- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03810482
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
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
-
-
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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
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Sub-Investigator:
- Jérémy Charriot, MD
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Sub-Investigator:
- Clément BOISSIN, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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 |
A pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74.
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:
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 |
74 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 0
|
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.
|
Month 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.
|
Day 0
|
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.
|
Month 3
|
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).
|
Day 0
|
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).
|
Month 3
|
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".
|
Day 0
|
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".
|
Month 3
|
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).
|
Day 0
|
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).
|
Month 3
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Arnaud Bourdin, MD, PhD, University Hospitals of Monpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL18_0186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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