A pilot study of a digital 1-Minute Walk Test as a novel decentralised endpoint in pulmonary hypertension research

Background

The 6-Minute Walk Test (6MWT) is an established endpoint in pulmonary hypertension trials. Shorter and digital formats could prove advantageous in decentralised and patient-centred trials.

Aims

To evaluate the agreement of shorter duration walk tests with the 6MWT.

To compare a novel digital 1MWT with the gold-standard 6MWT via multiple quantitative/qualitative metrics.

Methods

The distance walked at each minute of the 6MWT was compared. Patients completed the 6MWT and a 1MWT via a wearable device (Garmin Venu 2) paired to an app (Atom5^TM) co-designed and beta-tested with patients.

Results

There is a significant strong and positive correlation between the distance walked during shorter epochs and the total 6MWD (Figure 1). The 1MWT and 6MWT confer equivalent prognostic value and correlation with established variables. Initial pilot data shows that the digital 1MWT correlates strongly with the gold-standard 6MWT (Figure 2). Qualitatively, patients prefer shorter and remote testing.

Conclusions

The digital 1MWD has technical accuracy and patient acceptability. It is a potential decentralised endpoint in future trials.