Completed

EX-METExercise in Prevention of Metabolic Syndrome

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What is being tested

1x4 aerobic interval training

+ 4x4 aerobic interval training

+ traditional moderate training

Behavioral
Who is being recruted

Hyperinsulinism+3

+ Insulin Resistance

+ Metabolic Diseases

From 30 to 70 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorNorwegian University of Science and Technology
Last updated: February 7, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

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 aerobe interval training (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. According to estimates based on data from previously studies, 3, 4 a total number of 465 patients randomized 1:1:1 to the three interventions gives 80% power to detect an effect of 4-AIT compared to 1-AIT/CME of 51% recovery versus 37% recovery from metabolic syndrome at the 5% significance level.

Principal SponsorNorwegian University of Science and Technology
Last updated: February 7, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

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

408 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperinsulinismInsulin ResistanceMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersMetabolic Syndrome

Criteria

1 inclusion criteria required to participate
metabolic syndrome defined according to the IDF-criteria

13 exclusion criteria prevent from participating
cardiomyopathy

drug or alcohol abuse

kidney failure

orthopedic/neurological limitations

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
1x4min aerobic interval training (1-AIT), 3 times a week

Group II

Experimental
4x4min aerobic interval training (4-AIT), vigorously exercise according to today's guidelines, 3 times a week

Group III

Active Comparator
traditional moderate training (CME), moderate exercise at least 30 min, 5 days a week or more, according to today's guidelines

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

School of Human Movement Studies, University of Queensland

Saint Lucia, AustraliaOpen School of Human Movement Studies, University of Queensland in Google Maps

University of Sao Paulo

São Paulo, Brazil

KJ Fisioterapi

Guayaquil, Ecuador

Internal Medicine, Cardiology, Sports Medicine Chair Dep. Prevention, Rehabilitation and Sports Medicine Faculty of Medicine University Hospital

Munich, Germany
Completed6 Study Centers