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

NCT ID: NCT03099369

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-12-01

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Daily Step-based Exercise

Intervention Type: BEHAVIORAL

A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.

Fitbit Fitness Monitor

Intervention Type: OTHER

Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only

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.

Group Type: ACTIVE_COMPARATOR

Symptom-based Exercise

Intervention Type: BEHAVIORAL

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

Fitbit Fitness Monitor

Intervention Type: OTHER

Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only

Interventions

Daily Step-based Exercise

A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.

Intervention Type: BEHAVIORAL

Symptom-based Exercise

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

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David W Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Prashant Kaul, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

George A Stouffer, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-3427

Identifier Type: -

Identifier Source: org_study_id