Pedometers and Walking Tests for Pulmonary Hypertension Patients

Not Applicable

Recruiting

• Conditions: Hypertension, Pulmonary

• Registration Number: NCT03810482
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Study Start: 2019-03-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08
• Primary Completion: 2024-06-21
• Study Completion: 2024-06-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The patient's discordance category as precisely defined here:	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

Name	Time	Method
Coping with Health Injuries and Problems Scale	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).
Multidimensional Fatigue Inventory (MFI)-20 questionnaire	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".
Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))	Month 3	This scale evaluates social, emotional and physical health of the patient through 11 questions.
Hospital Anxiety and Depression (HAD) scale	Month 3	It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.
State-Trait Anxiety Inventory (STAI) questionnaire	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).

Trial Locations

Locations (1)

Arnaud de Villeneuve Hospital; 🇫🇷 Montpellier, France