The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversiti Teknologi Mara
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 65 years
Confirmed diagnosis of Type 2 Diabetes Mellitus
HbA1c between 6.5% and 13.0%
Not currently on insulin therapy
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
D-STORM Resistance Training Programme
BehavioralTwice-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 interventionParticipants 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.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: D-STORM Training plus Usual CareExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline to 12 weeksSecondary outcomes
1
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.
Time frame
Baseline to 12 weeks2
Functional Exercise Capacity
Assessed using the Incremental Shuttle Walk Test (ISWT), measuring the maximum distance walked under a progressively increasing pace protocol.
Time frame
Baseline to 12 weeks3
Blood Pressure
Systolic and diastolic blood pressure (mmHg) measured at Visits 1, 3, 5, 7, and 9.
Time frame
Baseline to 12 weeks4
Resting Heart Rate
Resting heart rate (bpm) measured at Visits 1, 3, 5, 7, and 9.
Time frame
Baseline to 12 weeksSponsors and contacts
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Source ClinicalTrials.gov
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