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Randomized Controlled Trial
. 2017 Jan;72(1):57-65.
doi: 10.1136/thoraxjnl-2016-208514. Epub 2016 Sep 26.

Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial

Anne E Holland  1   2   3 , Ajay Mahal  4 , Catherine J Hill  3   5 , Annemarie L Lee  1   2   3 , Angela T Burge  1   2   3 , Narelle S Cox  1   3 , Rosemary Moore  3 , Caroline Nicolson  1   2 , Paul O'Halloran  6 , Aroub Lahham  1   3 , Rebecca Gillies  1   5 , Christine F McDonald  3   7   8
Affiliations
Randomized Controlled Trial

Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial

Anne E Holland et al. Thorax. 2017 Jan.

Abstract

Background: Pulmonary rehabilitation is a cornerstone of care for COPD but uptake of traditional centre-based programmes is poor. We assessed whether home-based pulmonary rehabilitation, delivered using minimal resources, had equivalent outcomes to centre-based pulmonary rehabilitation.

Methods: A randomised controlled equivalence trial with 12 months follow-up. Participants with stable COPD were randomly assigned to receive 8 weeks of pulmonary rehabilitation by either the standard outpatient centre-based model, or a new home-based model including one home visit and seven once-weekly telephone calls from a physiotherapist. The primary outcome was change in 6 min walk distance (6MWD).

Results: We enrolled 166 participants to receive centre-based rehabilitation (n=86) or home-based rehabilitation (n=80). Intention-to-treat analysis confirmed non-inferiority of home-based rehabilitation for 6MWD at end-rehabilitation and the confidence interval (CI) did not rule out superiority (mean difference favouring home group 18.6 m, 95% CI -3.3 to 40.7). At 12 months the CI did not exclude inferiority (-5.1 m, -29.2 to 18.9). Between-group differences for dyspnoea-related quality of life did not rule out superiority of home-based rehabilitation at programme completion (1.6 points, -0.3 to 3.5) and groups were equivalent at 12 months (0.05 points, -2.0 to 2.1). The per-protocol analysis showed the same pattern of findings. Neither group maintained postrehabilitation gains at 12 months.

Conclusions: This home-based pulmonary rehabilitation model, delivered with minimal resources, produced short-term clinical outcomes that were equivalent to centre-based pulmonary rehabilitation. Neither model was effective in maintaining gains at 12 months. Home-based pulmonary rehabilitation could be considered for people with COPD who cannot access centre-based pulmonary rehabilitation.

Trial registration number: NCT01423227, clinicaltrials.gov.

Keywords: Pulmonary Rehabilitation.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow of participants through the trial. 6MWT, 6 min walk test; PR, pulmonary rehabilitation. AECOPD; acute exacerbation of chronic obstructive pulmonary disease.
Figure 2
Figure 2
Difference between groups for 6 min walk distance (6MWD) and equivalence limits. PR, pulmonary rehabilitation. Data are mean and 95% CI for difference between groups. Shaded area represents equivalence limits, which are ±minimal important difference.
Figure 3
Figure 3
Difference between groups for Chronic Respiratory Disease Questionnaire (CRQ) dyspnoea domain and equivalence limits. PR, pulmonary rehabilitation. Data are mean and 95% CI for difference between groups. Shaded area represents equivalence limits, which are ±minimal important difference.
Figure 4
Figure 4
Difference between groups for 6 min walk distance (6MWD) and equivalence limits, per protocol analysis. PR, pulmonary rehabilitation. Data are mean and 95% CI for difference between groups. Shaded area represents equivalence limits, which are ±minimal important difference.
Figure 5
Figure 5
Time to first hospitalisation for (A) all admissions and (B) admissions with a respiratory cause. p Value is for difference between groups on log-rank test.
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References

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