Actively Recruiting

Phase Not Applicable
Age: 40Years - 85Years
All Genders
NCT06041880

Passive Calf Stretching Therapy in Peripheral Artery Disease

Led by Penn State University · Updated on 2025-07-31

24

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

Sponsors

P

Penn State University

Lead Sponsor

A

American Heart Association

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Passive Calf Stretching Therapy in Peripheral Artery Disease

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of peripheral artery disease (PAD)
  • Stable PAD symptoms for at least 3 months
  • Age between 40 and 85 years
  • Men and women who are not pregnant or nursing
Not Eligible

You will not qualify if you...

  • Ischemic leg pain at rest or 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 requiring supplemental oxygen or frequent rescue inhalers
  • Non-compressible vessels (Ankle Brachial Index > 1.40)
  • Habitual exercise of 30 minutes continuous activity on 3 or more days per week
  • Current tobacco smoker or use of nicotine-containing products
  • Pregnant or nursing women
  • History of ankle reconstruction or surgery
  • Recent injuries (less than 1 year) to 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)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Penn State University

University Park, Pennsylvania, United States, 16802

Actively Recruiting

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Research Team

D

David N Proctor, Ph.D.

CONTACT

J

Jocelyn M Delgado, B.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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