Pedometers and Walking Tests for Pulmonary Hypertension Patients (HTAPODO)

• ClinicalTrials.gov Identifier: NCT03810482
• Recruitment Status: Recruiting
• First Posted: January 18, 2019
• Last Update Posted: September 16, 2019
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Study Description

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.

Study Design

• 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

Arms and Interventions

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).

Outcome Measures

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).

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Study Director: Arnaud Bourdin, MD, PhD; University Hospitals of Monpellier

More Information

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT03810482 History of Changes
• Other Study ID Numbers: RECHMPL18_0186
• First Posted: January 18, 2019
• Last Update Posted: September 16, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Hypertension, Pulmonary; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases