Hypertension, PulmonaryHTAPODONCT03810482
Pedometers and Walking Tests for Pulmonary Hypertension Patients
A study testing Pedometer and 6 minute walking test in people with Hypertension, Pulmonary, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Pedometer and 6 minute walking test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2019to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Arnaud de Villeneuve Hospital
Montpellier, 34295
Arnaud Bourdin, MD, PhD
Clement Boissin, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Pedometer, 6 minute walking test
- Keywords
- health related quality of life, anxiety, depression, coping, fatigue
- Medical subject headings
- Hypertension, Pulmonary, Anxiety Disorders, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PedometerDevice
A pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74.
6 minute walking testOther
Performed according to current recommendations during routine visits (baseline and ~90 days for the purposes of this study).
| Study group | Role | What they receive |
|---|---|---|
| The study population | Experimental | The study population as described by eligibility criteria.
Intervention: 6 minute walking test Intervention: pedometer Receives: Device: Pedometer; Other: 6 minute walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 74 days
Secondary outcomes (10)
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.
Measured: Day 0
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.
Measured: Month 3
Hospital Anxiety and Depression (HAD) scale
It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.
Measured: Day 0
Hospital Anxiety and Depression (HAD) scale
It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.
Measured: Month 3
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).
Measured: Day 0
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).
Measured: Month 3
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".
Measured: Day 0
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".
Measured: Month 3
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).
Measured: Day 0
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).
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start21 Mar 2019
- Primary completion21 Jun 2024 (estimated)
- Study completion21 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Bourdin, MD, PhD, Study director, University Hospitals of Monpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810482
- Sponsor's protocol ID
- RECHMPL18_0186
- Acronym
- HTAPODO
- Status last verified
- Sep 2023
- First submitted
- 17 Jan 2019
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pedometers and Walking Tests for Pulmonary Hypertension Patients: a First, Prospective Psychology and Concordance Study
- ClinicalTrials.gov ID
- NCT03810482
- Acronym / sponsor ID
- HTAPODO / RECHMPL18_0186
- Conditions
- Hypertension, Pulmonary
- Keywords
- health related quality of life, anxiety, depression, coping, fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 21 Jun 2024 (estimated)
- Study completion
- 21 Jun 2024 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this first study, the links between variables and discordance between walking test and pedometer results will be searched.
| Arm | Type | Receives |
|---|---|---|
| The study population | Experimental | Device: Pedometer, Other: 6 minute walking testThe study population as described by eligibility criteria. Intervention: 6 minute walking test Intervention: pedometer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PedometerA pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74. | Device | The study population |
| 6 minute walking testPerformed according to current recommendations during routine visits (baseline and ~90 days for the purposes of this study). | Other | The study population |
Primary outcome
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
10 secondary outcomes
Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))
Time frame: Day 0
Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))
Time frame: Month 3
Hospital Anxiety and Depression (HAD) scale
Time frame: Day 0
Hospital Anxiety and Depression (HAD) scale
Time frame: Month 3
State-Trait Anxiety Inventory (STAI) questionnaire
Time frame: Day 0
State-Trait Anxiety Inventory (STAI) questionnaire
Time frame: Month 3
Multidimensional Fatigue Inventory (MFI)-20 questionnaire
Time frame: Day 0
Multidimensional Fatigue Inventory (MFI)-20 questionnaire
Time frame: Month 3
Coping with Health Injuries and Problems Scale
Time frame: Day 0
Coping with Health Injuries and Problems Scale
Time frame: Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Bourdin, MD, PhD study director
University Hospitals of Monpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer and 6 minute walking test in people with Hypertension, Pulmonary, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence Halimi, PhD, psychologist (+33.(0)4.67.33.07.45, l-halimi@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient's discordance category as precisely defined here: (time frame: 74 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.