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

Peripheral Artery Disease Clinical Trial

— NICE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05712395
• Other study ID #: 16294
• Secondary ID: R01AG071778-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 9, 2024
• Est. completion date: July 31, 2028

Study information

• Verified date: June 2024
• Source: University of Oklahoma
• Contact: Andrew W. Gardner, Ph.D.
• Phone: 405-271-4742
• Email: andrew-gardner[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Specific Aims. The investigator proposes to test our central hypothesis that the NICE intervention performed without inducing leg ischemia and its' damaging sequela will be a superior exercise paradigm to increase peak walking time and HRQoL more than the Standard ischemic and painful exercise paradigm via greater improvement in microvascular mechanisms. This clinically relevant hypothesis will be tested through the following aims:

Aim 1 (Exercise Outcomes) To compare the changes in ambulation and HRQoL in PAD patients randomized to either the NICE slow walking program or to the Standard program of ischemic and painful exercise.

Aim 2a (Vascular Outcomes) To compare the changes in local microvascular function of the lower extremities, inflammation and oxidative stress in patients following the NICE program, and following the Standard ischemic and painful program.

Aim 2b (Exploratory Aim) To explore whether the changes in local microvascular function and systemic vascular biomarkers are associated with the changes in peak walking time following the NICE and Standard programs, and whether the association is stronger following the NICE program.

Methods. This is a 3-month, patient-oriented, translational, comparative effectiveness randomized controlled trial. One-hundred patients will be randomized into either the NICE program (N=50) or the Standard exercise program (N=50). All 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. Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 31, 2028
• Est. primary completion date: July 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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 >= 60 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.

Related Conditions & MeSH terms

• Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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

Locations

Country	Name	City	State
United States	O'Donoghue Research Building, University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
University of Oklahoma	Case Western Reserve University, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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( — View Citation

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/CI — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Walking Time	The change in peak walking time from the pre-test value to the post-test value (seconds)	3 months
Primary	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	6-Minute Walk Distance	The change in 6-minute walk distance from the pre-test value to the post-test value (meters)	3 months
Secondary	plasma C-Reactive Protein	The change in plasma C-reactive protein from the pre-test value to the post-test value (mg/L)	3 months