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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Muhamad Faiz Alias, BPT, MSc (sport science)
- 電話番号：+60355442912
- メール：faiz.fisio@gmail.com
研究場所
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Selangor
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Kuala Selangor、Selangor、マレーシア、42300
- Hospital Sultan Al-Abdullah (HASA)
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Glycated Haemoglobin (HbA1c)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body Composition
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 600-RMC/MOHE HICoE CARE-I 5/3
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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