Calf stretching therapy for improving health in patients with peripheral artery disease
To Stretch, Not Strain: Impact of Passive Stretching on Calf Muscle and Gait Mechanics in PAD
This study is testing if using inflatable ankle splints to stretch calf muscles can help people with peripheral artery disease walk better and improve their leg health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Penn State University Academic / other |
| Locations | 1 site (University Park, Pennsylvania) |
| Trial ID | NCT06041880 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of passive calf muscle stretching on patients with peripheral artery disease (PAD). Participants will use inflatable ankle splints for 30 minutes daily, five days a week, over a four-week period to stretch their calf muscles. The study aims to assess improvements in calf muscle and vascular health, as well as walking performance. Measurements will include blood vessel health, calf muscle function, and oxygen levels during walking tests.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-85 with stable peripheral artery disease symptoms for at least three months.
Not a fit: Patients with critical limb ischemia, recent major surgeries, or other conditions severely limiting mobility may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could enhance walking ability and vascular health in patients with peripheral artery disease.
How similar studies have performed: While similar approaches have been explored, this specific passive stretching method in PAD patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
University Park, Pennsylvania
- Penn State University — University Park, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: David N Proctor, Ph.D.
- Email: dnp3@psu.edu
- Phone: 814-571-5234
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.