Clinical Trials Directory

Trials / Unknown

UnknownNCT03810482

Pedometers and Walking Tests for Pulmonary Hypertension Patients

Pedometers and Walking Tests for Pulmonary Hypertension Patients: a First, Prospective Psychology and Concordance Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

Concordance between walking tests and pedometer data may seem like a logical outcome for pulmonary hypertension (PH) patients. However, many individuals have discordant results: results much worse or better during an in-hospital walking test as compared to real life activity. The primary objective of this study is: to determine variables associated with discordance between the distance walked during an in-hospital 6-minute walking test (6MWT) and the average distance travelled per day (observed over a period of 28 days (2 × 14 days) using a pedometer) among PH patients.

Detailed description

Secondarily, the discordance between 6MWT results versus total pedometer recorded distance and versus maximum daily pedometer-recorded distance will be similarly studied. The aim of the study is also to search for variables associated with progression free survival. The relationships between pedometer data and self-reported dyspnea variation will be studied. Factorial analysis may be used to study the overall view of variable correlations and patient similarity/dissimilarity.

Conditions

Interventions

TypeNameDescription
DEVICEPedometerA pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74.
OTHER6 minute walking testPerformed according to current recommendations during routine visits (baseline and \~90 days for the purposes of this study).

Timeline

Start date
2019-03-21
Primary completion
2024-06-21
Completion
2024-06-21
First posted
2019-01-18
Last updated
2023-09-08

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03810482. Inclusion in this directory is not an endorsement.