Passive Calf Stretching Therapy in Peripheral Artery Disease

The Pennsylvania State University (PENNSTATE)

Status: Enrolling

Conditions: Claudication, Intermittent; Peripheral Artery Disease

Treatments: Device: Passive calf muscle stretching device

Study type: Interventional

Funder types: Other

Identifiers

NCT06041880

00022960

Details and patient eligibility

About

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:

1. To determine if daily calf muscle stretching at home improves calf muscle and vascular health.
2. 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.

Full description

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

4-weeks of passive calf stretching for 30 minutes 5 days a week

Experimental group

Description:

A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.

Treatment:

Device: Passive calf muscle stretching device

4-weeks of no-stretching

No Intervention group

Description:

No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks.