Actively Recruiting
To Stretch, Not Strain: Impact of Passive Stretching on Calf Muscle and Gait Mechanics in Peripheral Artery Disease
Led by Penn State University · Updated on 2025-07-31
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Penn State University
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of passive calf muscle stretching in people diagnosed with peripheral artery disease (PAD). The study aims to determine if daily calf muscle stretching at home can improve calf muscle and blood vessel health, as well as walking ability. The trial is led by Penn State University and involves participants aged 40 to 85 years. Participants will use a modified plantar fasciitis ankle splint to passively stretch their calf muscles on both feet for 30 minutes a day, five days a week, over a period of four weeks. Another group will not use the stretching device and will continue their usual daily activities for four weeks. The study compares the effects of stretching versus no stretching. Throughout the study, researchers will measure walking performance using a 6-minute walk test, assess muscle and tendon size, and evaluate blood vessel function. Joint and foot movements, as well as calf muscle oxygen levels, will be monitored during walking tests. Participants will be involved for at least eight weeks, including four weeks of stretching or no stretching and assessments before and after these periods.
CONDITIONS
Brief Title
Passive Calf Stretching Therapy in Peripheral Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of peripheral artery disease
- Stable PAD symptoms for at least 3 months
- Age between 40 and 85 years
- Men and women who are not pregnant or nursing
You will not qualify if you...
- Ischemic leg pain at rest or critical limb ischemia (ulceration or gangrene)
- Any condition other than PAD that limits walking ability
- Major surgery or lower extremity revascularization within past 6 months
- Myocardial infarction within past 6 months or unstable angina
- Severe lung disease requiring supplemental oxygen or frequent rescue inhaler use
- Non-compressible vessels with ABI greater than 1.40
- Habitual exercise of 30 minutes continuous activity on 3 or more days per week
- Current tobacco smoker or use of nicotine products
- Pregnant or nursing women
- History of ankle reconstruction or surgery
- Recent injuries (within 1 year) to ankle, Achilles tendon, or feet
- History of rheumatoid arthritis or other degenerative joint diseases
- Major medical illness treatment in the prior 12 months
- Uncontrolled hypertension
- Uncontrolled diabetes
- Inability to walk on a treadmill at a slow pace (1.0 mile/hour)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two 4-week periods with and without stretching
Participants will use a passive calf stretching device to stretch their calf muscles for 30 minutes a day, 5 days a week, for 4 weeks. During a different 4-week period, participants will not use the device and continue their normal daily activities.
Visits scheduled as needed to monitor device use and walking performance
Duration - Up to 12 minutes for walking tests and 45 minutes for muscle assessments per visit
Participants’ blood vessel health, calf muscle and tendon function, and walking performance will be assessed after each treatment period.
Assessment visits following each treatment period
Trial Site Locations
Total: 1 location
1
Penn State University
University Park, Pennsylvania, United States, 16802
Actively Recruiting
Research Team
D
David N Proctor, Ph.D.
J
Jocelyn M Delgado, B.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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