Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 16, 2024
Open Peer Review Period: Feb 18, 2024 - Feb 26, 2024
Date Accepted: Mar 4, 2024
(closed for review but you can still tweet)
Assessing functional capacity in directly and remotely monitored home-based settings in individuals with chronic respiratory diseases: A protocol for a multinational validation study
ABSTRACT
Background:
Pulmonary rehabilitation is widely recommended to improve functional status and as secondary and tertiary prevention in individuals with chronic pulmonary diseases. Unfortunately, access to timely and appropriate rehabilitation services remains limited. To help close this inaccessibility gap, telerehabilitation models of care have been proposed. However, to ensure effective and safe exercise prescription during rehabilitation, exercise testing is necessary. Current gold standard tests, such as maximal cardiopulmonary exercise testing (CPET) and the 6-minute walk test (6MWT), are poorly adapted to home-based or telerehabilitation settings. This has been highlighted as an obstacle to the continuity of services during the COVID-19 pandemic. It is therefore essential to validate tests adapted to these new realities, such as the 6-minute stepper test (6MST).
Objective:
To evaluate the metrological qualities of 6MST by: (1) establishing concurrent validity and agreement between the 6MST and CPET, as well as with the 6MWT; (2) determining test-retest reliability in a home-based setting with direct and remote (videoconferencing) monitoring; and (3) documenting adverse events and participant perspectives when performing the 6MST in home-based settings.
Methods:
Three centers (CR-IUCPQ in Québec, and GHICL and FormAction Santé in France) will be involved in this multinational project which is divided into two studies. For study 1 (objective 1), 30 participants (Québec = 15, France = 15) will be recruited. Two laboratory visits will be performed for assessing anthropometric data, pulmonary function, and the three exercise tolerance tests (CPET, 6MWT, 6MST). Concurrent validity (paired sample t-tests and Pearson correlations) and agreement (Bland-Altman plots with 95% agreement limits) will be evaluated. For study 2 (objectives 2 and 3), 52 participants (Québec = 26, France = 26) will be recruited. Following a familiarization trial (trial 1), the 6MST will be conducted on two separate occasions (trials 2 and 3), once under direct supervision and once under remote supervision, in a randomized order. Paired sample t-test, Bland-Altman plots, and intraclass correlations will be used to compare trials 2 and 3. A semi-structured interview will be conducted after the third trial to collect participants’ perspectives.
Results:
Ethical approval was received for this project and the first participant was recruited in February 2024.
Conclusions:
This study innovates by being among the first to validate a new clinical test necessary for the development and implementation of new models of rehabilitation adapted to home and telerehabilitation contexts. This study also aligns with the United Nations Sustainable Development Goals by contributing to augmenting healthcare service delivery (goal 3) and reducing healthcare access inequalities (goal 11).
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.