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

NCT03099369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-11-12

Study results available
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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

Interventions

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.

BEHAVIORAL

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

Sponsors & Collaborators

  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • David W Lee, MD · University of North Carolina

  • Prashant Kaul, MD · University of North Carolina

  • George A Stouffer, MD · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2018-12-01
Completion
2018-12-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03099369 on ClinicalTrials.gov