Daily Step-based Exercise Using Fitness Monitors for Peripheral Artery Disease

Peripheral artery disease (PAD) is the third leading cause of cardiovascular morbidity,
following coronary artery disease and stroke. Symptoms of PAD include claudication, decreased
exercise capacity, progressive functional impairment, and decreased quality of life.
Structured exercise therapy is a cornerstone of treating symptomatic PAD. Guidelines
recommend a symptom-based exercise program that uses claudication to moderate walking
sessions.

Home exercise programs have demonstrated efficacy in improving walking ability and quality of
life for symptomatic PAD patients. In the general population and patients with certain
chronic diseases, walking more than 5,000 steps a day has been associated with better health.
The efficacy of walking more than 5,000 steps a day has not been well studied in symptomatic
PAD patients.

The EASY FIT Trial is a single-center prospective randomized controlled trial comparing the
effectiveness of a daily step-based exercise program (walking at least 5,000 steps a day) vs.
a guideline-recommended symptom-based exercise program (walking 45 consecutive minutes for 3
to 5 days a week), on improving walking ability and quality of life in patients with
symptomatic PAD. The study will enroll and randomize 40 patients with symptomatic PAD (20 to
each exercise program).The results of this study have the potential to create an effective,
safe, feasible, and sustainable exercise program that can help PAD patients have greater
walking ability and better quality of life.

Inclusion Criteria:

- Male or female, age 18 years or older

- Diagnosis of lower extremity PAD based on at least 1 of the following criteria:

- Ankle-brachial index (ABI) of 0.9 or less in one or both legs

- Invasive angiography demonstrating obstructive lower extremity artery disease

- Endovascular or surgical revascularization of lower extremity artery

- Symptomatic lower extremity PAD, characterized by 1 of the following:

- Fontaine Stage IIa: intermittent claudication after walking > 200 meters

- Fontaine Stage IIb: intermittent claudication after walking < 200 meters

- Have the availability of a suitable environment in which to walk

- Have a mobile phone with WiFi and Bluetooth capability

- Have the ability to read and speak the English language

Exclusion Criteria:

- Wheelchair bound

- Use of a walking aid (ie. cane, crutches, walker, motorized chair)

- Below or above the knee amputation

- Leg pain at rest

- Acute or critical limb ischemia

- Ischemic ulceration or gangrene

- Diabetes mellitus complicated by neuropathy

- Walking impairment due to another cause than PAD

- Ongoing evaluation for coronary artery disease (ie. awaiting a stress test or cardiac
catheterization)

- Active coronary artery disease requiring the initiation or uptitration of an
anti-anginal medication

- Angina with Canadian Cardiovascular Society (CCS) class 3-4 symptoms

- Myocardial infarction in the last 3 months

- Active congestive heart failure requiring the initiation or uptitration of diuretic
therapy

- Congestive heart failure with New York Heart Association (NYHA) class 3-4 symptoms

- Active arrhythmia requiring the initiation or uptitration of an anti-arrhythmic
medication

- Severe valve disease

- Active cancer or malignancy (not in remission)

- End-stage renal disease requiring hemodialysis or peritoneal dialysis

- Advanced liver disease, defined as cirrhosis

- Thyroid disease with abnormal TSH in the past 3 months

- Severe cognitive dysfunction, defined as dementia