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| Name | Class |
|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | OTHER |
| Groupement des Hôpitaux de l'Institut Catholique de Lille | OTHER |
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The goal of this validation study is to provide further evidence of the metrological properties of the 6-minute stepper test in individuals with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).
The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lab testing (study 1) | Two 3-hour laboratory visits (separated by 6 to 18 days) will be conducted. During the first laboratory visit, anthropometric measurements, pulmonary function tests and CPET on a cycle ergometer will be performed. During the second laboratory visit, spirometry will be repeated to ensure stability of the participants health state (particularly relevant for individuals with COPD). Thereafter, the 6MST and 6MWT will be performed in a randomized order, separated by a rest period of at least 30 minutes. | ||
| At home testing (study 2) | Three 1-hour home visits (separated by 2 to 5 days) will be conducted. The first trial of the 6MST (familiarization trial) will be conducted at the participant's home with the therapist present. The second and third trials of the 6MST will be performed in a randomized order, with either direct (therapist present at the home) or remote (therapist present through videoconferencing software, as in a telerehabilitation setting) monitoring. |
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| Measure | Description | Time Frame |
|---|---|---|
| Concurrent validity | Assessed using paired sample t-tests (or Wilcoxon signed-rank tests) to verify whether peak cardiorespiratory (e.g., oxygen consumption, minute ventilation, heart rate, etc.) and symptomology (i.e., dyspnea and leg fatigue) values obtained during the 6-minute stepper test are comparable to the maximal cardiopulmonary test and the 6-minute walk test | Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days) |
| Strength of association between peak cardiorespiratory and symptomology values | Pearson's correlation coefficients (r) will be calculated between the number of steps taken during the 6-minute stepper test and peak oxygen consumption and heart rate reached during all three tests | Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days) |
| Agreement | Assessed with Bland-Altman plots and 95% limits of agreement (mean difference ± 1.96 standard deviation of the difference) between peak cardiorespiratory and symptomology values reached during the 6-minute stepper test and those reached during the maximal cardiopulmonary test and the 6-minute walk test | Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days) |
| Test-restest reliability | Reliability (trial 2 versus 3 = directly versus remotely monitored) will be assessed using paired sample t-tests (or Wilcoxon signed-rank tests), Bland-Altman plots (with 95% limits of agreement), and intraclass correlations | Study 2 - Trial 2 and 3 (separated by 2 to 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | All minor and serious adverse events, for all trials, will be reported | Through study completion, an average of 2 years |
| Level of comfort during test and perception of safety (qualitative) |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with chronic obstructive pulmonary disease or interstitial lung disease followed in outpatient hospital settings
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alec Bass, PT, PhD | Contact | 418-656-8711 | 3012 | alec.bass@criucpq.ulaval.ca |
| Marianne Belley | Contact | 418-656-8711 | 5882 | marianne.belley@criucpq.ulaval.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval | Recruiting | Québec | G1V 4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38941132 | Derived | Bass A, Gephine S, Martin M, Belley M, Robic M, Fabre C, Grosbois JM, Dion G, Saey D, Chambellan A, Maltais F. Assessing Functional Capacity in Directly and Remotely Monitored Home-Based Settings in Individuals With Chronic Respiratory Diseases: Protocol for a Multinational Validation Study. JMIR Res Protoc. 2024 Jun 28;13:e57404. doi: 10.2196/57404. |
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Assessed with thematic content analysis of semi-structured interviews (voice-recorded and transcribed)
| Study 2 - Trial 3 (semi-structured interview of 20 to 30 minutes following the completion of the last trial of the 6MST) |
| Groupement des Hôpitaux de l'Institut Catholique de Lille | Recruiting | Lille | Hauts-de-France | 59000 | France |
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| FormAction Santé | Not yet recruiting | Pérenchies | Hauts-de-France | 59840 | France |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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