Using pedometers and walking tests to assess pulmonary hypertension patients
Pedometers and Walking Tests for Pulmonary Hypertension Patients: a First, Prospective Psychology and Concordance Study
NA · University Hospital, Montpellier · NCT03810482
This study is testing how the distance people with pulmonary hypertension walk in six minutes compares to their daily activity tracked by pedometers to see how these measures relate to their symptoms and overall health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT03810482 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between the distance walked during a 6-minute walking test and daily activity measured by pedometers in patients with pulmonary hypertension (PH). It will investigate the factors contributing to discrepancies between these two measures over a 28-day period. Additionally, the study will analyze the correlation between pedometer data and self-reported symptoms of dyspnea, as well as variables linked to progression-free survival. Factorial analysis may be employed to understand the overall patterns and similarities among patients.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with idiopathic pulmonary hypertension or related conditions, classified as NYHA severity classes II to IV.
Not a fit: Patients who are unable to provide informed consent or have severe language barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of physical activity levels in pulmonary hypertension patients, leading to improved management and quality of life.
How similar studies have performed: While the approach of using pedometers in conjunction with walking tests is not widely established, similar studies have shown promise in understanding patient activity levels.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier
- Arnaud de Villeneuve Hospital — Montpellier, France (RECRUITING)
Study contacts
- Study coordinator: Laurence Halimi, PhD, psychologist
- Email: l-halimi@chu-montpellier.fr
- Phone: +33.(0)4.67.33.07.45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Pulmonary, health related quality of life, anxiety, depression, coping, fatigue