The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease

NCT05712395 | Recruiting

• 2 other identifiers: 16294R01AG071778-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Peak Walking Time

  The change in peak walking time from the pre-test value to the post-test value (seconds)

  3 months

• Calf Muscle Oxygen Saturation

  The change in calf muscle oxygen saturation value during exercise from the pre-test value to the post-test value (% saturation)

  3 months

Secondary Outcomes (2)

• 6-Minute Walk Distance

  3 months

• plasma C-Reactive Protein

  3 months

Study Arms (2)

Non-Ischemic Exercise (NICE) exercise program

EXPERIMENTAL

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.

Behavioral: Exercise

Standard exercise program

ACTIVE COMPARATOR

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.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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

Non-Ischemic Exercise (NICE) exercise program; Standard exercise program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• history of claudication assessed by the Walking Impairment Questionnaire,
• 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,
• 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.
• age \>= 60 years.

You may not qualify if:

• absence of PAD (ABI \> 0.90 at rest and ankle systolic blood pressure \< 20% decrease after exercise,
• inability to obtain an ABI measure due to non-compressible vessels (ABI \> 1.40),
• asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,
• rest pain due to PAD (Fontaine stage III)
• tissue loss due to PAD (Fontaine stage IV)
• use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
• peripheral revascularization within one month prior to investigation, or peripheral revascularization performed during the study,
• exercise tolerance limited by any disease process other than PAD,
• active cancer,
• kidney failure defined as stage 5 chronic kidney disease,
• a calf skin fold measurement \> 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue,
• pulse arterial oxygen saturation of the index finger \< 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and
• failure to complete the baseline run-in phase within three weeks.

Sponsors & Collaborators

• University of Oklahoma: lead
• Case Western Reserve University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

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

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

Related Publications (2)

• Gardner AW, Parker DE, Montgomery PS, Scott KJ, Blevins SM. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation. 2011 Feb 8;123(5):491-8. doi: 10.1161/CIRCULATIONAHA.110.963066. Epub 2011 Jan 24.

  PMID: 21262997 RESULT

• Gardner AW, Parker DE, Montgomery PS, Blevins SM. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J Am Heart Assoc. 2014 Sep 18;3(5):e001107. doi: 10.1161/JAHA.114.001107.

  PMID: 25237048 RESULT

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Andrew W. Gardner, Ph.D

  Professor, Department of Medicine, Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew W. Gardner, Ph.D.

CONTACT

405-271-4742; andrew-gardner@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized controlled clinical trial

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: September 9, 2024
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)