Recruiting

Calf Stretching Therapy

Sponsor:

Penn State University

Code:

NCT06041880

Conditions

Peripheral Artery Disease

Claudication, Intermittent

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Passive calf muscle stretching device

Study Details

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 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

Peripheral Artery Disease

Claudication, Intermittent

Study ID

NCT06041880

Start date

Apr 1, 2024

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

Interventions

Passive calf muscle stretching device

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

Primary outcome measure

  • 6-minute walk test distance [ Time Frame: 6-12 minutes ]
  • Muscle to tendon ratio [ Time Frame: 45 minutes ]
  • Endothelial function [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

David N Proctor, Ph.D.

814-571-5234dnp3@psu.edu

Jocelyn M Delgado, B.S.

408-679-8390jmd956@psu.edu

Locations

Penn State University

Recruiting

University Park, Pennsylvania, United States, 16802

More Information

Sponsor

Penn State University

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • Endothelial dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Penn State University on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.