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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Muhamad Faiz Alias, BPT, MSc (sport science)
- Telefonní číslo: +60355442912
- E-mail: faiz.fisio@gmail.com
Studijní místa
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Selangor
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Kuala Selangor, Selangor, Malajsie, 42300
- Hospital Sultan Al-Abdullah (HASA)
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Glycated Haemoglobin (HbA1c)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Body Composition
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Onemocnění endokrinního systému
- Nemoci nervového systému
- Neuromuskulární projevy
- Patologické stavy, anatomické
- Metabolické choroby
- Poruchy metabolismu glukózy
- Diabetes Mellitus
- Hyperinzulinismus
- Svalová atrofie
- Atrofie
- Patologické stavy, příznaky a symptomy
- Nutriční a metabolické nemoci
- Příznaky a symptomy
- Diabetes mellitus, typ 2
- Rezistence na inzulín
- Sarkopenie
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