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Behavioural Intervention

Calf Stretching Therapy for Peripheral Artery Disease

N/A
Recruiting
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women who are not pregnant or nursing
Stable condition (PAD symptoms) for at least 3 months
Must not have
Severe lung disease (on supplemental oxygen or frequently use rescue inhalers)
Major surgery or lower extremity revascularization surgery in the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 minutes
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate if calf stretching can improve calf muscle and vascular health, as well as walking performance, in patients with PAD.

Who is the study for?
This trial is for men and women aged 40-85 with stable peripheral artery disease (PAD) symptoms for at least three months. They must not be pregnant, nursing, or have had major surgeries recently. Excluded are those with uncontrolled diabetes, recent heart issues, habitual exercisers, ankle injuries within a year, severe lung disease, current smokers or nicotine users.
What is being tested?
The study tests if using an inflatable calf muscle stretching device at home can improve muscle and vascular health as well as walking performance in PAD patients. Participants will stretch daily for 30 minutes over four weeks followed by four weeks without stretching.
What are the potential side effects?
Potential side effects may include discomfort or pain from stretching the calf muscles too much. There might also be risks of worsening PAD symptoms due to increased activity levels during the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or nursing.
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My symptoms for peripheral artery disease have been stable for 3 months.
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I have peripheral artery disease (PAD).
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I am between 40 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I frequently use oxygen or rescue inhalers due to severe lung disease.
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I haven't had major or leg artery surgery in the last 6 months.
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My diabetes is not under control.
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I have had a heart attack or unstable chest pain in the last 6 months.
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My high blood pressure is not under control.
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I have a condition besides PAD that affects my walking.
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I have not been treated for a major illness in the last year.
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I cannot walk on a treadmill even at a slow pace.
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I have pain in my leg at rest due to poor blood flow, or I have ulcers or gangrene.
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I have a history of rheumatoid arthritis or similar joint conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
6-minute walk test distance
Endothelial function
Muscle to tendon ratio

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 4-weeks of passive calf stretching for 30 minutes 5 days a weekExperimental Treatment1 Intervention
A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.
Group II: 4-weeks of no-stretchingActive Control1 Intervention
No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks.

Find a Location

Who is running the clinical trial?

Penn State UniversityLead Sponsor
368 Previous Clinical Trials
127,539 Total Patients Enrolled
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,468 Total Patients Enrolled
10 Trials studying Peripheral Arterial Disease
834 Patients Enrolled for Peripheral Arterial Disease
~11 spots leftby Jul 2025
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