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Development of Structured Exercise Program for T2DM Management

2018년 6월 8일 업데이트: Nani Cahyani Sudarsono, Indonesia University

Development of Structured Exercise Program Based on Patient Condition for Type 2 Diabetes Mellitus Management

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

42

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Jakarta Pusat
      • Jakarta, Jakarta Pusat, 인도네시아, 10430
        • Center for Sports and Exercise Studies, Indonesian Medical and Research Institute, Faculty of Medicine Universitas Indonesia

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: EXPERIMENT (EXP)
Subjects conduct the structured combined exercise in form of combination of High Intensity Interval Training and Resistance Training
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.
활성 비교기: CONTROL (KTR)
Subjects conduct structured exercise of cardiorespiratory training in form of lower-volume continuous cardiorespiratory exercise.
Once per week continuous cardiorespiratory training of moderate intensity

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Glycemic control (HbA1c)
기간: Change from baseline HbA1c (%) after 12 weeks of exercise
The percentage of glycated hemoglobin
Change from baseline HbA1c (%) after 12 weeks of exercise
Maximum oxygen uptake (VO2max)
기간: 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.
Change from baseline VO2max (ml/kg.min) after 12 weeks of exercise
Grip strength
기간: 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.
Change from baseline Grip strength (kg) after 12 weeks of exercise
Push-up
기간: 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.
Change from baseline Push-up (number) after 12 weeks of exercise
Sit and reach
기간: 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.
Change from baseline Sit and reach (cm) after 12 weeks of exercise
Back extension
기간: 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.
Change from baseline Back extension (sec) after 12 weeks of exercise
BMI (Body Mass Index)
기간: 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
Change from baseline BMI (kg/m^2) after 12 weeks of exercise
Fat percentage
기간: 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.
Change from baseline Fat percentage (kg/m^2) after 12 weeks of exercise
Free radicals
기간: 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.
Change from baseline MDA (nmol/mL) after 12 weeks of exercise
Antioxydants
기간: 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.
Change from baseline SOD (U/mL) after 12 weeks of exercise

2차 결과 측정

결과 측정
측정값 설명
기간
Quality of Life
기간: 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)
Before and after 12-week intervention
Physical activity during intervention
기간: 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
4th, 8th, and 12th week of intervention
Nutritional intake during intervention
기간: 4th, 8th, and 12th week of intervention
The amount of energy intake during intervention, conducted with three-day food intake record
4th, 8th, and 12th week of intervention
Gender and age as independent factor
기간: initial/before intervention
Subjects gender and age
initial/before intervention
Personal history as independent factor
기간: initial/before intervention
Subjects' history that revealed the length of time of diagnosis, and history of previous regular exercise
initial/before intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Nani C Sudarsono, MD, Fakultas Kedokteran Universitas Indonesia

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 6월 5일

기본 완료 (실제)

2018년 1월 15일

연구 완료 (실제)

2018년 4월 30일

연구 등록 날짜

최초 제출

2018년 5월 24일

QC 기준을 충족하는 최초 제출

2018년 6월 8일

처음 게시됨 (실제)

2018년 6월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 6월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 6월 8일

마지막으로 확인됨

2018년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

IPD is planned to be shared after the completion of study analysis and publication

IPD 공유 기간

Data will become available starting 6 months after publication

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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