
Experimental
Arm Description
High Intensity intermittent training
Arm Title
Short springs
Arm Type
Experimental
Arm Description
short springs training
Intervention Type
Behavioral
Intervention Name(s)
High intensity training
Intervention Description
high-intensity intermittent sprinting (HIIS) (8 sec sprint:12 sec rest) for 12 weeks, 4 times a week
Intervention Type
Behavioral
Intervention Name(s)
short springs
Intervention Description
short duration sprints (SDS)(8 sec sprint:12 sec rest) for 12 weeks, 4 times a week
Intervention Type
Behavioral
Intervention Name(s)
Moderate intensity exercise
Primary Outcome Measure Information:
Title
Changes in body composition
Description
Body composition assessed by DEXA
Time Frame
Baseline and after 12 weeks of training
Secondary Outcome Measure Information:
Title
Changes in insulin sensitivity
Description
Insulin will be measured in fasting and for 3h after a test meal
Time Frame
Baseline and after 12 weeks of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catia Martins, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
7489
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26479856
Citation
Martins C, Kazakova I, Ludviksen M, Mehus I, Wisloff U, Kulseng B, Morgan L, King N. High-Intensity Interval Training and Isocaloric Moderate-Intensity Continuous Training Result in Similar Improvements in Body Composition and Fitness in Obese Individuals. Int J Sport Nutr Exerc Metab. 2016 Jun;26(3):197-204. doi: 10.1123/ijsnem.2015-0078. Epub 2015 Oct 19.
Results Reference
result
PubMed Identifier
28398946
Citation
Martins C, Aschehoug I, Ludviksen M, Holst J, Finlayson G, Wisloff U, Morgan L, King N, Kulseng B. High-Intensity Interval Training, Appetite, and Reward Value of Food in the Obese. Med Sci Sports Exerc. 2017 Sep;49(9):1851-1858. doi: 10.1249/MSS.0000000000001296.
Results Reference
result

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High-intensity Intermittent Training for Obese Individuals

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