In-Patient Pulmonary Rehabilitation to Improve Asthma Control–A Randomized Controlled Study (EPRA, Effectiveness of Pulmonary Rehabilitation for Patients with Asthma)

Abstract

Background: Despite the availability of effective pharmaceutical treatment options, many patients with asthma do not manage to control their illness. This randomized trial with a waiting-list control group examined whether a 3-week course of inpatient pulmonary rehabilitation (PR) improves asthma control (primary endpoint) and other secondary endpoints (e.g., quality of life, cardinal symptoms, mental stress). The subsequent observational segment of the study investigated the long-term outcome after PR.

Methods: After approval of the rehabilitation´ by the insurance providers (T0), 412 adults with uncontrolled asthma (Asthma Control Test [ACT] score < 20 points) undergoing rehabilitation were assigned to either the intervention group (IG) or the waiting-list control group (CG). PR commenced 1 month (T1) after randomization in the IG and 5 months after randomization (T3) in the CG. Asthma control and the secondary endpoints were assessed 3 months after PR in the IG (T3) as an intention-to-treat analysis by means of analyses of covariance. Moreover, both groups were observed for a period of 12 months after the end of PR.

Results: At T3 the mean ACT score was 15.76 points in the CG, 20.38 points in the IG. The adjusted mean difference of 4.71 points was clinically relevant (95% confidence interval [3.99; 5.43]; effect size, Cohen's d = 1.27). The secondary endpoints also showed clinically relevant effects in favor of the IG. A year after the end of rehabilitation the mean ACT score was 19.00 points, still clinically relevant at 3.54 points higher than when rehabilitation began. Secondary endpoints such as quality of life and cardinal symptoms (dyspnea, cough, expectoration, pain) and self-management showed moderate to large effects.

Conclusion: The trial showed that a 3-week course of PR leads to clinically relevant improvement in asthma control and secondary endpoints. Patients who do not achieve control of their asthma despite outpatient treatment therefore benefit from rehabilitation.

Figure 1

Trial profile: CONSORT (Consolidated Standards of Reporting Trials) flowchart CG, control group; IG, intervention group; T0, time at randomization; T1/T2/T3, 1/3/5 months after randomization

Figure 2

a) Randomized controlled trial (RCT; effects between IG and CG): Mean values and 95% confidence intervals of the primary endpoint Asthma Control Test (ACT) from T0 to T3. ACT scores ≥ 20 indicate well-controlled asthma, ACT scores of 5–19 indicate poorly controlled asthma. b) Pooled cohort observational study (follow-up of the EPRA trial): Mean values and 95% confidence intervals of the ACT scores for the IG and the CG at T0 and at the start (S) and end (E) of rehabilitation. The interval from T0 to start of rehabilitation was 1 month for the IG, and 5 months for the CG. T0, study inclusion/randomization; T1, start of rehab. for intervention group (IG) = 4 weeks after T0; T2, end of rehab. for IG; T3, 3 months after end of rehab. for IG, and start of rehab. for the control group (CG), who had been on the waiting list (with usual care) prior to T3

eFigure

Study design: The EPRA (Effectiveness of Pulmonary Rehabilitation for Patients with Asthma) study combines a randomized control group study with a waiting-list group design (T0 to T3; T0, study inclusion/ randomization; T1, start of rehabilitation for intervention group [IG]; T2, end of rehabilitation for IG; T3, 3 months after the end of rehabilitation for IG, or start of rehabilitation for the control group [CG]), with a subsequent pooled observational study (follow-up of both study groups for up to 12 months after end of rehabilitation).