Exercise in Prevention of Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): 1x4 aerobic interval training; 4x4 aerobic interval training; traditional moderate training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: exercise training; exercise therapy; physical fitness; risk factors