Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial

Henrik Hansen, Theresa Bieler, Nina Beyer, Thomas Kallemose, Jon Torgny Wilcke, Lisbeth Marie Østergaard, Helle Frost Andeassen, Gerd Martinez, Marie Lavesen, Anne Frølich, Nina Skavlan Godtfredsen, Henrik Hansen, Theresa Bieler, Nina Beyer, Thomas Kallemose, Jon Torgny Wilcke, Lisbeth Marie Østergaard, Helle Frost Andeassen, Gerd Martinez, Marie Lavesen, Anne Frølich, Nina Skavlan Godtfredsen

Abstract

Rationale: Pulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR).

Objective: To investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV1 <50% eligible for routine hospital-based, outpatient PR.

Methods: In this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60 min, three times weekly) or conventional PR (90 min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks' follow-up from baseline. The primary analysis was based on the intention-to-treat principle.

Measurements and main results: The primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD age 68±9 years, FEV1 33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95% CI: -6.6 to 24.9)) or at 22 weeks' follow-up (-5.3 metres (95% CI: -28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (χ2 test p<0.01).

Conclusion: PTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design. Trial registration number ClinicalTrials.gov (NCT02667171), 28 January 2016.

Keywords: exercise; pulmonary rehabilitation.

Conflict of interest statement

Competing interests: HH received personal grants from the Danish Lung Foundation (charitable funding), Telemedical Center Regional Capital Copenhagen (governmental funding), TrygFonden foundation (charitable funding). The grants cover expenses conducting the trial, salary and university fee for the PhD education. TB, NB, TK, TW, LØ, HFA, GM, ML, AF and NG have nothing to disclose.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials diagram. AMA, Amager; BBH, Bispebjerg; Disc, discogenic issue; FBH, Frederiksberg; FSH, Frederikssund; GEH, Gentofte; HEH, Herlev; HIL, Hillerød; HVH, Hvidovre; MI, myocardial infarction; OA, osteoarthritis; PR, pulmonary rehabilitation; PTR, pulmonary tele-rehabilitation, RCT, randomised controlled trial.

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