Peripheral Artery DiseaseNCT06041880
Passive Calf Stretching Therapy in Peripheral Artery Disease
A study testing Passive calf muscle stretching device in people with Peripheral Artery Disease and Claudication, Intermittent, run by Penn State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Peripheral Artery Disease, Claudication, Intermittent
- What is being tested?
- Passive calf muscle stretching device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of PAD
- Stable condition (PAD symptoms) for at least 3 months
- Age 40-85
- Men and women who are not pregnant or nursing
Who cannot join
- 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)
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: To Stretch, Not Strain: Impact of Passive Stretching on Calf Muscle and Gait Mechanics in PAD
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:
- To determine if daily calf muscle stretching at home improves calf muscle and vascular health.
- 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.
Read the detailed 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.
- Being tested
- Passive calf muscle stretching device
- Keywords
- Endothelial dysfunction
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive calf muscle stretching deviceDevice
Also called Plantar fasciitis night splints
Modified night splints will be used to passive stretch the calf muscle.
| Study group | Role | What they receive |
|---|---|---|
| 4-weeks of passive calf stretching for 30 minutes 5 days a week | Experimental | A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle. Receives: Device: Passive calf muscle stretching device |
| 4-weeks of no-stretching | No intervention | No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test distance
Submaximal exercise test used to assess aerobic capacity and endurance
Measured: 6-12 minutes
Muscle to tendon ratio
The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound
Measured: 45 minutes
Endothelial function
Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Apr 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to 4-weeks of stretching or no stretching. Following the first 4-week intervention, participants will crossover and perform whichever intervention they did not receive previously.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, David N. Proctor, PhD, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041880
- Sponsor's protocol ID
- 00022960
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Stretch, Not Strain: Impact of Passive Stretching on Calf Muscle and Gait Mechanics in PAD
- ClinicalTrials.gov ID
- NCT06041880
- Acronym / sponsor ID
- 00022960
- Keywords
- Endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine if daily calf muscle stretching at home improves calf muscle and vascular health.
- 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to 4-weeks of stretching or no stretching. Following the first 4-week intervention, participants will crossover and perform whichever intervention they did not receive previously.
| Arm | Type | Receives |
|---|---|---|
| 4-weeks of passive calf stretching for 30 minutes 5 days a week | Experimental | Device: Passive calf muscle stretching deviceA modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle. |
| 4-weeks of no-stretching | No intervention | –No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of PAD
- Stable condition (PAD symptoms) for at least 3 months
- Age 40-85
- Men and women who are not pregnant or nursing
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive calf muscle stretching deviceAlso: Plantar fasciitis night splintsModified night splints will be used to passive stretch the calf muscle. | Device | 4-weeks of passive calf stretching for 30 minutes 5 days a week |
Primary outcome
6-minute walk test distance
Time frame: 6-12 minutes
Submaximal exercise test used to assess aerobic capacity and endurance
Muscle to tendon ratio
Time frame: 45 minutes
The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound
Endothelial function
Time frame: 30 minutes
Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive calf muscle stretching device in people with Peripheral Artery Disease and Claudication, Intermittent, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David N Proctor, Ph.D. (814-571-5234, dnp3@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test distance (time frame: 6-12 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.