Type 2 Diabetes Mellitus Clinical Trial
Official title:
Development of Structured Exercise Program Based on Patient Condition for Type 2 Diabetes Mellitus Management
Verified date | June 2018 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | April 30, 2018 |
Est. primary completion date | January 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Registered as type 2 Diabetes Mellitus for more than 6 months in primary care clinics - Medication: oral anti hyperglycemic agent - Glucose controlled shows by HbA1c not more than 10.5% - Able to move around without assisstant - Commit to do three times per week of exercise at the training center for 12-week - Voluntarily sign an informed consent document Exclusion Criteria: - Already developing type 2 Diabetes Mellitus complications, such as severe microalbuminuria, severe non proliferative diabetes retinopathy - Have medical condition that prevent oneself from doing exercise, such as history of chest pain/miocardial infarction, exercise-induced asthma, scoliosis, severe arthritis |
Country | Name | City | State |
---|---|---|---|
Indonesia | Center for Sports and Exercise Studies, Indonesian Medical and Research Institute, Faculty of Medicine Universitas Indonesia | Jakarta | Jakarta Pusat |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Aylin K, Arzu D, Sabri S, Handan TE, Ridvan A. The effect of combined resistance and home-based walking exercise in type 2 diabetes patients. Int J Diabetes Dev Ctries. 2009 Oct;29(4):159-65. doi: 10.4103/0973-3930.57347. — View Citation
Hollekim-Strand SM, Bjørgaas MR, Albrektsen G, Tjønna AE, Wisløff U, Ingul CB. High-intensity interval exercise effectively improves cardiac function in patients with type 2 diabetes mellitus and diastolic dysfunction: a randomized controlled trial. J Am — View Citation
Mitranun W, Deerochanawong C, Tanaka H, Suksom D. Continuous vs interval training on glycemic control and macro- and microvascular reactivity in type 2 diabetic patients. Scand J Med Sci Sports. 2014 Apr;24(2):e69-76. doi: 10.1111/sms.12112. Epub 2013 Sep — View Citation
Sparks LM, Johannsen NM, Church TS, Earnest CP, Moonen-Kornips E, Moro C, Hesselink MK, Smith SR, Schrauwen P. Nine months of combined training improves ex vivo skeletal muscle metabolism in individuals with type 2 diabetes. J Clin Endocrinol Metab. 2013 Apr;98(4):1694-702. doi: 10.1210/jc.2012-3874. Epub 2013 Mar 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glycemic control (HbA1c) | The percentage of glycated hemoglobin | Change from baseline HbA1c (%) after 12 weeks of exercise | |
Primary | Maximum oxygen uptake (VO2max) | Maximum volume of oxygen uptake per kilogram of body weight per minute (ml/kg.min) as part of physical fitness measure. | Change from baseline VO2max (ml/kg.min) after 12 weeks of exercise | |
Primary | Grip strength | 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. | Change from baseline Grip strength (kg) after 12 weeks of exercise | |
Primary | Push-up | 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. | Change from baseline Push-up (number) after 12 weeks of exercise | |
Primary | Sit and reach | 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. | Change from baseline Sit and reach (cm) after 12 weeks of exercise | |
Primary | Back extension | 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. | Change from baseline Back extension (sec) after 12 weeks of exercise | |
Primary | BMI (Body Mass Index) | 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 | Change from baseline BMI (kg/m^2) after 12 weeks of exercise | |
Primary | Fat percentage | A measure of fat percentage using bio-electrical impedance analysis to measure body fat (percent) as part of physical fitness measure. | Change from baseline Fat percentage (kg/m^2) after 12 weeks of exercise | |
Primary | Free radicals | 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. | Change from baseline MDA (nmol/mL) after 12 weeks of exercise | |
Primary | Antioxydants | The measure of antioxydants activities, as a result of measuring plasma superoxide dismutase (SOD) activity (U/mL) as part of oxydative stress measure. | Change from baseline SOD (U/mL) after 12 weeks of exercise | |
Secondary | Quality of Life | 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) | Before and after 12-week intervention | |
Secondary | Physical activity during 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 | 4th, 8th, and 12th week of intervention | |
Secondary | Nutritional intake during intervention | The amount of energy intake during intervention, conducted with three-day food intake record | 4th, 8th, and 12th week of intervention | |
Secondary | Gender and age as independent factor | Subjects gender and age | initial/before intervention | |
Secondary | Personal history as independent factor | Subjects' history that revealed the length of time of diagnosis, and history of previous regular exercise | initial/before intervention |
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