Between-group difference in primary and secondary outcomes at 6 months 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 | 2.80 (1.17) 66 2.77 (1.14) 64 | 3.08 (1.26) 70 3.08 (1.27) 68 | −0.36 (−0.75 to 0.03) 0.07 −0.39 (−0.79 to 0.002) 0.05 | Inconclusive Inconclusive |
| CRQ-SR fatigue mITT PP | 3.53 (1.40) 67 3.52 (1.38) 65 | 3.60 (1.31) 71 3.58 (1.31) 69 | −0.18 (−0.58 to 0.22) 0.38 −0.18 (−0.58 to 0.23) 0.39 | Inconclusive Inconclusive |
| CRQ-SR emotion mITT PP | 4.34 (1.34) 67 4.35 (1.34) 65 | 4.49 (1.24) 71 4.48 (1.24) 69 | −0.29 (−0.64 to 0.05) 0.09 −0.31 (−0.66 to 0.04) 0.08 | Inconclusive Inconclusive |
| CRQ-SR mastery mITT PP | 4.55 (1.49) 67 4.55 (1.45) 65 | 4.61 (1.43) 71 4.60 (1.44) 69 | −0.30 (−0.71 to 0.10) 0.14 −0.30 (−0.71 to 0.11) 0.15 | Inconclusive Inconclusive |
| HADS anxiety mITT PP | 7.31 (4.29) 68 7.32 (4.27) 66 | 7.96 (4.18) 73 8.02 (4.20) 71 | 0.13 (−0.93 to 1.19) 0.81 0.21 (−0.87 to 1.29) 0.70 | Non-inferior Non-inferior |
| HADS depression mITT PP | 6.26 (3.57) 68 6.30 (3.55) 66 | 6.52 (3.59) 73 6.54 (3.58) 71 | 0.07 (−0.92 to 1.07) 0.88 0.14 (−0.85 to 1.14) 0.78 | Inconclusive Inconclusive |
| PRAISE mITT PP | 43.21 (8.87) 68 43.20 (8.81) 66 | 44.11 (8.79) 72 44.16 (8.87) 70 | −1.15 (−3.97 to 1.67) 0.42 −1.05 (−3.93 to 1.83) 0.47 | No non-inferiority margin No non-inferiority margin |
| ISWT distance (m) mITT PP | 248.14 (151.86) 59 247.24 (153.03) 58 | 270.00 (150.94) 66 271.25 (153.05) 64 | −5.46 (−32.98 to 22.05) 0.70 −5.87 (−33.99 to 22.25) 0.68 | Non-inferior Non-inferior |
| ESWT time (s) mITT PP | 408.27 (420.09) 59 407.03 (423.65) 58 | 444.70 (414.89) 67 445.02 (417.44) 65 | −67.83 (−207.69 to 72.04) 0.34 −69.58 (−212.23 to 73.07) 0.34 | 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.