Pedometers and Walking Tests for Pulmonary Hypertension Patients

Hypertension, Pulmonary Clinical Trial

— HTAPODO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03810482
• Other study ID #: RECHMPL18_0186
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2019
• Est. completion date: June 21, 2024

Study information

• Verified date: September 2023
• Source: University Hospital, Montpellier
• Contact: Laurence Halimi, PhD, psychologist
• Phone: +33.(0)4.67.33.07.45
• Email: l-halimi[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 21, 2024
• Est. primary completion date: June 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

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).

Locations

Country	Name	City	State
France	Arnaud de Villeneuve Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Hospital Anxiety and Depression (HAD) scale	It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.	Day 0
Secondary	Hospital Anxiety and Depression (HAD) scale	It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.	Month 3
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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