Exercise in Prevention of Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exercise in Prevention of Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: 1x4 aerobic interval training
* Behavioral: 4x4 aerobic interval training
* Behavioral: traditional moderate training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1x4 aerobic interval training<br>1x4min aerobic interval training (1-AIT), 3 times a week | Behavioral: 1x4 aerobic interval training<br>* 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.<br>|
| Experimental: 4x4 aerobic interval training<br>4x4min aerobic interval training (4-AIT), vigorously exercise according to today's guidelines, 3 times a week | Behavioral: 4x4 aerobic interval training<br>* 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.<br>|
| Active Comparator: traditional moderate training<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular risk factors constituting metabolic syndrome | Endothelial function and blood pressure, biopsies from the m. vastus lateralis, Protein and expression levels, oxidized LDL and adiponectin in blood plasma | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise training, exercise therapy, physical fitness, risk factors