Hypertension, Pulmonary
Conditions
Keywords
health related quality of life, anxiety, depression, coping, fatigue
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.
Interventions
DEVICEPedometer
A pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74.
Performed according to current recommendations during routine visits (baseline and \ 90 days for the purposes of this study).
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
In this first study, the links between variables and discordance between walking test and pedometer results will be searched.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The patient's discordance category as precisely defined here: | 74 days | Linear regression is performed for the distance walked during an initial 6 minute walking test (6MWT) and the average distance walked per day according to the pedometer intervention. The residuals from this regression will determine categories: Category 1 (pedometer high): the 25% of subjects not in category 2 and with higher values for pedometer data Category 2 (concordance): the 50% of included subjects with the smallest residuals in terms of absolute value. Category 3 (6MWT high): the 25% of subjects not in category 2 and with higher values for 6MWT data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36)) | Day 0 | This scale evaluates social, emotional and physical health of the patient through 11 questions. |
| Hospital Anxiety and Depression (HAD) scale | Day 0 | It is a questionnaire which detects if the patient is anxious or depressed through 14 questions. |
| State-Trait Anxiety Inventory (STAI) questionnaire | Day 0 | The State-Trait Anxiety Inventory is a 20 question-scale. For each question 4 levels of response are possible from 1 (never) to 4 (always). |
| Multidimensional Fatigue Inventory (MFI)-20 questionnaire | Day 0 | This questionnaire assesses the severity of the patient fatigue through 20 questions. For each question, 4 levels of response are possible : from not at all to completely. |
| Coping with Health Injuries and Problems Scale | Day 0 | This questionnaire assesses how the patient responds to health injuries and problems with 32 questions. For each question 5 levels of response are possible from 1 (not at all) to 5 (always). |
Countries
France
Contacts
Primary ContactLaurence Halimi, PhD, psychologist
Outcome results
None listed