Clinical trial NCT03810482: Pedometers and Walking Tests for Pulmonary Hypertension Patients
Official title: Pedometers and Walking Tests for Pulmonary Hypertension Patients: a First, Prospective Psychology and Concordance Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension, Pulmonary
Keywords: health related quality of life
anxiety
depression
coping
fatigue
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this first study, the links between variables and discordance between walking test and pedometer results will be searched.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility 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

Primary outcomes:
measure: The patient's discordance category as precisely defined here:
timeFrame: 74 days
Secondary outcomes:
measure: Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))
timeFrame: Day 0
measure: Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))
timeFrame: Month 3
measure: Hospital Anxiety and Depression (HAD) scale
timeFrame: Day 0
measure: Hospital Anxiety and Depression (HAD) scale
timeFrame: Month 3
measure: State-Trait Anxiety Inventory (STAI) questionnaire
timeFrame: Day 0
measure: State-Trait Anxiety Inventory (STAI) questionnaire
timeFrame: Month 3
measure: Multidimensional Fatigue Inventory (MFI)-20 questionnaire
timeFrame: Day 0
measure: Multidimensional Fatigue Inventory (MFI)-20 questionnaire
timeFrame: Month 3
measure: Coping with Health Injuries and Problems Scale
timeFrame: Day 0
measure: Coping with Health Injuries and Problems Scale
timeFrame: Month 3
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Arnaud de Villeneuve Hospital
Study officials:
affiliation: University Hospitals of Monpellier
name: Arnaud Bourdin, MD, PhD
role: STUDY_DIRECTOR
References: