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Pedometers and Walking Tests for Pulmonary Hypertension Patients (HTAPODO)

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ClinicalTrials.gov Identifier: NCT03810482
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Device: Pedometer Other: 6 minute walking test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Pedometers and Walking Tests for Pulmonary Hypertension Patients: a First, Prospective Psychology and Concordance Study
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : June 21, 2021
Estimated Study Completion Date : June 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The study population

The study population as described by eligibility criteria.

Intervention: 6 minute walking test Intervention: pedometer

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).




Primary Outcome Measures :
  1. The patient's discordance category as precisely defined here: [ Time Frame: 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 Outcome Measures :
  1. Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36)) [ Time Frame: Day 0 ]
    This scale evaluates social, emotional and physical health of the patient through 11 questions.

  2. Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36)) [ Time Frame: Month 3 ]
    This scale evaluates social, emotional and physical health of the patient through 11 questions.

  3. Hospital Anxiety and Depression (HAD) scale [ Time Frame: Day 0 ]
    It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.

  4. Hospital Anxiety and Depression (HAD) scale [ Time Frame: Month 3 ]
    It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.

  5. State-Trait Anxiety Inventory (STAI) questionnaire [ Time Frame: 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).

  6. State-Trait Anxiety Inventory (STAI) questionnaire [ Time Frame: Month 3 ]
    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).

  7. Multidimensional Fatigue Inventory (MFI)-20 questionnaire [ Time Frame: 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".

  8. Multidimensional Fatigue Inventory (MFI)-20 questionnaire [ Time Frame: Month 3 ]
    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".

  9. Coping with Health Injuries and Problems Scale [ Time Frame: 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).

  10. Coping with Health Injuries and Problems Scale [ Time Frame: Month 3 ]
    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).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810482


Contacts
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Contact: Laurence Halimi, PhD, psychologist +33.(0)4.67.33.07.45 l-halimi@chu-montpellier.fr

Locations
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France
Arnaud de Villeneuve Hospital Recruiting
Montpellier, France, 34295
Principal Investigator: Arnaud Bourdin, MD, PhD         
Sub-Investigator: Clement Boissin, MD         
Sub-Investigator: Anne Sophie Gamez, MD         
Sub-Investigator: Romain Jean, MD         
Sub-Investigator: Jérémy Charriot, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Arnaud Bourdin, MD, PhD University Hospitals of Monpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03810482     History of Changes
Other Study ID Numbers: 7652
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
health related quality of life
anxiety
depression
coping
fatigue

Additional relevant MeSH terms:
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Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases