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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Muhamad Faiz Alias, BPT, MSc (sport science)
- 电话号码：+60355442912
- 邮箱：faiz.fisio@gmail.com
学习地点
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Selangor
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Kuala Selangor、Selangor、马来西亚、42300
- Hospital Sultan Al-Abdullah (HASA)
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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有源比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Glycated Haemoglobin (HbA1c)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Body Composition
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 600-RMC/MOHE HICoE CARE-I 5/3
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IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
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