Pedometers and Walking Tests for Pulmonary Hypertension Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03810482
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Montpellier
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Arnaud Bourdin, MD, PhD
Principal Investigator Affiliation	University Hospitals of Monpellier
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hypertension, Pulmonary

Additional Details

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.

Arms & Interventions

Arms

Experimental: The study population

The study population as described by eligibility criteria. Intervention: 6 minute walking test Intervention: pedometer

Interventions

Device: - Pedometer

A pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74.

Other: - 6 minute walking test

Performed according to current recommendations during routine visits (baseline and ~90 days for the purposes of this study).

Contact a Trial Team

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