Between-group difference in primary and secondary outcomes at 7 weeks postrandomisation follow-up—complete case analysis
| Home based Mean (SD) N | Centre based Mean (SD) N | Between-group difference (home centre)* Mean difference (95% CI) p value | Inference regarding non-inferiority | |
| CRQ-SR dyspnoea mITT PP | 3.15 (1.26) 79 3.01 (1.22) 62 | 3.38 (1.20) 83 3.38 (1.22) 70 | −0.24 (−0.61 to 0.12) 0.18 −0.38 (−0.79 to 0.02) 0.06 | Inconclusive Inconclusive |
| CRQ-SR fatigue mITT PP | 3.71 (1.21) 82 3.78 (1.22) 65 | 4.12 (1.49) 83 4.12 (1.56) 70 | −0.40 (−0.73 to 0.07) 0.02 −0.36 (−0.73 to 0.02) 0.06 | Inconclusive Inconclusive |
| CRQ-SR emotion mITT PP | 4.55 (1.20) 82 4.57 (1.23) 65 | 4.91 (1.06) 81 4.83 (1.06) 68 | −0.45 (−0.75 to 0.16) 0.01 −0.44 (−0.78 to −0.11) 0.01 | Inconclusive Inconclusive |
| CRQ-SR mastery mITT PP | 4.78 (1.30) 82 4.78 (1.28) 65 | 4.97 (1.21) 82 4.83 (1.06) 68 | −0.36 (−0.66 to 0.07) 0.02 −0.31 (−0.64 to 0.01) 0.06 | Inconclusive Inconclusive |
| HADS anxiety mITT PP | 7.15 (4.05) 81 6.83 (3.93) 64 | 6.74 (3.76) 86 6.92 (3.53) 71 | 0.73 (0.17 to 1.63) 0.11 0.57 (−0.40 to 1.54) 0.25 | Inconclusive Inconclusive |
| HADS depression mITT PP | 6.07 (3.68) 82 5.91 (3.67) 64 | 5.49 (3.16) 86 5.45 (3.20) 71 | 0.84 (0.04 to 1.63) 0.04 0.94 (0.07 to 1.81) 0.04 | Inconclusive Inconclusive |
| PRAISE mITT PP | 44.72 (8.50) 81 45.28 (8.62) 65 | 47.08 (7.72) 84 47.57 (7.09) 69 | −2.58 (−4.87 to −0.30) 0.03 −2.44 (−4.90 to 0.02) 0.05 | No non-inferiority margin No non-inferiority margin |
| ISWT distance (m) mITT PP | 281.18 (147.92) 85 288.18 (148.76) 66 | 309.53 (156.43) 85 311.27 (165.81) 71 | −23.56 (−45.30 to −1.81) 0.03 −19.87 (−44.39 to 4.65) 0.11 | Non-inferior Non-inferior |
| ESWT time (s) mITT PP | 442.00 (391.34) 85 468.53 (410.27) 66 | 545.98 (408.58) 82 541.50 (417.30) 70 | −141.43 (−252.23 to −30.63) 0.01 −128.10 (−254.31 to −1.89) 0.05 | Inconclusive Inconclusive |
*Adjusted for baseline score.
CRQ-SR, Chronic Respiratory Questionnaire Self-Report; ESWT, endurance shuttle walk test; HADS, Hospital Anxiety and Depression Scale; ISWT, incremental shuttle walk test; mITT, modified intention to treat—all participants according to random allocation with outcome data; N, number of participants; PP, per protocol—participants according to random allocation with outcome data and attending final outcome assessment; PRAISE, Pulmonary Rehabilitation Adapted Index of Self-Efficacy.