Exercise in Prevention of Metabolic Syndrome (EX-MET)
|ClinicalTrials.gov Identifier: NCT01676870|
Recruitment Status : Active, not recruiting
First Posted : August 31, 2012
Last Update Posted : April 9, 2018
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 or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Behavioral: 1x4 aerobic interval training Behavioral: 4x4 aerobic interval training Behavioral: traditional moderate training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||465 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exercise in Prevention of Metabolic Syndrome|
|Actual Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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).
- cardiovascular risk factors constituting metabolic syndrome [ Time Frame: up to 3 years ]Endothelial function and blood pressure, biopsies from the m. vastus lateralis, Protein and expression levels, oxidized LDL and adiponectin in blood plasma
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676870
|School of Human Movement Studies, University of Queensland|
|St Lucia, Australia|
|University of Sao Paulo|
|São Paulo, Brazil|
|Internal Medicine, Cardiology, Sports Medicine Chair Dep. Prevention, Rehabilitation and Sports Medicine Faculty of Medicine University Hospital|
|Stavanger University Hospital|
|St. Olavs hospital|
|Study Director:||Ulrik Wisløff, PhD prof||Norwegian University of Science and Technology|