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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | Experimental | The study population as described by eligibility criteria. Intervention: 6 minute walking test Intervention: pedometer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pedometer | Device | A pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The patient's discordance category as precisely defined here: | 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 | 74 days |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36)) | This scale evaluates social, emotional and physical health of the patient through 11 questions. | Day 0 |
| Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurence Halimi, PhD, psychologist | Contact | +33.(0)4.67.33.07.45 | l-halimi@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Arnaud Bourdin, MD, PhD | University Hospitals of Monpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arnaud de Villeneuve Hospital | Recruiting | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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In this first study, the links between variables and discordance between walking test and pedometer results will be searched.
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| 6 minute walking test | Other | Performed according to current recommendations during routine visits (baseline and ~90 days for the purposes of this study). |
|
This scale evaluates social, emotional and physical health of the patient through 11 questions. |
| Month 3 |
| Hospital Anxiety and Depression (HAD) scale | It is a questionnaire which detects if the patient is anxious or depressed through 14 questions. | Day 0 |
| Hospital Anxiety and Depression (HAD) scale | It is a questionnaire which detects if the patient is anxious or depressed through 14 questions. | Month 3 |
| State-Trait Anxiety Inventory (STAI) questionnaire | 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). | Day 0 |
| State-Trait Anxiety Inventory (STAI) questionnaire | 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). | Month 3 |
| Multidimensional Fatigue Inventory (MFI)-20 questionnaire | 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". | Day 0 |
| Multidimensional Fatigue Inventory (MFI)-20 questionnaire | 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". | Month 3 |
| Coping with Health Injuries and Problems Scale | 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). | Day 0 |
| Coping with Health Injuries and Problems Scale | 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). | Month 3 |
| D002318 |
| Cardiovascular Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |