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Behavioural Intervention

Calf Stretching Therapy for Peripheral Artery Disease

N/A
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 minutes
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
355 Previous Clinical Trials
125,733 Total Patients Enrolled
American Heart AssociationOTHER
324 Previous Clinical Trials
4,933,754 Total Patients Enrolled
9 Trials studying Peripheral Arterial Disease
804 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the requirements to partake in this experiment?

"The requirements for this investigation necessitate that eligible participants are afflicted with peripheral arterial disease and are of ages 40 to 85. This study is planning on recruiting approximately 24 candidates."

Answered by AI

Is recruitment for this trial currently in progress?

"Data on clinicaltrials.gov suggests that, as of September 15th 2023, this trial is not presently taking applicants. This study was initially posted on October 1st 2023 and the number of open trials stands at 219."

Answered by AI

Is the age criterion for participation in this trial limited to those under 60 years?

"This research study has established the age range of 40 to 85 years old as its inclusion criteria. Additionally, there are 9 studies for individuals younger than 18 and 211 trials dedicated to those over 65."

Answered by AI

Who else is applying?

What site did they apply to?
Penn State University
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

There has been 3 attempts to get past my left knee. Unsuccessful.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Passive Calf Stretching Therapy in Peripheral Artery Disease
David N. Proctor, PhD 2024. "Passive Calf Stretching Therapy in Peripheral Artery Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06041880.
All > Pad
~16 spots leftby Jul 2025
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