Recruiting

Exercise Intervention

Sponsor:

University of Oklahoma

Code:

NCT05712395

Conditions

Claudication

Peripheral Artery Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

Brief summary:

This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).

Conditions

Claudication

Peripheral Artery Disease

Study ID

NCT05712395

Start date

Sep 9, 2024

Status verified date

May, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Non-Ischemic Exercise (NICE) exercise program

Patients will perform supervised treadmill walking for 3 months. Patients randomized to the NICE program will walk intermittently at a slow speed of approximately 1.4 mph for only 2-3 minute bouts that do not elicit claudication pain.

active comparator: Standard exercise program

Patients will perform supervised treadmill walking for 3 months. Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain.

Interventions

Exercise

Non-Ischemic Exercise (NICE), pain-free exercise program will be compared to the Standard painful exercise program.

Primary outcome measure

  • Peak Walking Time [ Time Frame: 3 months ]
  • Calf Muscle Oxygen Saturation [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Contacts

More Information

Sponsor

University of Oklahoma

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-05-29.