Table 2.
Adjusted intention-to-treat analyses and per-protocol analyses of Mini-Asthma Quality of Life Questionnaire and secondary outcomes at 6 months
| Total No. of Assessments* |
Intent-to-Treat Population |
|||||||
|---|---|---|---|---|---|---|---|---|
| UC + BrEX (n = 94) | UC (n = 99) | Between-Group Difference | ||||||
| UC + BrEX | UC | Mean Change | Mean Change | Difference in Mean Change | ||||
| Mini-AQLQ | 262 | 287 | 0.65 | (0.46 to 0.85) | 0.31 | (0.12 to 0.49) | 0.35 | (0.07 to 0.62) |
| ACQ6 | 256 | 285 | −0.32 | (−0.5 to −0.15) | −0.21 | (−0.38 to −0.05) | −0.11 | (−0.35 to 0.13) |
| NQ | 255 | 285 | −3.83 | (−5.52 to −2.13) | −2.78 | (−4.39 to −1.17) | −1.05 | (−3.38 to 1.29) |
| HADS-anxiety | 255 | 284 | −1.06 | (−1.73 to −0.38) | −1.11 | (−1.75 to −0.47) | 0.06 | (−0.87 to 0.98) |
| HADS-depression | 255 | 284 | −1.16 | (−1.71 to −0.61) | −0.26 | (−0.78 to 0.27) | −0.90 | (−1.67 to −0.14) |
| 6MWT (m) | 160 | 176 | 2.03 | (−10.2 to 14.27) | 9.03 | (−2.44 to 20.5) | −7.00 | (−23.77 to 9.77) |
| FEV1% pred | 150 | 163 | 0.48 | (−2.19 to 3.14) | −0.53 | (−3.01 to 1.96) | 1.00 | (−2.64 to 4.65) |
| Steps per day | 82 | 89 | 84.74 | (−973.24 to 1,142.72) | −245.85 | (−1282.1 to 790.4) | 330.59 | (−1149.86 to 1,811.04) |
| PAL | 82 | 89 | 0.03 | (−0.02 to 0.08) | −0.02 | (−0.06 to 0.03) | 0.05 | (−0.02 to 0.11) |
| Total No. of Assessments* |
Per-Protocol Population |
|||||||
|---|---|---|---|---|---|---|---|---|
| UC + BrEX (n = 76) | UC (n = 99) | Between-Group Difference | ||||||
| UC+BrEX | UC | Mean Change | Mean Change | Difference in Mean Change | ||||
| Mini-AQLQ | 222 | 287 | 0.68 | (0.47 to 0.89) | 0.31 | (0.12 to 0.49) | 0.38 | (0.1 to 0.66) |
| ACQ6 | 216 | 285 | −0.39 | (−0.58 to −0.2) | −0.21 | (−0.38 to −0.05) | −0.18 | (−0.43 to 0.07) |
| NQ | 215 | 285 | −4.03 | (−5.88 to −2.19) | −2.78 | (−4.41 to −1.16) | −1.25 | (−3.71 to 1.21) |
| HADS-anxiety | 215 | 284 | −1.13 | (−1.84 to −0.42) | −1.11 | (−1.74 to −0.48) | −0.02 | (−0.97 to 0.93) |
| HADS-depression | 215 | 284 | −1.46 | (−2.03 to −0.89) | −0.26 | (−0.76 to 0.25) | −1.20 | (−1.97 to −0.44) |
| 6MWT (m) | 140 | 176 | 2.50 | (−10.2 to 15.19) | 9.03 | (−2.53 to 20.58) | −6.53 | (−23.69 to 10.63) |
| FEV1% pred | 131 | 163 | 0.87 | (−1.89 to 3.63) | −0.52 | (−3.02 to 1.99) | 1.39 | (−2.34 to 5.11) |
| Steps per day | 79 | 89 | 139.09 | (−921.97 to 1,200.14) | −248.85 | (−1282.53 to 784.83) | 387.93 | (−1093.4 to 1,869.27) |
| PAL | 79 | 89 | 0.03 | (−0.02 to 0.08) | −0.01 | (−0.06 to 0.03) | 0.05 | (−0.02 to 0.11) |
Definition of abbreviations: 6MWT = 6-min-walk test; ACQ6 = 6-item Asthma Control Questionnaire; FEV1% pred = predicted percentage of forced expiratory volume in the first second; HADS = Hospital Anxiety and Depression Scale; Mini-AQLQ = Mini-Asthma Quality of Life Questionnaire; NQ = Nijmegen Questionnaire; PAL = average physical activity level per day; UC = usual care alone; UC + BrEX = breathing exercises and usual care.
Data are adjusted mean change from baseline to 6 months including 95% confidence interval.
Possible assessments for questionnaires (at baseline + at 3 mo + at 6 mo): 282 for UC + BrEX (in per-protocol: 228) and 297 for UC; for FEV1% pred and 6MWT (at baseline + at 6 mo): 188 for UC + BrEX (in per-protocol: 152) and 198 for UC; steps per day and PAL (at baseline + at 3 mo + at 6 mo): 135 for UC + BrEX (in per-protocol population: 126) and 144 for UC.