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Exercise in Prevention of Metabolic Syndrome (EX-MET)

This study is currently recruiting participants.
Verified October 2012 by Norwegian University of Science and Technology
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01676870
First received: August 29, 2012
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

The primary objective of the study is to compare in a real-world setting the efficacy of traditional training (today's guideline, vigorously or moderate exercise) and amount of aerobic interval training (1-AIT) in reduction of risk factors constituting metabolic syndrome.

The secondary objective is to compare the efficacy of traditional moderate training (today's guideline) and amount of aerobic interval training (1-AIT vs. 4-AIT) in improving aerobic capacity, cardiovascular function, skeletal muscle contractile function, skeletal muscle energy metabolism, left ventricle systolic and diastolic function at rest and right ventricular function.

The investigators hypothesized that aerobic interval training would reverse features of the metabolic syndrome more than traditional training.


Condition Intervention
Metabolic Syndrome
 Behavioral: 1x4 aerobic interval training
Behavioral: 4x4 aerobic interval training
Behavioral: traditional moderate training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Exercise in Prevention of Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • cardiovascular risk factors constituting metabolic syndrome [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Endothelial function and blood pressure, biopsies from the m. vastus lateralis, Protein and expression levels, oxidized LDL and adiponectin in blood plasma


Estimated Enrollment: 750
Study Start Date: January 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1x4 aerobic interval training
1x4min aerobic interval training (1-AIT), 3 times a week
 Behavioral: 1x4 aerobic interval training
endurance training as walking/running "uphill" 3 times/week for 16 weeks (2 supervised sessions (treadmill) and 1 at home each week) at 90% of Hfmax. Warm-up 10 min at 70% of maximal heart frequency (Hfmax), 5min cool-down.
Experimental: 4x4 aerobic interval training
4x4min aerobic interval training (4-AIT), vigorously exercise according to today's guidelines, 3 times a week
 Behavioral: 4x4 aerobic interval training
endurance training as walking/running "uphill" 3 times/week for 16 weeks (2 supervised sessions (treadmill) and 1 at home each week) at 90% of Hfmax. Warm-up 10 min at 70% of maximal heart frequency (Hfmax), 3 min active pause between each interval, 5min cool-down.
Active Comparator: traditional moderate training
traditional moderate training (CME), moderate exercise at least 30 min, 5 days a week or more, according to today's guidelines
 Behavioral: traditional moderate training
moderate intensity treadmill training (50-70% of HRmax) for a minimum of 30min, 5 times a week for 16 weeks (2 supervised sessions and 3 or more home).

Detailed Description:

This study describes a randomized multicenter clinical trial designed to test the hypothesis that a 16-week program, with one year follow up of vigorously exercise defined from today's guidelines (performed as 4-AIT (4x4min aerobe interval training)) yields larger beneficial effects in reducing risk factors constituting the metabolic syndrome than continuously moderate intensity exercise (CME) defined from today's guidelines.

Furthermore, the importance of the amount of aerobic interval training remains unclear and it is unknown how little "one can get away with" and still obtain substantial beneficial cardiovascular effects. Therefore, the investigators will also determine whether one bout of AIT (1-AIT (1x4min aerobe interval training)) can give beneficial effects compared to 4-AIT and CME.

Evaluation criteria are risk factors constituting metabolic syndrome, aerobic capacity measured as peak oxygen uptake and compliance to intervention. Assessments will be made before and after the 16-week program, and at six month, and 1 and 3 years follow-up. Calculations based on previously results suggest a total number of 750 patients randomized 1:1:1 (250 in each group) to the three intervention groups is sufficient to detect larger beneficial effects with AIT with a p-value of 0.05 (two-sided test) and statistical power of 0.85 (primary endpoint is reduction in cardiovascular risk factors constituting metabolic syndrome).

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • metabolic syndrome defined according to the IDF-criteria

Exclusion Criteria:

  • unstable angina
  • recent cardiac infarction (4weeks)
  • uncompensated heart failure
  • severe valvular illness
  • pulmonary disease
  • uncontrolled hypertension
  • kidney failure
  • orthopedic/neurological limitations
  • cardiomyopathy
  • planned operations during the research period
  • reluctant to sign the consent form
  • drug or alcohol abuse
  • participants in a parallel study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676870

Contacts
Contact: Arnt E Tjønna, PhD +4772828358 arnt.e.tjonna@ntnu.no

Locations
Australia
School of Human Movement Studies, University of Queensland Recruiting
St Lucia, Australia
Contact: Jeff Coombe            
Germany
Internal Medicine, Cardiology, Sports Medicine Chair Dep. Prevention, Rehabilitation and Sports Medicine Faculty of Medicine University Hospital Recruiting
Munich, Germany
Contact: Martin Halle            
Norway
Levanger Hospital and University college Recruiting
Levanger, Norway
Contact: Håvard Dahlen            
Sub-Investigator: Boye Welde            
Sub-Investigator: Terje Dalen            
St. Olavs hospital Recruiting
Trondheim, Norway
Contact: Arnt E Tjønna, PhD     +4772828358     arnt.e.tjonna@ntnu.no    
Contact: Ulrik Wisløff, PhD prof     +4772828113     ulrik.wisloff@ntnu.no    
Tunisia
Institut National de Nutrition, Recruiting
Tunis, Tunisia
Contact: Latifa Beltaifa            
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Director: Ulrik Wisløff, PhD prof Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01676870     History of Changes
Other Study ID Numbers: 2011/1230
Study First Received: August 29, 2012
Last Updated: October 22, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
exercise training
exercise therapy
physical fitness
risk factors

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013