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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-STORM Training plus Usual Care | Experimental | 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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| Usual Care | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-STORM Resistance Training Programme | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Haemoglobin (HbA1c) | 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). | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | 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. | Baseline to 12 weeks |
| Functional Exercise Capacity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhamad Faiz Alias, BPT, MSc (sport science) | Contact | +60355442912 | faiz.fisio@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sultan Al-Abdullah (HASA) | Kuala Selangor | Selangor | 42300 | Malaysia |
Individual participant data that underlie the results reported in the published article will be made available after de-identification, including text, tables, figures, and appendices.
Beginning 6 months after publication, for a period of 5 years.
Data will be shared with researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.
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Two-arm parallel randomised controlled trial. Participants are randomly allocated 1:1 to either the D-STORM resistance training programme plus usual care, or usual care alone, for 12 weeks. Randomisation is performed using a computer-generated sequence with allocation concealment via sequentially numbered sealed opaque envelopes.
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Blinding is not applicable in this study. Due to the nature of the exercise intervention, participants and the treating physiotherapist can readily distinguish group allocation. The study is therefore conducted as an open-label trial.
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| usual care | Other | 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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Assessed using the Incremental Shuttle Walk Test (ISWT), measuring the maximum distance walked under a progressively increasing pace protocol. |
| Baseline to 12 weeks |
| Blood Pressure | Systolic and diastolic blood pressure (mmHg) measured at Visits 1, 3, 5, 7, and 9. | Baseline to 12 weeks |
| Resting Heart Rate | Resting heart rate (bpm) measured at Visits 1, 3, 5, 7, and 9. | Baseline to 12 weeks |
| Health-Related Quality of Life | Assessed using the SF-36 questionnaire at baseline and post-intervention (12 weeks). | Baseline to 12 weeks |
| Exercise Self-Efficacy | Self-reported exercise self-efficacy measured by validated questionnaire at baseline and post-intervention (12 weeks). | Baseline to 12 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D055948 | Sarcopenia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006946 | Hyperinsulinism |
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