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NCT Number: NCT06041880

Passive Calf Stretching Therapy in Peripheral Artery Disease

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Passive calf muscle stretching device

Device

Modified night splints will be used to passive stretch the calf muscle.

Other names: Plantar fasciitis night splints

Primary outcomes

  1. 6-minute walk test distance

    Time frame: 6-12 minutes

    Submaximal exercise test used to assess aerobic capacity and endurance

  2. Muscle to tendon ratio

    Time frame: 45 minutes

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

  3. Endothelial function

    Time frame: 30 minutes

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

Study contacts

Contact information is provided by the study sponsor or research team.

David N Proctor, Ph.D.

CONTACT

[email protected]

814-571-5234

Jocelyn M Delgado, B.S.

CONTACT

[email protected]

408-679-8390

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

To Stretch, Not Strain: Impact of Passive Stretching on Calf Muscle and Gait Mechanics in PAD

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 18, 2023
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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