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

NCT03099369 | Completed Results DMC

• 1 other identifier: 16-3427
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery Disease; Peripheral Arterial Disease; Exercise; Step Count; Fitness Monitor; Mobile Health; Walking Ability; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in the Peripheral Artery Questionnaire (PAQ) Summary Score

  Baseline, Month 3

• Change in the Vascular Quality of Life Questionnaire (VascuQol) Summary Score

  Baseline, Month 3

Study Arms (2)

Daily Step-based Exercise Group

EXPERIMENTAL

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; Other: Fitbit Fitness Monitor

Symptom-based Exercise Group

ACTIVE COMPARATOR

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.

Behavioral: Symptom-based Exercise; Other: Fitbit Fitness Monitor

Interventions

Daily Step-based Exercise BEHAVIORAL

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

Daily Step-based Exercise Group

Symptom-based Exercise BEHAVIORAL

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

Symptom-based Exercise Group

Fitbit Fitness Monitor OTHER

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

Daily Step-based Exercise Group; Symptom-based Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Results Point of Contact

• Title: David Lee, MD
• Organization: University of North Carolina at Chapel Hill

dave.lee0530@gmail.com

347-882-8010

Study Officials

• David W Lee, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Prashant Kaul, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• George A Stouffer, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-03

Locations

US (1)