Passive Calf Stretching Therapy in Peripheral Artery Disease

Not Applicable

Recruiting

• Conditions: Claudication, Intermittent; Peripheral Artery Disease
• Interventions: Device: Passive calf muscle stretching device

• Registration Number: NCT06041880
• Lead Sponsor: Penn State University

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.

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 Timeline

• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-11
• Study First Posted: 2023-09-18
• Study Start: 2024-04-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-30
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4-weeks of passive calf stretching for 30 minutes 5 days a week	Passive calf muscle stretching device	A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Penn State University; 🇺🇸 University Park, Pennsylvania, United States