NCT03099369: EASY FIT

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

Completed NA Results posted Last updated 12 November 2019

What this trial tests

NA trial testing Daily Step-based Exercise in Peripheral Artery Disease in 20 participants. Completed in 1 December 2018.

Timeline

1 June 2017

Primary endpoint
1 December 2018

1 December 2018

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 June 2017
Primary completion	1 December 2018
Estimated completion	1 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Daily Step-based Exercise
• Symptom-based Exercise
• Fitbit Fitness Monitor

Conditions studied

• Peripheral Artery Disease — all drugs for Peripheral Artery Disease →

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, any sex, with Peripheral Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Mean Daily Walking Distance Over 7 Consecutive Days Primary · Baseline, Month 3

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.

Group	Value	95% CI
Daily Step-based Exercise Group	754.2	± 1621.7
Symptom-based Exercise Group	-1160	± 2963.2

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mobile health technologies to improve walking distance in people with intermittent claudication.
   Elfghi M, Dunne D, Jones J, Gibson I, et al · · 2024 · cited 3× · PMID 38353263 · DOI 10.1002/14651858.cd014717.pub2