Passive Calf Stretching Therapy in Peripheral Artery Disease

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess the effects of passive calf muscle stretching in patients diagnosed with peripheral artery disease (PAD). The main question it aims to answer are: To determine if daily calf muscle stretching at home improves calf muscle and vascular health. To determine if daily calf muscle stretching at home improves walking performance. Participants will use inflatable ankle splints for 30 minutes a day, 5 days a week for 4-weeks on both days and 4-weeks of no stretching.

Detailed Description
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Patients with peripheral artery disease will passively stretch their calf muscles using a stretch device on both feet for 30 minutes a day for 4 weeks. Blood vessel health and size, length and function of the calf muscles and tendons and walking performance will be measured. Joint and foot movements as well as calf muscle oxygen levels will be measured during walking performance tests.

Official Title
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To Stretch, Not Strain: Impact of Passive Stretching on Calf Muscle and Gait Mechanics in PAD

Conditions
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Peripheral Artery Disease, Claudication, Intermittent

Intervention / Treatment
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* Device: Passive calf muscle stretching device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of PAD Stable condition (PAD symptoms) for at least 3 months Age 40-85 Men and women who are not pregnant or nursing Exclusion Criteria: Ischemic leg pain at rest; critical limb ischemia (ulceration or gangrene) Any condition other than PAD that limits the ability to walk Major surgery or lower extremity revascularization surgery in the past 6 months Myocardial infarction within past 6 months or unstable angina Severe lung disease (on supplemental oxygen or frequently use rescue inhalers) Participants with non-compressible vessels (ABI > 1.40) Habitual exercise (30 minutes of continuous activity on 3 or more days per week) Current tobacco smoker or use of nicotine-containing products Pregnant or nursing women History or ankle reconstruction or surgery Recent history (<1 year) of injuries to the ankle, Achilles tendon, or feet History of rheumatoid arthritis or other degenerative joint disease Major medical illness treatment during the prior 12 months Uncontrolled hypertension Uncontrolled diabetes Inability to walk on a treadmill at a slow pace (1.0 mile/hour)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomized to 4-weeks of stretching or no stretching. Following the first 4-week intervention, participants will crossover and perform whichever intervention they did not receive previously.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4-weeks of passive calf stretching for 30 minutes 5 days a week<br>A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle. | Device: Passive calf muscle stretching device<br>* Modified night splints will be used to passive stretch the calf muscle.<br>* Other names: Plantar fasciitis night splints;|
| No Intervention: 4-weeks of no-stretching<br>No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk test distance | Submaximal exercise test used to assess aerobic capacity and endurance | 6-12 minutes | 
| Muscle to tendon ratio | The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound | 45 minutes | 
| Endothelial function | Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelial dysfunction