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

22. juni 2026 opdateret af: Muhamad Faiz Bin Alias, Universiti Teknologi Mara

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

56

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Muhamad Faiz Alias, BPT, MSc (sport science)
  • Telefonnummer: +60355442912
  • E-mail: faiz.fisio@gmail.com

Studiesteder

  • Malaysia
    • Selangor
      • Kuala Selangor, Selangor, Malaysia, 42300
        • Hospital Sultan Al-Abdullah (HASA)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: D-STORM Resistance Training Programme
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.
Aktiv komparator: 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.
Andet: 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 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Glycated Haemoglobin (HbA1c)
Tidsramme: 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).
Baseline to 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Composition
Tidsramme: 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.
Baseline to 12 weeks
Functional Exercise Capacity
Tidsramme: Baseline to 12 weeks
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
Tidsramme: Baseline to 12 weeks
Systolic and diastolic blood pressure (mmHg) measured at Visits 1, 3, 5, 7, and 9.
Baseline to 12 weeks
Resting Heart Rate
Tidsramme: Baseline to 12 weeks
Resting heart rate (bpm) measured at Visits 1, 3, 5, 7, and 9.
Baseline to 12 weeks
Health-Related Quality of Life
Tidsramme: Baseline to 12 weeks
Assessed using the SF-36 questionnaire at baseline and post-intervention (12 weeks).
Baseline to 12 weeks
Exercise Self-Efficacy
Tidsramme: Baseline to 12 weeks
Self-reported exercise self-efficacy measured by validated questionnaire at baseline and post-intervention (12 weeks).
Baseline to 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universiti Teknologi Mara

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

17. juni 2026

Først indsendt, der opfyldte QC-kriterier

17. juni 2026

Først opslået (Faktiske)

24. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 600-RMC/MOHE HICoE CARE-I 5/3

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Beginning 6 months after publication, for a period of 5 years.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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Kliniske forsøg med Insulin resistens

Kliniske forsøg med D-STORM Resistance Training Programme

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Betingelser

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