Passive Calf Stretching Therapy in Peripheral Artery Disease

NCT ID: NCT06041880

Last Updated: 2025-07-31

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2027-07-31

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:

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.

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.

Conditions

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Peripheral Artery Disease Claudication, Intermittent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Due to the nature of the intervention, participants will not be blinded to stretching vs no-stretching interventions. The study team will be blinded to intervention order when performing data analysis.

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.

Group Type EXPERIMENTAL

Passive calf muscle stretching device

Intervention Type 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.

Group Type NO_INTERVENTION

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.

Intervention Type DEVICE

Other Intervention Names

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Plantar fasciitis night splints

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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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David N. Proctor, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Penn State University

University Park, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David N Proctor, Ph.D.

Role: CONTACT

814-571-5234

Jocelyn M Delgado, B.S.

Role: CONTACT

408-679-8390

Other Identifiers

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00022960

Identifier Type: -

Identifier Source: org_study_id

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