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

Peripheral Artery Disease Clinical Trial

— EASY FIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099369
• Other study ID #: 16-3427
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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.
• Symptom-based Exercise
A 12-week symptom-based exercise prescription adapted from clinical practice guidelines.

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

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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