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Pedometers and Walking Tests for Pulmonary Hypertension Patients (HTAPODO)

Primary Purpose

Hypertension, Pulmonary

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pedometer
6 minute walking test
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension, Pulmonary focused on measuring health related quality of life, anxiety, depression, coping, fatigue

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arnaud de Villeneuve HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The study population

Arm Description

The study population as described by eligibility criteria. Intervention: 6 minute walking test Intervention: pedometer

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Hospital Anxiety and Depression (HAD) scale
It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.
Hospital Anxiety and Depression (HAD) scale
It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.
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).
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).
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".
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".
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).
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).

Full Information

First Posted
January 17, 2019
Last Updated
September 7, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03810482
Brief Title
Pedometers and Walking Tests for Pulmonary Hypertension Patients
Acronym
HTAPODO
Official Title
Pedometers and Walking Tests for Pulmonary Hypertension Patients: a First, Prospective Psychology and Concordance Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
June 21, 2024 (Anticipated)
Study Completion Date
June 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
Keywords
health related quality of life, anxiety, depression, coping, fatigue

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The study population
Arm Type
Experimental
Arm Description
The study population as described by eligibility criteria. Intervention: 6 minute walking test Intervention: pedometer
Intervention Type
Device
Intervention Name(s)
Pedometer
Intervention Description
A pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74.
Intervention Type
Other
Intervention Name(s)
6 minute walking test
Intervention Description
Performed according to current recommendations during routine visits (baseline and ~90 days for the purposes of this study).
Primary Outcome Measure Information:
Title
The patient's discordance category as precisely defined here:
Description
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
Time Frame
74 days
Secondary Outcome Measure Information:
Title
Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))
Description
This scale evaluates social, emotional and physical health of the patient through 11 questions.
Time Frame
Day 0
Title
Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))
Description
This scale evaluates social, emotional and physical health of the patient through 11 questions.
Time Frame
Month 3
Title
Hospital Anxiety and Depression (HAD) scale
Description
It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.
Time Frame
Day 0
Title
Hospital Anxiety and Depression (HAD) scale
Description
It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.
Time Frame
Month 3
Title
State-Trait Anxiety Inventory (STAI) questionnaire
Description
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).
Time Frame
Day 0
Title
State-Trait Anxiety Inventory (STAI) questionnaire
Description
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).
Time Frame
Month 3
Title
Multidimensional Fatigue Inventory (MFI)-20 questionnaire
Description
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".
Time Frame
Day 0
Title
Multidimensional Fatigue Inventory (MFI)-20 questionnaire
Description
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".
Time Frame
Month 3
Title
Coping with Health Injuries and Problems Scale
Description
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).
Time Frame
Day 0
Title
Coping with Health Injuries and Problems Scale
Description
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).
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence Halimi, PhD, psychologist
Phone
+33.(0)4.67.33.07.45
Email
l-halimi@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Bourdin, MD, PhD
Organizational Affiliation
University Hospitals of Monpellier
Official's Role
Study Director
Facility Information:
Facility Name
Arnaud de Villeneuve Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Bourdin, MD, PhD
First Name & Middle Initial & Last Name & Degree
Clement Boissin, MD
First Name & Middle Initial & Last Name & Degree
Anne Sophie Gamez, MD
First Name & Middle Initial & Last Name & Degree
Romain Jean, MD
First Name & Middle Initial & Last Name & Degree
Jérémy Charriot, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pedometers and Walking Tests for Pulmonary Hypertension Patients

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