Article Text
Abstract
Rationale Pulmonary rehabilitation is an effective treatment for people with chronic respiratory disease but is delivered to <5% of eligible individuals. This study investigated whether home-based telerehabilitation was equivalent to centre-based pulmonary rehabilitation in people with chronic respiratory disease.
Methods A multicentre randomised controlled trial with assessor blinding, powered for equivalence was undertaken. Individuals with a chronic respiratory disease referred to pulmonary rehabilitation at four participating sites (one rural) were eligible and randomised using concealed allocation to pulmonary rehabilitation or telerehabilitation. Both programmes were two times per week for 8 weeks. The primary outcome was change in Chronic Respiratory Disease Questionnaire Dyspnoea (CRQ-D) domain at end-rehabilitation, with a prespecified equivalence margin of 2.5 points. Follow-up was at 12 months. Secondary outcomes included exercise capacity, health-related quality of life, symptoms, self-efficacy and psychological well-being.
Results 142 participants were randomised to pulmonary rehabilitation or telerehabilitation with 96% and 97% included in the intention-to-treat analysis, respectively. There were no significant differences between groups for any outcome at either time point. Both groups achieved meaningful improvement in dyspnoea and exercise capacity at end-rehabilitation. However, we were unable to confirm equivalence of telerehabilitation for the primary outcome ΔCRQ-D at end-rehabilitation (mean difference (MD) (95% CI) −1 point (−3 to 1)), and inferiority of telerehabilitation could not be excluded at either time point (12-month follow-up: MD −1 point (95% CI −4 to 1)). At end-rehabilitation, telerehabilitation demonstrated equivalence for 6-minute walk distance (MD −6 m, 95% CI −26 to 15) with possibly superiority of telerehabilitation at 12 months (MD 14 m, 95% CI −10 to 38).
Conclusion telerehabilitation may not be equivalent to centre-based pulmonary rehabilitation for all outcomes, but is safe and achieves clinically meaningful benefits. When centre-based pulmonary rehabilitation is not available, telerehabilitation may provide an alternative programme model.
Trial registration number ACtelerehabilitationN12616000360415.
- pulmonary rehabilitation
- exercise
Data availability statement
Data are available upon reasonable request. Will individual participant data be available (including data dictionaries)? Yes. What data in particular will be shared? Individual participant data can be shared after de-identification and once approval has been obtained from the relevant Human Research Ethics Committee. What other documents will be available? Study protocol. When will data be available (start and end dates)? Data will be available indefinitely on a case by case basis, at the discretion of the coordinating principal investigator and relevant Human Research Ethics Committee. With whom? Data will be available on a case by case basis, at the discretion of the coordinating principal investigator and relevant Human Research Ethics Committee. For what types of analyses? Type of analysis data available for will be at the discretion of the relevant Human Research Ethics Committee. By what mechanism will data be made available? Data requests should, in the first instance, be addressed to Professor Anne Holland (anne.holland@monash.edu). Access to data will be subject to approval by the coordinating principal investigator and relevant Human Research Ethics Committee.
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Data availability statement
Data are available upon reasonable request. Will individual participant data be available (including data dictionaries)? Yes. What data in particular will be shared? Individual participant data can be shared after de-identification and once approval has been obtained from the relevant Human Research Ethics Committee. What other documents will be available? Study protocol. When will data be available (start and end dates)? Data will be available indefinitely on a case by case basis, at the discretion of the coordinating principal investigator and relevant Human Research Ethics Committee. With whom? Data will be available on a case by case basis, at the discretion of the coordinating principal investigator and relevant Human Research Ethics Committee. For what types of analyses? Type of analysis data available for will be at the discretion of the relevant Human Research Ethics Committee. By what mechanism will data be made available? Data requests should, in the first instance, be addressed to Professor Anne Holland (anne.holland@monash.edu). Access to data will be subject to approval by the coordinating principal investigator and relevant Human Research Ethics Committee.
Footnotes
Contributors Procured funding: AEH, CFM, JAA, AM, RW, PZ, PO’H, CJH. Conceptualisation and design: AEH, CFM, JAA, AM, RW, PZ, PO’H, CJH, NSC. Data acquisition: NSC, AEH, CJH, JB, KB, ATB, BW, CM, AL, HM, HC, PC, AN, HB, EH, MC. Data analysis: NSC, AEH, EH. Drafting manuscript: NSC, AEH. Critical review of manuscript: CFM, JAA, AM, RW, PZ, PO’H, CJH, JB, KB, ATB, BW, CM, AL, HM, HC, PC, AN, HB, EH, MC, AEH.
Funding Funding for this trial was from a competitive National Health and Medical Research Council (NHMRC) project grant (GNT 1101616). NSC is the holder of an NHMRC Early Career Fellowship (GNT 1119970).
Competing interests AEH, CFM, JAA, AM and RW, as the chief investigators, report grant funding from the National Health and Medical Research Council (NHMRC) (GNT1101616) for the conduct of this trial. NSC reports fellowship funding from the NHMRC (GNT1119970) to work on this trial. CFM reports fees paid to the institution from Menarini and AstraZeneca, and in-kind trial support from Air Liquide Healthcare—all unrelated to the present work.
Provenance and peer review Not commissioned; externally peer reviewed.
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