Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Development of Structured Exercise Program for T2DM Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03563456
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Nani Cahyani Sudarsono, Indonesia University

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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Glycemic control (HbA1c) [ Time Frame: Change from baseline HbA1c (%) after 12 weeks of exercise ]
    The percentage of glycated hemoglobin

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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.

  10. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. Gender and age as independent factor [ Time Frame: initial/before intervention ]
    Subjects gender and age

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Indonesia
Center for Sports and Exercise Studies, Indonesian Medical and Research Institute, Faculty of Medicine Universitas Indonesia
Jakarta, Jakarta Pusat, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
Layout table for investigator information
Principal Investigator: Nani C Sudarsono, MD Fakultas Kedokteran Universitas Indonesia
  Study Documents (Full-Text)

Documents provided by Nani Cahyani Sudarsono, Indonesia University:

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Nani Cahyani Sudarsono, Vice Head of Center for Sports and Exercise Studies, Indonesian Medical Education and Research Center, Faculty of Medicine, Universitas Indonesia (Indonesia University), Indonesia University
ClinicalTrials.gov Identifier: NCT03563456     History of Changes
Other Study ID Numbers: FKUI 17-05-0554
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD is planned to be shared after the completion of study analysis and publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nani Cahyani Sudarsono, Indonesia University:
structured exercise
glycemic control
Type 2 Diabetes Mellitus
interval training
resistance training
oxydative stress
physical fitness

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases