Clinical trial NCT03563456: Development of Structured Exercise Program for T2DM Management
Official title: Development of Structured Exercise Program Based on Patient Condition for Type 2 Diabetes Mellitus Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
High-Intensity Interval Training
Resistance Training
Oxidative Stress
Physical Fitness
Keywords: structured exercise
glycemic control
Type 2 Diabetes Mellitus
interval training
resistance training
oxydative stress
physical fitness
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic control (HbA1c)
timeFrame: Change from baseline HbA1c (%) after 12 weeks of exercise
measure: Maximum oxygen uptake (VO2max)
timeFrame: Change from baseline VO2max (ml/kg.min) after 12 weeks of exercise
measure: Grip strength
timeFrame: Change from baseline Grip strength (kg) after 12 weeks of exercise
measure: Push-up
timeFrame: Change from baseline Push-up (number) after 12 weeks of exercise
measure: Sit and reach
timeFrame: Change from baseline Sit and reach (cm) after 12 weeks of exercise
measure: Back extension
timeFrame: Change from baseline Back extension (sec) after 12 weeks of exercise
measure: BMI (Body Mass Index)
timeFrame: Change from baseline BMI (kg/m^2) after 12 weeks of exercise
measure: Fat percentage
timeFrame: Change from baseline Fat percentage (kg/m^2) after 12 weeks of exercise
measure: Free radicals
timeFrame: Change from baseline MDA (nmol/mL) after 12 weeks of exercise
measure: Antioxydants
timeFrame: Change from baseline SOD (U/mL) after 12 weeks of exercise
Secondary outcomes:
measure: Quality of Life
timeFrame: Before and after 12-week intervention
measure: Physical activity during intervention
timeFrame: 4th, 8th, and 12th week of intervention
measure: Nutritional intake during intervention
timeFrame: 4th, 8th, and 12th week of intervention
measure: Gender and age as independent factor
timeFrame: initial/before intervention
measure: Personal history as independent factor
timeFrame: initial/before intervention
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Center for Sports and Exercise Studies, Indonesian Medical and Research Institute, Faculty of Medicine Universitas Indonesia
state: Jakarta Pusat
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Nani C Sudarsono, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Hollekim-Strand SM, Bjorgaas MR, Albrektsen G, Tjonna AE, Wisloff 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 Coll Cardiol. 2014 Oct 21;64(16):1758-60. doi: 10.1016/j.jacc.2014.07.971. No abstract available.
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 17.
citation: 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.