CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Daily Step-based Exercise +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03099369
NCT03099369N/ACompleted

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

University of North Carolina, Chapel Hill·interventional·Posted Apr 4, 2017·Updated Nov 12, 2019

In Brief

A clinical study evaluating Daily Step-based Exercise, Symptom-based Exercise, and 1 other intervention for Peripheral Artery Disease. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 4, 2017
Enrollment StartJun 1, 2017
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.2 years ago

Interventions

Daily Step-based Exercisebehavioral

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

Symptom-based Exercisebehavioral

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

Fitbit Fitness Monitorother

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