Development of Structured Exercise Program for T2DM Management
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|ClinicalTrials.gov Identifier: NCT03563456|
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus High-Intensity Interval Training Resistance Training Oxidative Stress Physical Fitness||Behavioral: structured combined exercise Behavioral: cardiorespiratory exercise||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
The assessors for blood measure are not aware of the group of experiment, since the blood samples will not carry any descriptions of the group.
The assessors for physical fitness are not aware of the group of experiment, since the medical record is not provided to the assessors.
|Official Title:||Development of Structured Exercise Program Based on Patient Condition for Type 2 Diabetes Mellitus Management|
|Actual Study Start Date :||June 5, 2017|
|Actual Primary Completion Date :||January 15, 2018|
|Actual Study Completion Date :||April 30, 2018|
Experimental: EXPERIMENT (EXP)
Subjects conduct the structured combined exercise in form of combination of High Intensity Interval Training and Resistance Training
Behavioral: structured combined exercise
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.
Active Comparator: CONTROL (KTR)
Subjects conduct structured exercise of cardiorespiratory training in form of lower-volume continuous cardiorespiratory exercise.
Behavioral: cardiorespiratory exercise
Once per week continuous cardiorespiratory training of moderate intensity
- Glycemic control (HbA1c) [ Time Frame: Change from baseline HbA1c (%) after 12 weeks of exercise ]The percentage of glycated hemoglobin
- Maximum oxygen uptake (VO2max) [ Time Frame: Change from baseline VO2max (ml/kg.min) after 12 weeks of exercise ]Maximum volume of oxygen uptake per kilogram of body weight per minute (ml/kg.min) as part of physical fitness measure.
- Grip strength [ Time Frame: Change from baseline Grip strength (kg) after 12 weeks of exercise ]A measure of isometric hand strength shown by maximum force applied by the hand to squeeze a part of grip dynamometer (kilogram) as part of physical fitness measure.
- Push-up [ Time Frame: Change from baseline Push-up (number) after 12 weeks of exercise ]A measure of muscular endurance of the chest, shoulders and arms, shown by the number of as many consecutive push-ups performed without time limit as part of physical fitness measure.
- Sit and reach [ Time Frame: Change from baseline Sit and reach (cm) after 12 weeks of exercise ]A measure of general flexibility shown by hamstring and lower back flexibility, as a result of maximum flexion of the upper body with legs fully extended, arms evenly stretched with palms down and hands together reaching forward as far as possible (centimeter) as part of physical fitness measure.
- Back extension [ Time Frame: Change from baseline Back extension (sec) after 12 weeks of exercise ]A measure of the isometric endurance (time in seconds) of the trunk extensor muscles, as a result of maintaining horizontal position while lie face down (seconds) as part of physical fitness measure.
- BMI (Body Mass Index) [ Time Frame: Change from baseline BMI (kg/m^2) after 12 weeks of exercise ]A measure of body composition based on weight (kilogram) in relation to height (meter), combined to report in kg/m^2 as part of physical fitness measure
- Fat percentage [ Time Frame: Change from baseline Fat percentage (kg/m^2) after 12 weeks of exercise ]A measure of fat percentage using bio-electrical impedance analysis to measure body fat (percent) as part of physical fitness measure.
- Free radicals [ Time Frame: Change from baseline MDA (nmol/mL) after 12 weeks of exercise ]The measure of production of the free radicals, as a result of measuring concentration (nmol/mL) of plasma malondialdehyde (MDA) as part of oxydative stress measure.
- Antioxydants [ Time Frame: Change from baseline SOD (U/mL) after 12 weeks of exercise ]The measure of antioxydants activities, as a result of measuring plasma superoxide dismutase (SOD) activity (U/mL) as part of oxydative stress measure.
- Quality of Life [ Time Frame: Before and after 12-week intervention ]A measure of health-related quality of life using visual analog scale (VAS) part of EuroQol Group EQ-5D questionnaire, ranging of scale 0 - 100 (0 is the worst health state and 100 is the best health state that the subject can imagine)
- Physical activity during intervention [ Time Frame: 4th, 8th, and 12th week of intervention ]The amount of energy expenditure during intervention, conducted by records of steps stated by each subject's pedometer and in accordance with Bouchard's three-day physical activity record
- Nutritional intake during intervention [ Time Frame: 4th, 8th, and 12th week of intervention ]The amount of energy intake during intervention, conducted with three-day food intake record
- Gender and age as independent factor [ Time Frame: initial/before intervention ]Subjects gender and age
- Personal history as independent factor [ Time Frame: initial/before intervention ]Subjects' history that revealed the length of time of diagnosis, and history of previous regular exercise
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563456
|Center for Sports and Exercise Studies, Indonesian Medical and Research Institute, Faculty of Medicine Universitas Indonesia|
|Jakarta, Jakarta Pusat, Indonesia, 10430|
|Principal Investigator:||Nani C Sudarsono, MD||Fakultas Kedokteran Universitas Indonesia|