Abstract
BackgroundMetabolic syndrome substantially increases risk of cardiovascular events. It is therefore imperative to develop or optimize ways to prevent or attenuate this condition. Exercise training has been long recognized as a corner-stone therapy for reducing individual cardiovascular risk factors constituting the metabolic syndrome. However, the optimal exercise dose and its feasibility in a real world setting has yet to be established.The primary objective of this randomized trial is to investigate the effects of different volumes of aerobic interval training (AIT) compared to the current exercise guideline of moderate-intensity continuous training (MICT) on the composite number of cardiovascular disease risk factors constituting the metabolic syndrome after a 16 week, 1-year, and 3-year follow-up.MethodsThis is a randomized international multi-center trial including men and women aged ≥30 years diagnosed with the metabolic syndrome according to the International Diabetes Federation criteria. Recruitment began in August 2012 and concluded in December 2016. This trial consists of supervised and unsupervised phases to evaluate the efficacy and feasibility of different exercise doses on the metabolic syndrome in a real world setting. This study aims to include and randomize 465 participants to 3 years of one of the following training groups: i) 3 times/week of 4 × 4 min AIT at 85–95% peak heart rate (HRpeak); ii) 3 times/week of 1 × 4 min AIT at 85–95% HRpeak; or iii) 5–7 times/week of ≥30 min MICT at 60–70% HRpeak. Clinical examinations, physical tests and questionnaires are administered to all participants during all testing time points (baseline, 16 weeks and after 1-, and 3-years).DiscussionThis multi-center international trial indeed aims to ease the burden in healthcare/economic cost arising from treating end-stage CVD related conditions such as stroke and myocardial infarction, that could eventually emerge from the metabolic syndrome condition.Trial registrationClinical registration number: NCT01676870, ClinicalTrials.gov (August 31, 2012).
Highlights
Metabolic syndrome substantially increases risk of cardiovascular events
To our knowledge, Exercise in prevention of metabolic syndrome (EX-MET) is the first randomized trial to investigate the impact of different volumes of aerobic interval training (AIT) (1AIT and 4-AIT) and moderate-intensity continuous training (MICT) on the treatment of metabolic syndrome in individuals from different ethnic groups
This trial aims to extend previous small studies (n = 27 to 40) without a follow-up period that have examined the efficacy of high volume-AIT compared to an iso-caloric MICT on traditional and novel cardiovascular disease (CVD) risk factors [11, 16, 19, 20]
Summary
Design Participants with the metabolic syndrome defined according to the IDF-criteria [3] are included in this trial. Sample size and statistics According to estimates based on data from previous studies, [16, 17] a total 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 These calculations were based on the following assumptions: The primary endpoint is reduction in the composite number of cardiovascular risk factors constituting the metabolic syndrome (IDF) [3], as a change from baseline to one year follow-up. Participants are encouraged to purchase their own heart rate monitor to keep track of their own training during the unsupervised sessions Otherwise, they are instructed to use the Borg 6–20 scale (rating of perceived exertion) to serve as a guide towards the exercise intensity achieved [18]. RPE and HR are monitored and recorded for all training sessions as indicated above
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