Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks (Ulcer)
2026年8月11日 更新者：Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d、MTI University
Optimizing Venous Leg Ulcer Healing Via Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
investigates the comparative effectiveness of two interventions aimed at promoting the healing of venous leg ulcers-a common chronic condition characterized by impaired venous return and poor wound healing in the lower extremities.
The research explores whether structured and supervised calf muscle pump activation exercises, delivered with individualized dose-response protocols, can enhance venous return and improve ulcer healing outcomes more effectively than traditional recommendations for unsupervised home walking.
The structured intervention likely involves targeted exercises designed to optimize the activation and function of the calf muscle pump, which is crucial for facilitating blood flow from the legs back to the heart.
In contrast, the unsupervised home walks represent a less controlled, patient-led approach often prescribed in clinical practice.
By comparing these approaches, the study seeks to determine if a more scientific, structured exercise regimen tailored to each patient's response yields superior healing rates, better compliance, and improved patient quality of life.
Ultimately, the findings may inform best practices for physical therapy and rehabilitation strategies in the management of venous leg ulcers, potentially leading to more personalized and effective treatment protocols in clinical and home settings.
調査の概要
詳細な説明
The research aims to determine whether a structured, dose-response regimen of calf muscle pump activation exercises, which are specifically designed and supervised to maximize venous return in the lower limbs, can enhance ulcer healing rates more effectively than the traditional recommendation of unsupervised home walking.
Participants are divided into two groups: one receives guided interventions with tailored exercise frequency, duration, and intensity to systematically activate the calf muscle pump, while the control group is advised to perform regular home walks without supervision or specific guidance.
The study meticulously measures healing outcomes, adherence, vascular function, and patient quality of life to assess the true impact of structured exercise versus informal activity.
By analyzing these variables, the research seeks to provide evidence-based recommendations for optimizing therapeutic strategies in the management of venous leg ulcers, potentially shifting clinical practice toward more prescriptive and individualized physical activity guidelines, and highlighting the importance of targeted exercise science in post-secondary physical education and rehabilitation curricula.
研究の種類
介入
入学 (推定)
80
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria
- Age (ge 20 - 60) years with a confirmed, non-healing VLU (present for \(>6\) weeks).
- Ulcer surface area between \(2 \text{ cm}^2\) and \(20 \text{ cm}^2\).
- Ankle-Brachial Index (ABI) \(\ge 0.8\), ensuring adequate arterial perfusion.
- Able to provide informed consent and comply with follow-up appointments. Exclusion Criteria
- Severe, uncompensated congestive heart failure (NYHA Class III or IV).
- Active local wound infection or systemic osteomyelitis.
- Deep vein thrombosis (DVT) diagnosed within the past 3 months.
- Severe osteoarthritic limitations rendering ankle movement impossible.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ダブル
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：Group A: Dose-Response Structured CMP Activation Strategy
Weeks 1-4 (Activation Phase): Focuses on establishing baseline mobility. Weeks 5-8 (Hypertrophy & Ejection Phase): Focuses on building muscle pump volume. Weeks 9-12 (Power & Hemodynamic Clearance Phase): Focuses on clearing pooled blood under high pressure. |
Progression Protocol (The Dose-Response) Weeks 1-4 (Activation Phase): Focuses on establishing baseline mobility. Ankle ROM Drills: 3 sets of 15 repetitions of passive and active dorsiflexion/plantar flexion stretches utilizing an inelastic stretching strap. Goal: Overcome joint stiffness to reach >10° of passive dorsiflexion. Seated CMP Loading: Seated heel raises with resistive elastic bands (15 repetitions, 4 sets). Weeks 5-8 (Hypertrophy & Ejection Phase): Focuses on building muscle pump volume. Standing Closed-Kinetic Chain Exercises: Standing bodyweight heel raises performed on a step to allow a deep negative heel deficit (eccentric loading). 4 sets of 12 repetitions. Incline Ergometry: 15 minutes of continuous stationary cycling or treadmill walking at a 5% to 8% incline to force a natural heel-strike and powerful toe-off phase. Weeks 9-12 (Power & Hemodynamic Clearance Phase): Focuses on clearing pooled blood under high pressure. Resisted Plantarflexion: Single-leg standing hee |
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アクティブコンパレータ：Group B: Unsupervised Home Walking (Active Control)
Completely independent and self-managed home program
|
Patients were issued a medical-grade wrist-worn pedometer and a matching ankle sensor.
The device display was blinded (blacked out) to prevent active self-biasing or behavioral modification based on step count numbers.
Data was downloaded retroactively by researchers at bi-weekly clinic visits to measure real-world gait speeds, step counts, total active time, and spatial asymmetries without the patient altering their natural routine.
No constraints were placed on gait modifications.
If the patient guards their wound by walking flat-footed or shuffling, the behavior is recorded but not corrected, providing a true representation of unguided real-world walking mechanics.
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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 |
|---|---|---|
|
wound healing volume (cm3))
時間枠：at base line and 12 weeks
|
saline injection
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at base line and 12 weeks
|
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wound healing (surface area(cm2)
時間枠：at base line and 12 weeks
|
using Image J software
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at base line and 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 |
|---|---|---|
|
Venous Filling Index (VFI) (mL/sec)
時間枠：at baseline and 12 weeks
|
The Venous Filling Index (VFI) is a quantitative measurement used to assess the severity of venous reflux in patients with venous leg ulcers.
It is determined using air plethysmography, which tracks changes in leg volume during and after a series of standardized calf muscle contractions.
VFI is calculated as the rate at which blood refills the veins after each contraction, expressed in milliliters per second (mL/sec).
A higher VFI indicates more rapid venous refilling, reflecting greater venous insufficiency and reflux.
Monitoring VFI allows clinicians to objectively compare the effectiveness of interventions, such as structured calf muscle pump activation strategies versus unsupervised home walks, in improving venous return and supporting ulcer healing.
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at baseline and 12 weeks
|
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Ejection Fraction (EF) (%).
時間枠：at base line and 12 weeks
|
To measure Ejection Fraction (EF) as an indicator of calf muscle pump efficacy during a single contraction, use duplex ultrasound or air plethysmography to assess venous volume changes in the lower leg.
First, record the baseline venous volume with the patient in a relaxed, supine position.
Then, instruct the patient to perform a single, deliberate calf muscle contraction (such as plantarflexion).
Immediately measure the post-contraction venous volume.
EF is calculated as the percentage of blood ejected from the veins during the contraction: EF (%) = [(baseline volume - post-contraction volume) / baseline volume] × 100.
This value quantifies how effectively the calf muscle pump expels venous blood with each contraction.
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at base line and 12 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2027年2月1日
研究の完了 (推定)
2027年2月5日
試験登録日
最初に提出
2026年8月4日
QC基準を満たした最初の提出物
2026年8月11日
最初の投稿 (実際)
2026年8月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月13日
QC基準を満たした最後の更新が送信されました
2026年8月11日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。