search
Back to results

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

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily Step-based Exercise
Symptom-based Exercise
Fitbit Fitness Monitor
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Peripheral Artery Disease, Peripheral Arterial Disease, Exercise, Step Count, Fitness Monitor, Mobile Health, Walking Ability, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daily Step-based Exercise Group

Symptom-based Exercise Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 28, 2017
Last Updated
October 21, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03099369
Brief Title
Daily Step-based Exercise Using Fitness Monitors for Peripheral Artery Disease
Acronym
EASY FIT
Official Title
The Effectiveness of Daily Step-based Exercise Therapy Using Fitness Monitors for Peripheral Artery Disease: The EASY FIT Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
Peripheral Artery Disease, Peripheral Arterial Disease, Exercise, Step Count, Fitness Monitor, Mobile Health, Walking Ability, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily Step-based Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Symptom-based Exercise Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Daily Step-based Exercise
Intervention Description
A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.
Intervention Type
Behavioral
Intervention Name(s)
Symptom-based Exercise
Intervention Description
A 12-week symptom-based exercise prescription adapted from clinical practice guidelines.
Intervention Type
Other
Intervention Name(s)
Fitbit Fitness Monitor
Intervention Description
Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only
Primary Outcome Measure Information:
Title
Change in the Mean Daily Walking Distance Over 7 Consecutive Days
Description
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.
Time Frame
Baseline, Month 3
Secondary Outcome Measure Information:
Title
Change in the Peripheral Artery Questionnaire (PAQ) Summary Score
Description
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.
Time Frame
Baseline, Month 3
Title
Change in the Vascular Quality of Life Questionnaire (VascuQol) Summary Score
Description
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.
Time Frame
Baseline, Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Lee, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prashant Kaul, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George A Stouffer, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs