Daily Step-based Exercise Using Fitness Monitors for Peripheral Artery Disease (EASY FIT)

The Effectiveness of Daily Step-based Exercise Therapy Using Fitness Monitors for Peripheral Artery Disease: The EASY FIT Trial

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Behavioral: Daily Step-based Exercise; Other: Fitbit Fitness Monitor; Behavioral: Symptom-based Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daily Step-based Exercise Group; The experimental group will receive the following 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day (based on evidence that at least 5,000 a day is associated with better health). The Fitbit Fitness Monitor used for tracking.; Week 1: walk at least 3,000 steps every day.; Week 2: walk at least 3,500 steps every day.; Week 3: walk at least 4,000 steps every day.; Week 4: walk at least 4,500 steps every day.; Weeks 5-12: walk at least 5,000 steps every day.	Behavioral: Daily Step-based Exercise; A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.; Other: Fitbit Fitness Monitor; Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only
Active Comparator: Symptom-based Exercise Group; The active comparator group (ie. control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines).; Walk on a flat surface at a constant speed until there is mild to moderate pain; Rest until the pain has completely ceased; Resume walking at the same speed; Increase the speed when you can walk 8 minutes without stopping for leg symptoms; Continue this exercise routine for 45 consecutive minutes, 3 to 5 days a week.	Other: Fitbit Fitness Monitor; Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only; Behavioral: Symptom-based Exercise; A 12-week symptom-based exercise prescription adapted from clinical practice guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Mean Daily Walking Distance Over 7 Consecutive Days	At baseline, both groups will be instructed to wear their fitness monitors for 7 consecutive days. After 3 months of the exercise program, both groups will be instructed to wear their fitness monitors for 7 consecutive days. During each 7-day period, all patients will be instructed to walk continuously for at least one extended period of time on a daily basis. Given that this is a pilot study, the duration and frequency of these extended periods of time will be at the patients' discretion. The change in the mean daily walking distance at 3 months will be the primary outcome.	Baseline, Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Peripheral Artery Questionnaire (PAQ) Summary Score	At baseline, both groups will be asked to complete the Peripheral Artery Questionnaire (PAQ), which is a quality-of-life survey with a summary score ranging from 0 to 100 (with 100 indicating the highest quality of life). After 3 months of the exercise program, both groups will be asked to complete the PAQ again. The change in the summary score at 3 months will the secondary outcome.	Baseline, Month 3
Change in the Vascular Quality of Life Questionnaire (VascuQol) Summary Score	At baseline, both groups will be asked to complete the Vascular Quality of Life Questionnaire (VascuQol), which is a quality-of-life survey with a summary score ranging from 25 to 175 (with 175 indicating the highest quality of life). After 3 months of the exercise program, both groups will be asked to complete the VascuQol survey again. The change in the summary score at 3 months will the secondary outcome.	Baseline, Month 3

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Translational and Clinical Sciences Institute
• Investigators: Principal Investigator: George A Stouffer, MD, University of North Carolina; Principal Investigator: David W Lee, MD, University of North Carolina; Principal Investigator: Prashant Kaul, MD, University of North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Quality of Life; Mobile Health; Peripheral Artery Disease; Peripheral Arterial Disease; Walking Ability; Step Count; Fitness Monitor
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 16-3427

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No