NCT04633538: 6-APP

Evaluation of a New 6 Minute Walk Test Smartphone App in Patients With Pulmonary Hypertension

Completed Results posted Last updated 7 March 2025

What this trial tests

trial testing 6MWT smartphone app in Pulmonary Hypertension in 30 participants. Completed in 1 April 2020.

Timeline

15 January 2018

Primary endpoint
28 August 2019

1 April 2020

Quick facts

Lead sponsor	Oxford University Hospitals NHS Trust
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	15 January 2018
Primary completion	28 August 2019
Estimated completion	1 April 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• 6MWT smartphone app

Conditions studied

• Pulmonary Hypertension — all drugs for Pulmonary Hypertension →

Sponsor

Oxford University Hospitals NHS Trust

Who can join

18 and older, any sex, with Pulmonary Hypertension. 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.

Percentage of Participants Who Perform App-based Home 6MWT Primary · 6 months

Percentage of participants who perform app-based home 6MWT.

Group	Value	95% CI
6MWT App Group	30

Difference in Walked Distance Between 6MWT Test at the Clinic as Measured by Physiologists and the App in Indoor Mode Secondary · At start, at month 3 and at month 6.

Comparison of the indoor app-based 6MWD against simultaneous clinic 6MWD: mean and standard deviation of the difference in distance as measured by physiologists and the app. Differences at 3 time points (start, month 3 and month 6) are lumped together in the calculation of the statistics (mean and standard deviation).

Group	Value	95% CI
6MWT App Group	14.6	± 75.48

Difference in Walked Distance Between 6MWT Test as Measured by Physiologists at the Clinic and App in Outdoor Mode at the Community Secondary · Clinic tests at start, at month 3, at month 6. Community tests undertaken within 7 days of clinic test.

Comparison of pairs of 6MWT distance estimates where one is the result of an observation done by a physiologist in a clinic (start, month 3 and month 6) and the other is measured by the app during an outdoor test performed within 7 days of the physiologist's observation. Measurements at 3 time points (start, month 3 and month 6) are lumped together in the calculation of the statistics (mean and standard deviation).

Group	Value	95% CI
6MWT App Group	2.45	± 47.0

Test-Retest Reliability of Community-Based 6MWT Secondary · 6MWT in the community, at the patient's discretion (recommended once/month), over 6 months

Intraclass correlation of app-base tests in outdoor mode in the community, measured over pairs of outdoor tests performed by the same patient no more than 7 days apart.

Group	Value	95% CI
6MWT App Group	0.91

Compliance to Monitoring Regime in the Community Secondary · At month 6

Percentage of patients who performed at least 1 app-based 6MWT in the community per month

Group	Value	95% CI
6MWT App Group	12

Sponsor's own description

Comparison of standard 6 minute walk test with 6 minute walk test smartphone app.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. App-Based Versus Standard Six-Minute Walk Test in Pulmonary Hypertension: Mixed Methods Study.
   Salvi D, Poffley E, Tarassenko L, Orchard E. · · 2021 · cited 28× · PMID 34096876 · DOI 10.2196/22748
2. Appraisal of digital home-based 6-Minute Walk Test for use in remote healthcare delivery.
   Varnfield M, Mahoney A. · · 2021 · cited 3× · PMID 36711181 · DOI 10.1093/ehjdh/ztab021