The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM)

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.

• 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.
• 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.

Primary outcomes

• Glycated Haemoglobin (HbA1c) [Baseline to 12 weeks]: 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).

Secondary outcomes

• Body Composition [Baseline to 12 weeks]: 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.
• Functional Exercise Capacity [Baseline to 12 weeks]: Assessed using the Incremental Shuttle Walk Test (ISWT), measuring the maximum distance walked under a progressively increasing pace protocol.
• Blood Pressure [Baseline to 12 weeks]: Systolic and diastolic blood pressure (mmHg) measured at Visits 1, 3, 5, 7, and 9.
• Resting Heart Rate [Baseline to 12 weeks]: Resting heart rate (bpm) measured at Visits 1, 3, 5, 7, and 9.
• Health-Related Quality of Life [Baseline to 12 weeks]: Assessed using the SF-36 questionnaire at baseline and post-intervention (12 weeks).
• Exercise Self-Efficacy [Baseline to 12 weeks]: Self-reported exercise self-efficacy measured by validated questionnaire at baseline and post-intervention (12 weeks).

Sex: All, ages: 18 Years to 65 Years

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