The Effects of Aerobic Exercises on Exercise Capacity in Type-2 Diabetes Mellitus
Condition: Type-2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes, beyond glycemic control, is a complex chronic disease that requires continuous
      medical care with multifactorial risk reduction strategies. It is necessary to reduce the
      likelihood of complications and additional problems that may develop in the long term. For
      this reason, guiding the patient to manage the disease process, equipping and supporting the
      patient with the necessary information is critical to prevent acute problems.

      Exercise is the primary treatment method for diabetes patients. Exercise; It is the main
      treatment method used to increase aerobic capacity and improve respiratory capacity due to
      the positive effect it has on the body's structure and systems.
    

Detailed description: 
      Firstly, patients were examined by the specialist doctor. If patients appropriate for this
      study according to inclusion and exclusion criteria, they were consulted to Cardiologist for
      stress ECG test and acceptation report to high or moderate-intensity aerobic training.

      After baseline testing (including aerobic capacity and lung capacity), appropriate patients
      were randomized to HIIT or MICT groups involving sixteenth sessions of exercise performed
      over 6 weeks The HIIT exercise protocol involved 28 minutes of treadmill efforts. The
      patients performed the interval training for 4 minutes with 80%HRmax and active recovery
      period maintained for 3 minutes with 60% HRmax on the treadmill. This protocol repeated 4
      times in a session. The MICT exercise protocol performed with %60 HRmax for 28 minutes
      similarly HIIT group. A 10-min warm-up and 10-min cool-down period were included for all
      groups. All groups reassessed after the 6. weeks (end of the exercise program) and 12. weeks
      (follow-up period).

      Aerobic capacity assessed with an Incremental Shuttle Walk Test (ISWT). Clinicians need to 10
      m field, audiotape recorder, chronometer, and two markers. This test consists of 12 levels,
      every level maintains1 minute and the walking speed is increased after every1 minute
      intervals. If the patients wanted to stop because of fell breathless or can't reach the end
      of the 10 m line' last 0.5 m in the time allowed, the test was stopped.Estimated VO2max was
      calculated a formula as "Estimated VO2max (ml/dk/kg)= 4.19 + (0.025 x ISWT distance)".

      The patient's pulmonary functions assessed with a digital spirometer (Pony FX, COSMED Inc.,
      Italy). Spirometer device measures FVC, FEV1, FEV1/FVC and PEF values. During the test, upper
      extremity was straight and patients sitting straight position on the chair with their
      vertical feet on the floor. The measurements were performed 3 times and the best score
      recorded with mean and standard deviation.

      The measurements were coded into the analysis program and checked by a second researcher.

      Post-hoc power analysis was done using aerobic capacity data, which is the main output of our
      study. The power of the study was determined as 94%.

      Patients who had missing data, patients who did not complete the 6-weeks exercise program and
      12. weeks follow-up period were excluded from the analysis. All analyses were performed using
      the Statistical Package for the Social Sciences (SPSS) version 22. 0 for Windows. Data are
      expressed as mean ± standard deviation. The one-sample Kolmogorov-Smirnov test was performed
      to assess the distribution of data. Due to their distribution, numerical variables in
      different subjects were compared with the t-test or Mann-Whitney U test. Comparison of
      variables before and after the exercise program were compared by the paired t-test
      (parametric variable) or Wilcoxon test (non-parametric variable). Probability values were
      two-tailed, and a p-value of less than 0.05 was considered as significant.
    

Intervention name(s): Aerobic Exercise
Intervention type(s): Procedure
Intervention description(s): Exercise loading is determined by increasing the heart rate. This loading calculated by Karvonen formulas (maximum %80 of Heart Rate)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: High-Intensity Interval Training Group (HIIT): The HIIT exercise protocol involved 28 minutes of treadmill efforts. The patients performed the interval training for 4 minutes with 80%HRmax and active recovery period maintained for 3 minutes with 60% HRmax on the treadmill with Karvonen formula.This protocol repeated 4 times in a session for 6 weeks.
Moderate Intensity Continous Training (MICT): The MICT exercise protocol performed with %60 HRmax for 28 minutes for 6 weeks.
Masking: None (Open Label)
Primary purpose: Treatment