Pedometers and Walking Tests for Pulmonary Hypertension Patients (HTAPODO)

University Hospital Center (CHU)

Status

Enrolling

Conditions

Hypertension, Pulmonary

Treatments

Other: 6 minute walking test

Device: Pedometer

Study type

Interventional

Funder types

Other

Identifiers

NCT03810482

RECHMPL18_0186

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with idiopathic pulmonary hypertension (PH), familial PH, or PH associated with various pathologies (groups I to IV of the international classification)
New York Heart Association (NYHA) severity classes II to IV
Incident cases, or prevalent cases with stable disease over the last 3 months
Collection of informed written consent
Affiliation with or beneficiary of a social security program (health insurance)
Outpatient consulting at the hospital on the day of inclusion
6 minute walking test on day of inclusion

Exclusion criteria

Patients protected or unable to give consent according to Article L1121-8 of the French Public Health Code (CSP)
Pregnant or lactating women according to article L1121-5 of the CSP
Vulnerable persons according to article L1121-6 of the CSP
Simultaneous participation in any other research protocol
It is impossible to correctly inform the patient (language barrier, etc.)
The patient has already been included in the study