Peripheral Artery Disease (PAD)STRETCH PADNCT07919483
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
A study testing Therapeutic calf stretching in people with Peripheral Artery Disease (PAD) and Intermittent Claudication, run by Penn State University at 2 sites in United States.
Trial summary
The goal of this multi-center clinical trial is to assess the effects of passive calf muscle stretching in older adults diagnosed with peripheral artery disease (PAD). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Artery Disease (PAD), Intermittent Claudication
- What is being tested?
- Therapeutic calf stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2027to Dec 2032
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female. Women must not be pregnant, nor plan to become pregnant or be breast feeding
- Agree to participate voluntarily and sign an IRB approved consent form.
- ≥50 years of age
- Individuals with peripheral artery disease. Objective evidence of PAD: ankle brachial index (ABI)<0.9 at rest; or any other diagnostic test confirming PAD including but not limited to hemodynamic or imaging modalities confirming PAD.
- PAD presentation or symptomatology consistent with Fontaine Stage IIa or IIb (intermittent claudication pain).
- PAD symptoms must be stable for at least 3 months to exclude acute thrombotic events.
- A peak walking time (PWT) < 360 seconds on a graded 6-minutes treadmill walking protocol
Who cannot join
- Terminal illness (<12-month life expectancy)
- Inability to provide inform consent
- Uncontrolled arrhythmias
- Inability to cooperate during exams
- Significant infection or inflammation
- Currently engaged in a structured, organized, and supervised physical training program
Show all 21Show fewer
- Enrolled in an interventional trial on PAD
- Scheduled to undergo revascularization or major elective surgery within the next 6 months
- Current critical limb ischemia or above/below-knee amputation, wheelchair-bound, or requires the use of a walker or cane
- Underwent lower extremity revascularization, or coronary artery bypass surgery within 3 months of screening
- Underwent major orthopedic surgery within 6 months of screening
- End stage renal disease (requiring dialysis)
- Significant hepatic dysfunction (AST and/or ALT >5xULN, bilirubin >2xULN)
- Parkinson's disease
- Recent history of alcohol or drug abuse
- Inability to walk on a treadmill
- Advanced heart failure: New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction < 30%),
- Severe or very severe COPD (forced expiratory volume (FEV-1) ≤ 50%)
- Severe pulmonary condition that requires oxygen
- Resting SpO₂ ≤92% or ≥4% desaturation with exercise
- ≥1 mm ST depression/elevation (abnormal ECG finding)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, 17033
Gerd Brunner, PhD, 717-531-0003 ext. 289803, gbrunner@pennstatehealth.psu.edu
David N Proctor, PhD, 814-571-5234, dnp3@psu.edu
Kansas State University
Manhattan, Kansas, 66056
Carl Ade, PhD, 785-532-1127, cade@ksu.edu
Judy Muller-Delp, PhD, 785-532-5666, mullerdelp@ksu.edu
About this study
Official title: Daily Stretching to Improve Walking and Calf Muscle Function in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
The goal of this multi-center clinical trial is to assess the effects of passive calf muscle stretching in older adults diagnosed with peripheral artery disease (PAD). The main questions it aims to answer are:
- To determine how calf muscle stretching at home affects treadmill walk performance and daily physical activity level after 4 weeks and 6 months in these patients.
- To determine how calf muscle stretching at home affects calf muscle vascular function and walking gait.
Participants will use inflatable ankle stretch boots for 30 minutes a day, 5 days a week for 4-weeks
Read the detailed description
Patients with peripheral artery disease will passively stretch their calf muscles using a stretch device on both feet while seated for 30 minutes a day for 4 weeks at home. Peak treadmill walk time, calf macro- and micro-vascular function, walking gait pattern, and daily physical activity will be measured at baseline, 4 weeks, and 6 months.
- Being tested
- Therapeutic calf stretching, Sham calf stretching
- Keywords
- 6 min walk test, Microcirculation, Muscular stretching
- 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.
Therapeutic calf stretchingBehavioural
Participants will wear calf stretch boots for 4 weeks (30 minutes per day, 5 days per week) at 90% of maximal tolerable stretch.
Sham calf stretchingBehavioural
Participants will wear calf stretch boots for 4 weeks (30 minutes per day, 5 days per week) at approximately 10% of maximal tolerable stretch.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic calf stretching | Experimental | Seated bilateral static calf stretching at 90% of maximal tolerated stretch intensity with both feet resting on a second chair (knees extended). This will be performed at home 30 minutes per day, 5 days per week, for 4 weeks. Receives: Behavioral: Therapeutic calf stretching |
| Sham calf stretching | Sham comparator | Seated bilateral static calf stretching at a minimal stretch intensity with both feet resting on the floor (knees bent). This will be performed at home 30 minutes per day, 5 days per week, for 4 weeks. Receives: Behavioral: Sham calf stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak treadmill walking distance
Change from baseline in continuous walking distance (meters) during the treadmill walking test protocol
Measured: Baseline, 4 weeks, and 24 weeks
Change in calf muscle microvascular function
Change from baseline in calf muscle re-oxygenation (%SmO2) after the 5 minute vascular occlusion test
Measured: Baseline, 4 weeks, and 24 weeks
Change in peak normalized average forefoot force during a self-selected walking pace
Change from baseline in ground reaction force during a self-selected level ground walking pace
Measured: Baseline, 4 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease (PAD)Studies 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
- Parallel groups
- Model description
- Participants with peripheral artery disease will be randomized in a 1:1 ratio to receive either therapeutic calf stretching (90% of maximal tolerable stretch) or sham calf stretching (minimal, approximately 10% of maximal tolerable stretch) using stretch boots worn 30 minutes per day, 5 days per week, for 4 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David N. Proctor, PhD, Penn State University
- Investigators
- David N Proctor, PhD, Principal investigator, The Pennsylvania State UniversityGerd Brunner, PhD, Principal investigator, Pennsylvania State University College of MedicineCarl Ade, PhD, Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919483
- Sponsor's protocol ID
- 259266
- Acronym
- STRETCH PAD
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared under controlled-access conditions. De-identified individual participant data from published results will be made available to qualified researchers upon reasonable request and following completion of an appropriate data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Stretching to Improve Walking and Calf Muscle Function in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
- ClinicalTrials.gov ID
- NCT07919483
- Acronym / sponsor ID
- STRETCH PAD / 259266
- Keywords
- 6 min walk test, Microcirculation, Muscular stretching
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 5 Nov 2026 (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 multi-center clinical trial is to assess the effects of passive calf muscle stretching in older adults diagnosed with peripheral artery disease (PAD). The main questions it aims to answer are:
- To determine how calf muscle stretching at home affects treadmill walk performance and daily physical activity level after 4 weeks and 6 months in these patients.
- To determine how calf muscle stretching at home affects calf muscle vascular function and walking gait.
Participants will use inflatable ankle stretch boots for 30 minutes a day, 5 days a week for 4-weeks
Detailed description
Patients with peripheral artery disease will passively stretch their calf muscles using a stretch device on both feet while seated for 30 minutes a day for 4 weeks at home. Peak treadmill walk time, calf macro- and micro-vascular function, walking gait pattern, and daily physical activity will be measured at baseline, 4 weeks, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants with peripheral artery disease will be randomized in a 1:1 ratio to receive either therapeutic calf stretching (90% of maximal tolerable stretch) or sham calf stretching (minimal, approximately 10% of maximal tolerable stretch) using stretch boots worn 30 minutes per day, 5 days per week, for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic calf stretching | Experimental | Behavioral: Therapeutic calf stretchingSeated bilateral static calf stretching at 90% of maximal tolerated stretch intensity with both feet resting on a second chair (knees extended). This will be performed at home 30 minutes per day, 5 days per week, for 4 weeks. |
| Sham calf stretching | Sham comparator | Behavioral: Sham calf stretchingSeated bilateral static calf stretching at a minimal stretch intensity with both feet resting on the floor (knees bent). This will be performed at home 30 minutes per day, 5 days per week, for 4 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult male or female. Women must not be pregnant, nor plan to become pregnant or be breast feeding
- Agree to participate voluntarily and sign an IRB approved consent form.
- ≥50 years of age
- Individuals with peripheral artery disease. Objective evidence of PAD: ankle brachial index (ABI)<0.9 at rest; or any other diagnostic test confirming PAD including but not limited to hemodynamic or imaging modalities confirming PAD.
- PAD presentation or symptomatology consistent with Fontaine Stage IIa or IIb (intermittent claudication pain).
Key exclusion criteria (21 listed)
- Terminal illness (<12-month life expectancy)
- Inability to provide inform consent
- Uncontrolled arrhythmias
- Inability to cooperate during exams
- Significant infection or inflammation
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 |
|---|---|---|
| Therapeutic calf stretchingParticipants will wear calf stretch boots for 4 weeks (30 minutes per day, 5 days per week) at 90% of maximal tolerable stretch. | Behavioural | Therapeutic calf stretching |
| Sham calf stretchingParticipants will wear calf stretch boots for 4 weeks (30 minutes per day, 5 days per week) at approximately 10% of maximal tolerable stretch. | Behavioural | Sham calf stretching |
Primary outcome
Change in peak treadmill walking distance
Time frame: Baseline, 4 weeks, and 24 weeks
Change from baseline in continuous walking distance (meters) during the treadmill walking test protocol
Change in calf muscle microvascular function
Time frame: Baseline, 4 weeks, and 24 weeks
Change from baseline in calf muscle re-oxygenation (%SmO2) after the 5 minute vascular occlusion test
Change in peak normalized average forefoot force during a self-selected walking pace
Time frame: Baseline, 4 weeks, and 24 weeks
Change from baseline in ground reaction force during a self-selected level ground walking pace
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 5 Nov 2026.
- Individual participant dataSharing planned: Yes. IPD will be shared under controlled-access conditions. De-identified individual participant data from published results will be made available to qualified researchers upon reasonable request and following completion of an appropriate data use agreement.
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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.
David N Proctor, PhD principal investigator
The Pennsylvania State University
Gerd Brunner, PhD principal investigator
Pennsylvania State University College of Medicine
Carl Ade, PhD principal investigator
Kansas State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic calf stretching in people with Peripheral Artery Disease (PAD) and Intermittent Claudication, run by Penn State University at 2 sites 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 7 inclusion and 21 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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, PhD (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?
Change in peak treadmill walking distance (time frame: Baseline, 4 weeks, and 24 weeks). 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 5 Nov 2026.