Type 2 Diabetes Mellitus Clinical Trial
Official title:
Development of Structured Exercise Program Based on Patient Condition for Type 2 Diabetes Mellitus Management
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.
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.
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