Status:
RECRUITING
Passive Calf Stretching Therapy in Peripheral Artery Disease
Lead Sponsor:
Penn State University
Collaborating Sponsors:
American Heart Association
Conditions:
Peripheral Artery Disease
Claudication, Intermittent
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
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 d...
Detailed 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 functio...
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)
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06041880
Start Date
April 1 2024
End Date
July 1 2027
Last Update
July 31 2025
Active Locations (1)
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1
Penn State University
University Park, Pennsylvania, United States, 16802