The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM) (D-STORM)
The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM): Rationale and Study Protocol for a Randomized Controlled Trial
Type 2 diabetes is associated with progressive loss of muscle mass, which worsens blood sugar control and increases the risk of heart disease and disability. Resistance training (weight training) has been shown to build muscle and improve blood sugar levels, but most existing programmes use high intensities that are difficult for older or inactive people with diabetes to sustain.
This study tests a new resistance training programme called D-STORM (Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population), which uses a lower, more manageable training load designed to be safe, tolerable, and effective for adults with Type 2 diabetes who are not on insulin.
Participants will be randomly assigned to either twice-weekly D-STORM training plus their usual diabetes care, or usual care alone, for 12 weeks. The main outcome measured is change in HbA1c (a blood test reflecting average blood sugar over 3 months). Body composition, walking capacity, blood pressure, heart rate, and quality of life will also be measured.
연구 개요
상태
상세 설명
The D-STORM trial is a 2-arm parallel randomised controlled trial conducted at Hospital Sultan Al-Abdullah (HASA), Puncak Alam, Selangor, Malaysia. Adults aged 18 to 65 years with Type 2 diabetes mellitus (HbA1c 6.5% to 13.0%) who are not on insulin therapy will be recruited and randomly allocated 1:1 to the D-STORM intervention arm or the usual care arm.
The D-STORM programme consists of 6 compound resistance exercises performed twice weekly on non-consecutive days for 12 weeks, at 60-80% of one-repetition maximum (1RM), 2 working sets per exercise, using the double progression model with sets terminated at 1-3 repetitions in reserve (RIR).
The primary outcome is between-group difference in HbA1c (%) from baseline to 12 weeks, with a minimum clinically important difference of 1.0% absolute reduction. Secondary outcomes include body composition (bioelectrical impedance analysis; InBody 270), functional exercise capacity (Incremental Shuttle Walk Test), blood pressure, resting heart rate, and health-related quality of life (SF-36). Sample size: 124 participants (62 per arm), accounting for 10% dropout.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Muhamad Faiz Alias, BPT, MSc (sport science)
- 전화번호: +60355442912
- 이메일: faiz.fisio@gmail.com
연구 장소
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Selangor
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Kuala Selangor, Selangor, 말레이시아, 42300
- Hospital Sultan Al-Abdullah (HASA)
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Aged 18 to 65 years
- Confirmed diagnosis of Type 2 Diabetes Mellitus
- HbA1c between 6.5% and 13.0%
- Not currently on insulin therapy
- Has a primary care provider
Exclusion Criteria:
- Age below 18 or above 65 years
- Blood pressure 160/100 mmHg or higher at screening
- HbA1c below 6.5% or above 13.0%
- Currently on insulin therapy
- Pregnant or planning to become pregnant within the next 6 months
- Serious medical conditions that would prevent safe participation in an exercise programme
- Any physical or functional limitation that would prevent participation in resistance training
- Underlying conditions that would not allow safe participation in the exercise intervention
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: D-STORM Training plus Usual Care
Participants perform the D-STORM resistance training programme twice weekly on non-consecutive days for 12 weeks, comprising 6 compound exercises at 60-80% 1RM, 2 working sets per exercise, terminated at 1-3 repetitions in reserve, using the double progression model.
Participants also continue their usual diabetes care throughout.
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Twice-weekly progressive resistance training comprising 6 compound exercises (upper body pull, upper body push, lower body push, lower body pull) at 60-80% 1RM, 2 working sets per exercise per session (minimum 4 sets per muscle group per week), 8-12 repetitions per set, terminated at 1-3 repetitions in reserve.
Load is progressively increased using the double progression model.
Total intervention duration is 12 weeks.
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활성 비교기: Usual Care
Participants receive standard diabetes care in accordance with the Malaysian Clinical Practice Guidelines for Type 2 Diabetes Management (6th Edition), including general physical activity recommendations of at least 150 minutes of moderate-intensity aerobic activity per week.
No structured or supervised exercise is provided.
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Participants receive standard diabetes care in accordance with the Malaysian Clinical Practice Guidelines for Type 2 Diabetes Management (6th Edition), including general physical activity recommendations of at least 150 minutes of moderate-intensity aerobic activity per week distributed over at least 3 days, with resistance exercise on a minimum of 2 non-consecutive days per week.
No structured, supervised, or progressive training is provided.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Glycated Haemoglobin (HbA1c)
기간: Baseline to 12 weeks
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Between-group difference in HbA1c (%) from baseline to 12 weeks.
The minimum clinically important difference is defined as a reduction of ≥1.0% absolute HbA1c.
Measured by standardised laboratory assay at baseline (Visit 1) and post-intervention (Visit 7).
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Baseline to 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body Composition
기간: Baseline to 12 weeks
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Segmental body composition including skeletal muscle mass, fat mass, fat-free mass, and body fat percentage measured by bioelectrical impedance analysis (InBody 270) under standardised conditions.
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Baseline to 12 weeks
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Functional Exercise Capacity
기간: Baseline to 12 weeks
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Assessed using the Incremental Shuttle Walk Test (ISWT), measuring the maximum distance walked under a progressively increasing pace protocol.
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Baseline to 12 weeks
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Blood Pressure
기간: Baseline to 12 weeks
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Systolic and diastolic blood pressure (mmHg) measured at Visits 1, 3, 5, 7, and 9.
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Baseline to 12 weeks
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Resting Heart Rate
기간: Baseline to 12 weeks
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Resting heart rate (bpm) measured at Visits 1, 3, 5, 7, and 9.
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Baseline to 12 weeks
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Health-Related Quality of Life
기간: Baseline to 12 weeks
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Assessed using the SF-36 questionnaire at baseline and post-intervention (12 weeks).
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Baseline to 12 weeks
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Exercise Self-Efficacy
기간: Baseline to 12 weeks
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Self-reported exercise self-efficacy measured by validated questionnaire at baseline and post-intervention (12 weeks).
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Baseline to 12 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 600-RMC/MOHE HICoE CARE-I 5/3
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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