Calf Stretching for Peripheral Artery Disease

This study is looking at how passive calf muscle stretching might help people with peripheral artery disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to your limbs, often causing leg pain when walking (claudication). Researchers want to see if using a special device to stretch your calf muscles daily at home can improve your walking ability and the health of your calf muscles and blood vessels. You might be able to join if you are between 40 and 85 years old, have stable PAD symptoms, and are not pregnant or nursing. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 24 participants. It will test a passive calf muscle stretching device.
What's involved
Participants will use inflatable ankle splints for 30 minutes a day, 5 days a week for 4 weeks, followed by 4 weeks of no stretching. Measurements will include walking tests, muscle and tendon ratios, and endothelial function.
Compensation
Not stated in the trial record.
Follow-up
Walking distance will be measured at 6-12 minutes, muscle to tendon ratio at 45 minutes, and endothelial function at 30 minutes.

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NCT06041880

Passive Calf Stretching Therapy in Peripheral Artery Disease

Recruiting
NAAges 40–85InterventionalTreatment
Penn State University
~24 participants
Updated 2025-07-31 on ClinicalTrials.gov
What's tested:Passive calf muscle stretching device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6-minute walk test distance
Measured over 6-12 minutes
+2 more outcomes measured
Peripheral Artery Disease
Claudication, Intermittent
1 sites across 1 states
Pennsylvania1

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Eligibility criteria

Inclusion

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

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)
  • 6-minute walk test distance6-12 minutes

    Submaximal exercise test used to assess aerobic capacity and endurance

  • Muscle to tendon ratio45 minutes

    The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound

  • Endothelial function30 minutes

    Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg.