Pedometers and Walking Tests for Pulmonary Hypertension Patients (HTAPODO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Device: Pedometer; Other: 6 minute walking test

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurence Halimi, PhD, psychologist; Phone Number: +33.(0)4.67.33.07.45; Email: l-halimi@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Arnaud de Villeneuve Hospital
    • Principal Investigator: Arnaud Bourdin, MD, PhD
    • Sub-Investigator: Anne Sophie Gamez, MD
    • Sub-Investigator: Romain Jean, MD
    • Sub-Investigator: Jérémy CHARRIOT, MD
    • Sub-Investigator: Clément BOISSIN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Arnaud Bourdin, MD, PhD, University Hospitals of Monpellier

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Estimated): June 21, 2024
• Study Completion (Estimated): June 21, 2024

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: fatigue; depression; anxiety; coping; health related quality of life
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: RECHMPL18_0186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No