Pedometers and Walking Tests for Pulmonary Hypertension Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pedometers and Walking Tests for Pulmonary Hypertension Patients: a First, Prospective Psychology and Concordance Study

Conditions
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Hypertension, Pulmonary

Intervention / Treatment
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* Device: Pedometer
* Other: 6 minute walking test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: In this first study, the links between variables and discordance between walking test and pedometer results will be searched.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The study population<br>The study population as described by eligibility criteria. Intervention: 6 minute walking test Intervention: pedometer | Device: Pedometer<br>* A pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74.<br>Other: 6 minute walking test<br>* Performed according to current recommendations during routine visits (baseline and  90 days for the purposes of this study).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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)) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health related quality of life, anxiety, depression, coping, fatigue