Development of Structured Exercise Program for T2DM Management
Condition: Type 2 Diabetes Mellitus; High-Intensity Interval Training; Resistance Training; Oxidative Stress; Physical Fitness
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study started by the process of designing a structured exercise that will manage the T2DM
      with regards to the effectiveness in glycemic control, the benefit for physical fitness, and
      safe. Subjects consist of 18 - 65 years old T2DM patients are allocated into 2 groups; EXP
      group and KTR group. The EXP group follow the protocol of 12-week structured exercise,
      combination of 3 times per week high intensity interval training with 2 times per week
      resistance exercises. The pre- and post- measure are physical fitness consists of VO2max,
      grip strength, sit and reach, push ups, back extension, BMI and body fat percentage; HbA1c;
      plasma MDA and SOD. The KTR group follow the once a week continuous exercise program. The
      structured exercise is hypothesized to lower HbA1c, lower plasma MDA, increase SOD.
    

Detailed description: 
      A structured exercise program is developed incorporating cardiorespiratory and resistance
      exercise. The cardio-respiratory exercise is interval training (High Intensity Interval
      Training/HIIT), combination of one-minute High Intensity Exercise (HIE) and four-minute Low
      Intensity Exercise aiming for six cycles per exercise session at the end of the program. The
      resistance exercise consist of nine exercises, covers knee extension (leg raise), shoulder
      press, chair squat, back row, chest press, lateral pull down, hamstring curl, back up, and
      crunches. The program is to enable subjects to do all the exercises without any major
      complains, therefore the load is increased gradually. At start, the first two weeks consists
      of 20-minute continuous cardiorespiratory exercise at 60-70% HR max on treadmill and nine
      resistance exercise using no weight or minimal external weight. From the third week, the
      interval training will begin with four cycles of one-minute HIE at 90% HRmax followed by
      four-minute LIE at 70% HRmax. The resistance exercises are then beginning with one set of
      light eight-repetition for each exercise. The training load of interval training will
      increase at the seventh week to reach the target of HIE at 92% HRmax followed by four-minute
      LIE at 75% HRmax. The resistance exercises progress with one set of 10-repetition of light
      resistance at week 3-6, then two sets of 10-repetition of medium to heavy resistance.

      The subjects are recruited from the diabetes registry at primary care clinics near the
      exercise facility. The patients are contacted and going through screening examinations such
      as physical examination including Blood Pressure and ECG recording; fundus photography; blood
      examination for HbA1c, Hb, and and urine examination for albumin and creatinine measurement.

      The eligible subjects will the follow the initial examination to determine the level of
      physical fitness (cardiorespiratory fitness, muscle strength, muscle endurance, flexibility,
      and body composition measures); plasma MDA and SOD; HbA1c; and Quality of Life (QoL) measure.

      Two groups will be formed, the experiment (EXP), and control (KTR) groups using block of four
      random allocation. Twelve-week structured exercise program is conducted under physician
      supervision. For each exercise session, the eligibility criteria is resting HR not more than
      100/min; resting BP not more than 180/100 mmHg, and glucose level not more than 300 mg/dL.
      The subjects are also advised to report any adverse feelings or if they perceived untolerable
      exertion.

      The EXP group program consists of three-session per week of cardiorespiratory interval
      training and two-session per week of resistance exercise. The KTR group program consists of
      once per week of continuous cardiorespiratory exercise. The program for the KTR group is also
      a progression of duration and intensity from 20-minute 60-70% HRmax to 30-minute 75-80% HRmax
      at the last six week of the program.

      During the 12-week program, the subjects are asked to maintain their medication, diet, and
      physical activities. All of the subjects carry a pedometer during the 12-week program, and
      the diet and physical activities are to be recorded at the end of each 4-week time using
      three-day food record and Bouchard's three-day physical activity record.

      At the end of the program, the examination to determine the level of physical fitness
      (cardiorespiratory fitness, muscle strength, muscle endurance, flexibility, and body
      composition measures); plasma MDA and SOD; HbA1c; and Quality of Life (QoL) measure are
      repeated. The EXP-KTR group mean difference and the difference of increase/decrease between
      group are measured to determine the effect of the program.

      To ensure about the effect of the program, the influence of nutrition intake and physical
      activity to the primary results will be analyzed. So as the influence of other independent
      factors such as gender, age, and the previous history of length of diagnosed as T2DM and
      regular physical activity.
    

Intervention name(s): structured combined exercise; cardiorespiratory exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A structured designed exercise consists of three times per week interval cardiorespiratory training of High Intensity Interval Training incorporates cycles of 1:4 interval and two times per week Resistance Exercise consists of nine-movement.; Once per week continuous cardiorespiratory training of moderate intensity
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: structured exercise; glycemic control; Type 2 Diabetes Mellitus; interval training; resistance training; oxydative stress; physical fitness