Using pneumatic compression and exercise to improve walking in patients with peripheral artery disease

Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease: The INTERCEDE TRIAL

This study is testing if using a special compression device along with walking exercises can help people with peripheral artery disease walk further and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 55 Years and up
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Locations: 4 sites (Chicago, Illinois and 3 other locations)
• Trial ID: NCT03871075 on ClinicalTrials.gov

What this trial studies

The INTERCEDE trial investigates the effectiveness of intermittent pneumatic compression combined with walking exercise to enhance walking endurance in individuals with lower extremity peripheral artery disease (PAD). Participants will be randomly assigned to one of four groups: receiving both pneumatic compression and exercise, pneumatic compression without exercise, exercise with a sham device, or sham device without exercise. The study aims to measure changes in walking distance after six months and assess whether the benefits of pneumatic compression persist after treatment. Additionally, the trial will explore the underlying mechanisms of improvement through MRI and vascular function assessments.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with peripheral artery disease, as defined by specific ankle-brachial index criteria.

Not a fit: Patients with critical limb ischemia or those who have undergone amputation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve walking endurance and quality of life for patients with peripheral artery disease.

How similar studies have performed: Previous studies have shown promise in using pneumatic compression for similar conditions, but this specific combination approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

All participants will have PAD. PAD will be defined as follows: first, an ankle-brachial index (ABI) \< or = 0.90 at the baseline study visit is an inclusion criterion for PAD. Second, potential participants with an ABI \>0.90 who have vascular laboratory evidence of PAD. Vascular laboratory evidence consists of objective evidence of PAD, including toe brachial index (TBI) \< or = 0.70, Duplex measure showing 70% stenosis or greater, or ABI values \< 0.90. Abnormal waveforms or pulse volume recordings alone from a non-invasive vascular laboratory test will not be sufficient for enrollment. Third, potential participants with an ABI \>0.90 who have angiographic evidence of PAD consisting of a stenosis of 70% or greater in a lower extremity artery.

Exclusion Criteria:

1. Above- or below-knee amputation.
2. Critical limb ischemia or ABI \< 0.30 in the setting of ischemic symptoms at rest or physical examination findings consistent with critical limb ischemia. Some potential participants with symptoms or signs of critical limb ischemia may be excluded at the principal investigator's discretion if the ABI is 0.30 or higher.
3. Wheelchair-bound.
4. Current foot ulcer on bottom of foot.
5. Walking is primarily limited by a symptom other than PAD.
6. Failure to successfully complete the study run-in.
7. Major surgery, revascularization, or orthopedic surgery in the past 3 months or planned in the next 12 months.
8. Major medical illness including Parkinson's Disease, lung disease requiring oxygen, cancer requiring treatment in the previous two years, or life-threatening illness with a life expectancy of less than six months. Participants who only use oxygen at night will be potentially eligible. \[NOTE: potential participants treated for cancer in the past two years may still qualify if they have had treatment for early stage cancer in the past two years and the prognosis is excellent. Potential participants treated for basal cell or squamous cell skin cancer will not be excluded.\]
9. Already exercising at a level consistent with exercise intervention. Current or recent participation in exercise rehabilitation (within the past three months).
10. Recently diagnosed (within the past three months) with acute lower extremity deep venous thrombosis, pulmonary embolism, or severe heart failure (i.e. New York Heart Association (NYHA) Class III or IV).
11. Mini-Mental Status Examination (MMSE) score \<23 or dementia.
12. Participation in or completion of a clinical trial in the previous three months.
13. Non-English speaking.
14. Increase in angina in the past month, angina at rest, or abnormal baseline treadmill stress test. Potential participants may become eligible after an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing (such as a stress test with imaging or a coronary angiogram) from a test performed with their own physician and if they do not have symptoms of unstable angina. The evidence of absent coronary ischemia, based on an imaging stress test or coronary angiogram, must have been performed within the previous year.
15. Ongoing infection of the toes, foot, or lower extremity.
16. Potential participants who started on cilostazol within the last three months. They may be evaluated for eligibility once three months have passed since beginning cilostazol.
17. Significant peripheral edema, defined as 3+ or greater edema severity, as determined by the principal investigator.
18. BMI \>45 kg/M2
19. Significant visual impairment that interferes with walking.
20. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.

Where this trial is running

Chicago, Illinois and 3 other locations

• Northwestern University — Chicago, Illinois, United States (Recruiting)
• University of Chicago — Chicago, Illinois, United States (Recruiting)
• Henry Ford Health — Detroit, Michigan, United States (Recruiting)
• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Mary McDermott, MD — Northwestern Universtiy
• Study coordinator: Kathryn Domanchuk, BS

Conditions Peripheral Artery Disease; peripheral arterial disease; PAD; exercise; Intermittent claudication