Clinical trial NCT03099369: Daily Step-based Exercise Using Fitness Monitors for Peripheral Artery Disease
Official title: The Effectiveness of Daily Step-based Exercise Therapy Using Fitness Monitors for Peripheral Artery Disease: The EASY FIT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: Peripheral Artery Disease
Peripheral Arterial Disease
Exercise
Step Count
Fitness Monitor
Mobile Health
Walking Ability
Quality of Life
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2017-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peripheral artery disease (PAD) is caused by blockages in the leg arteries. PAD limits patients' walking ability and quality of life. For patients with PAD, home exercise programs can improve walking ability and quality of life. In many patient populations, walking more than 5,000 steps a day is associated with better health. Currently, the benefit of walking more than 5,000 steps a day in patients with PAD has not been well studied.

The purpose of this clinical trial is to compare two different home exercise programs in patients with PAD: walking at least 5,000 steps a day with the help of fitness monitors vs. walking 45 consecutive minutes for 3 to 5 days a week (a common exercise prescription for PAD). This study has the potential to demonstrate that, with the help of fitness monitors, walking at least 5,000 steps a day can improve walking ability and quality of life for patients with PAD.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Mean Daily Walking Distance Over 7 Consecutive Days
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Change in the Peripheral Artery Questionnaire (PAQ) Summary Score
timeFrame: Baseline, Month 3
measure: Change in the Vascular Quality of Life Questionnaire (VascuQol) Summary Score
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: David W Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Prashant Kaul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: George A Stouffer, MD
role: PRINCIPAL_INVESTIGATOR
References: