Development of Structured Exercise Program for T2DM Management

NCT03563456 | Completed DMC

• 1 other identifier: FKUI 17-05-0554
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (10)

• Glycemic control (HbA1c)

  The percentage of glycated hemoglobin

  Change from baseline HbA1c (%) after 12 weeks of exercise

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Quality of Life

  Before and after 12-week intervention

• Physical activity during intervention

  4th, 8th, and 12th week of intervention

• Nutritional intake during intervention

  4th, 8th, and 12th week of intervention

• Gender and age as independent factor

  initial/before intervention

• Personal history as independent factor

  initial/before intervention

Study Arms (2)

EXPERIMENT (EXP)

EXPERIMENTAL

Subjects conduct the structured combined exercise in form of combination of High Intensity Interval Training and Resistance Training

Behavioral: structured combined exercise

CONTROL (KTR)

ACTIVE COMPARATOR

Subjects conduct structured exercise of cardiorespiratory training in form of lower-volume continuous cardiorespiratory exercise.

Behavioral: cardiorespiratory exercise

Interventions

structured combined exercise BEHAVIORAL

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.

EXPERIMENT (EXP)

cardiorespiratory exercise BEHAVIORAL

Once per week continuous cardiorespiratory training of moderate intensity

CONTROL (KTR)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Center for Sports and Exercise Studies, Indonesian Medical and Research Institute, Faculty of Medicine Universitas Indonesia

Jakarta, Jakarta Pusat, 10430, Indonesia

Location

Related Publications (4)

• 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.

  PMID: 23463651 BACKGROUND

• 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.

  PMID: 25323267 RESULT

• 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.

  PMID: 24102912 RESULT

• 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.

  PMID: 20336198 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nani C Sudarsono, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Head of Center for Sports and Exercise Studies, Indonesian Medical Education and Research Center, Faculty of Medicine, Universitas Indonesia (Indonesia University)

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 20, 2018
• Study Start: June 5, 2017
• Primary Completion: January 15, 2018
• Study Completion: April 30, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available starting 6 months after publication
• Access Criteria: Academics will be able to access information regarding unnamed subject characteristics and intervention detail by sending request to principal investigator. A clearly stated purpose of access will be reviewed.

Locations

ID (1)