High-intensity Interval, Low Volume Training in Metabolic Syndrome
Condition: Metabolic Syndrome; Insulin Resistance
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      The primary objective of the study is to compare the efficacy of an intervention with
      high-intensity interval, low volume training (HIIT-LV) or continuous aerobic exercise (CAE)
      on insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function in
      adults with metabolic syndrome (MS).

      The secondary objective is to compare the efficacy of an intervention with HIIT-LV or CAE on
      glycosylated hemoglobin, mass and muscle fibre type composition of right thigh and plasma
      levels of musclin and apelin in adults with MS.

      The investigators hypothesized that HIIT-LV is more effective in decreasing insulin
      resistance and glycosylated hemoglobin and plasma concentrations of musclin and increasing
      plasma concentrations of apelin, and both mass and muscle fibre type I percentage in thigh,
      than CAE.
    

Detailed description: 
      This study is a randomized, controlled, masked (single blind, outcomes assessor) clinical
      trial, with allocation by the minimization method, with two parallel groups and intention of
      superiority. It was designed to test the hypothesis that a 12-week program of HIIT-LV, yields
      larger beneficial effects on insulin resistance, skeletal muscle composition and endocrine
      function than CAE.

      Although aerobic exercise increases cardio-respiratory capacity, modifies risk factors and
      decreases mortality risk, there is currently controversy and gaps in knowledge over the
      efficacy of more intense and low-volume physical activities on muscle metabolism in patients
      with metabolic disorders.

      The primary outcome will be the insulin resistance, insulin sensitivity and percentage of
      pancreatic β-cell function. The secondary outcomes will be the glycosylated hemoglobin, mass
      and muscle fibre type composition of thigh and plasma levels of musclin and apelin.
      Assessments will be made before and after the 12-week program. Calculations based on
      previously results (difference mean 10% and SD 15%) suggest that a total number of 60
      patients randomized 1:1 (30 in each group) to the two intervention groups is sufficient to
      detect larger beneficial effects with HIIT-LV with a p-value of 0.05 (two-sided test) and
      statistical power of 0.80 (primary endpoint is insulin sensitivity).
    

Intervention name(s): HIIT-LV; CAE
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supervised endurance treadmill training as walking/running "uphill", 3 times/week during 12 weeks starting at 85-90% of previously determined maximum oxygen consumption (VO2 max). Warm-up 3 min at 30% of VO2 max, 3 min cool-down. Progression in intensity every 3erd week.; Supervised moderate intensity treadmill training, 3 times/week for 12 weeks starting at 70% of VO2 max. Warm-up 3 min at 30% of VO2 max, 3 min cool-down. Progression in intensity every 3erd week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; Exercise Training; Interval Training; Skeletal Muscle; Risk Factors; Insulin Resistance