Passive Calf Stretching Therapy in Peripheral Artery Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease; Claudication, Intermittent
• Intervention / Treatment: Device: Passive calf muscle stretching device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David N Proctor, Ph.D.; Phone Number: 814-571-5234; Email: dnp3@psu.edu
• Study Contact Backup: Name: Jocelyn M Delgado, B.S.; Phone Number: 408-679-8390; Email: jmd956@psu.edu

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Recruiting
      • Penn State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Passive calf muscle stretching device; Modified night splints will be used to passive stretch the calf muscle.; Other Names: Plantar fasciitis night splints
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test distance	Submaximal exercise test used to assess aerobic capacity and endurance	6-12 minutes
Muscle to tendon ratio	The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound	45 minutes
Endothelial function	Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg.	30 minutes

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: American Heart Association

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Endothelial dysfunction
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: 00022960

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No