An interventional study of Pedometer and 6 minute walking test in Hypertension, Pulmonary, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic
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.
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's planned enrollment of 70 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The study population as described by eligibility criteria. Intervention: 6 minute walking test Intervention: pedometer
Device: Pedometer · Other: 6 minute walking test
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).
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
Time frame: 74 days
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.
Time frame: 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.
Time frame: Month 3
Hospital Anxiety and Depression (HAD) scale
It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.
Time frame: Day 0
Hospital Anxiety and Depression (HAD) scale
It is a questionnaire which detects if the patient is anxious or depressed through 14 questions.
Time frame: 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).
Time frame: 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).
Time frame: 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".
Time frame: 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".
Time frame: 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).
Time frame: 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).
Time frame: Month 3
Plan to share: No
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University Hospital, Montpellier