Pedometers and Walking Tests for Pulmonary Hypertension Patients (HTAPODO)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03810482 |
Recruitment Status :
Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : February 4, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension, Pulmonary | Device: Pedometer Other: 6 minute walking test | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Intervention Model: | Single Group Assignment |
Intervention 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) |
Primary Purpose: | Diagnostic |
Official Title: | Pedometers and Walking Tests for Pulmonary Hypertension Patients: a First, Prospective Psychology and Concordance Study |
Estimated Study Start Date : | March 1, 2019 |
Estimated Primary Completion Date : | June 1, 2021 |
Estimated Study Completion Date : | June 1, 2021 |

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). |
- Highlighting 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
- Health relation 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.
- Health relation 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.
- 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.
- 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.
- State-Trait Anxiety Inventory (STAI) questionnaire [ Time Frame: Day 0 ]The State-Trait Anxiety Inventory is a 20 questions-scale. For each question 4 levels of response are possible from 1 (never) to 4 (always).
- State-Trait Anxiety Inventory (STAI) questionnaire [ Time Frame: Month 3 ]The State-Trait Anxiety Inventory is a 20 questions-scale. For each question 4 levels of response are possible from 1 (never) to 4 (always).
- 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".
- 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".
- 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).
- 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810482
Contact: Laurence Halimi, PhD, psychologist | +33.(0)4.67.33.07.45 | l-halimi@chu-montpellier.fr |
France | |
Arnaud de Villeneuve Hospital | Not yet recruiting |
Montpellier, France, 34295 | |
Principal Investigator: Arnaud Bourdin, MD, PhD | |
Sub-Investigator: Clement Boissin, MD | |
Sub-Investigator: Anne Sophie Gamez, MD | |
Sub-Investigator: Romain Jean, MD | |
Sub-Investigator: Jérémy Charriot, MD |
Study Director: | Arnaud Bourdin, MD, PhD | University Hospitals of Monpellier |
Responsible Party: | University Hospital, Montpellier |
ClinicalTrials.gov Identifier: | NCT03810482 History of Changes |
Other Study ID Numbers: |
7652 |
First Posted: | January 18, 2019 Key Record Dates |
Last Update Posted: | February 4, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by University Hospital, Montpellier:
health related quality of life anxiety depression coping fatigue |
Additional relevant MeSH terms:
Hypertension Hypertension, Pulmonary Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |