Passive Calf Stretching Therapy in Peripheral Artery Disease
NCT ID: NCT06041880
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2024-04-01
2027-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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4-weeks of passive calf stretching for 30 minutes 5 days a week
A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.
Passive calf muscle stretching device
Modified night splints will be used to passive stretch the calf muscle.
4-weeks of no-stretching
No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks.
No interventions assigned to this group
Interventions
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Passive calf muscle stretching device
Modified night splints will be used to passive stretch the calf muscle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable condition (PAD symptoms) for at least 3 months
* Age 40-85
* Men and women who are not pregnant or nursing
Exclusion Criteria
* 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)
40 Years
85 Years
ALL
No
Sponsors
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American Heart Association
OTHER
Penn State University
OTHER
Responsible Party
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David N. Proctor, PhD
Principal Investigator
Locations
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Penn State University
University Park, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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00022960
Identifier Type: -
Identifier Source: org_study_id
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