Passive Calf Stretching Therapy in Peripheral Artery Disease

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06041880
• Other study ID #: 00022960
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: July 2026

Study information

• Verified date: March 2024
• Source: Penn State University
• Contact: David N Proctor, Ph.D.
• Phone: 814-571-5234
• Email: dnp3[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Claudication, Intermittent
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Passive calf muscle stretching device
Modified night splints will be used to passive stretch the calf muscle.

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

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