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Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks (Ulcer)

2026年11月8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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Amman、约旦、11118
        • 招聘中
        • Zaytoonah University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的: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

有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
wound healing volume (cm3))
大体时间:at base line and 12 weeks

saline injection

at base line and 12 weeks
wound healing (surface area(cm2)
大体时间:at base line and 12 weeks

using Image J software

at base line and 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Venous Filling Index (VFI) (mL/sec)
大体时间: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.

at baseline and 12 weeks
Ejection Fraction (EF) (%).
大体时间: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.

at base line and 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年1月5日

研究注册日期

首次提交

2026年8月4日

首先提交符合 QC 标准的

2026年8月11日

首次发布 (实际的)

2026年8月13日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月8日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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