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Could Pain-Free exercise help PAD patients walk better?

NCT ID NCT05712395

Symptom relief Sponsor: University of Oklahoma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new, pain-free exercise program for people with peripheral artery disease (PAD), which causes leg pain when walking. Researchers will compare it to standard painful exercise over 3 months in 100 adults aged 40 and older. The goal is to see if the pain-free program improves walking time and calf muscle oxygen levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Non-Ischemic Exercise (NICE) program
What this could lead to
If it works, this could offer a more comfortable exercise option for people with PAD, helping them walk farther without pain.
What could go wrong
This is a small, early-stage study (100 people) comparing two exercise programs. The new program may not be more effective than standard exercise, and results may not apply to all PAD patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. history of claudication assessed by the Walking Impairment Questionnaire, 2. ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol, 3. an ABI \<= 0.90 at rest or \> 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test. 4. age \>= 40 years. Exclusion Criteria: 1. absence of PAD (ABI \> 0.90 at rest and ankle systolic blood pressure \< 20% decrease after exercise, 2. inability to obtain an ABI measure due to non-compressible vessels (ABI \> 1.40), 3. asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test, 4. rest pain due to PAD (Fontaine stage III) 5. tissue loss due to PAD (Fontaine stage IV) 6. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation, 7. peripheral revascularization within one month prior to investigation, or peripheral revascularization performed during the study, 8. exercise tolerance limited by any disease process other than PAD, 9. active cancer, 10. kidney failure defined as stage 5 chronic kidney disease, 11. a calf skin fold measurement \> 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue, 12. pulse arterial oxygen saturation of the index finger \< 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and 13. failure to complete the baseline run-in phase within three weeks.

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Conditions

The condition(s) this trial relates to.

intermittent vascular claudication peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Claudication Peripheral artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • O'Donoghue Research Building, University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73117, United States

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