Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks (Ulcer)
11 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
80
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
wound healing volume (cm3))
Prazo: at base line and 12 weeks
|
saline injection
|
at base line and 12 weeks
|
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wound healing (surface area(cm2)
Prazo: at base line and 12 weeks
|
using Image J software
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at base line and 12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Venous Filling Index (VFI) (mL/sec)
Prazo: 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) (%).
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
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Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
1 de fevereiro de 2027
Conclusão do estudo (Estimado)
5 de fevereiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
4 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de agosto de 2026
Primeira postagem (Real)
13 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00014233-94
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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