Characteristics by randomisation group and site
| Baseline characteristic | All# | Boston¶ | Birmingham+ | Between-site p-value | ||||
| Intervention | Control | Between-group p-value | Intervention | Control | Intervention | Control | ||
| Subjects n | 75 | 78 | 54 | 54 | 21 | 24 | ||
| Age years | 69.2±7.2 | 70.4±7.3 | 0.307 | 70.4±7.4 | 70.8±7.5 | 65.8±5.7 | 69.4±7.0 | 0.024 |
| Male, n (%) | 70 (93) | 72 (92) | 0.806 | 52 (96) | 51 (94) | 18 (86) | 21 (87.5) | 0.058 |
| White, n (%) | 69 (92) | 69 (89) | 0.462 | 51 (94) | 50 (93) | 18 (86) | 19 (79.2) | 0.032 |
| BOS, n (%) | 54 (72) | 54 (69) | 0.707 | – | – | – | – | – |
| Annual income <USD 30 000, n (%) | 32 (43) | 34 (44) | 0.908 | 18 (33) | 20 (37) | 14 (67) | 14 (58.3) | 0.002 |
| Greater than high school education, n (%) | 53 (71) | 63 (81) | 0.145 | 38 (70) | 46 (85) | 15(71) | 17 (71) | 0.380 |
| Rural, n (%) | 4 (5) | 11 (14) | 0.068 | 0 (0.00) | 4 (7) | 4 (19) | 7 (29) | <0.001 |
| FEV1 % predicted | 60.6±23.1 | 61.5±19.8 | 0.794 | 68.1±20.4 | 64.7±18.6 | 41.51±18.3 | 54.5±20.9 | <0.001 |
| Current oxygen use, n (%) | 19 (25) | 22 (28) | 0.689 | 8 (15) | 8 (15) | 11 (52) | 14 (58) | <0.001 |
| 6MWT | 360.8±92.0 | 357.2±103.5 | 0.822 | 381.7±90.9 | 382.6±106.3 | 307.0±72.4 | 300.1±70.1 | <0.001 |
| Daily step-count | 3176.6±2211.6 | 3210.2±2247.9 | 0.926 | 3385.0±2197.2 | 3516.0±2511.7 | 2640.8±2210.1 | 2522.1±1290.5 | 0.013 |
| SGRQ-TS | 40.0±15.3 | 38.0±17.8 | 0.474 | 36.3±14.4 | 32.2±14.7 | 49.4±13.6 | 53.4±16.3 | <0.001 |
| mMRC dyspnoea | 2.0±1.2 | 2.1(1.2 | 0.596 | 2.1±1.3 | 2.1±1.3 | 1.8±0.8 | 2.2±1.1 | 0.578 |
| BCKQ | 46.9±15.0 | 46.1±16.2 | 0.751 | 46.3±12.7 | 47.3±15.5 | 48.6±20.2 | 42.8±18.0 | 0.773 |
| MOS-SS | 76.8±23.8 | 69.4±27.7 | 0.081 | 74.5±25.5 | 70.6±29.6 | 83.0±17.5 | 65.9±22.1 | 0.702 |
| Adverse events (n=114)§ | ||||||||
| Serious non-COPD adverse event, n (%) | 7 (12) | 9 (17) | 0.443 | 6 (13) | 9 (22) | 1 (7) | 0 (0) | 0.077 |
| Musculoskeletal adverse event, n (%) | 32 (53) | 23 (43) | 0.252 | 27 (59) | 23 (56) | 5 (36) | 0 (0) | 0.001 |
All values represent the mean±sd unless otherwise noted. BOS: Boston site; FEV1: mean forced expiratory volume in 1 s; 6 MWT: 6-minute walk test; SGRQ-TS: St. George's Respiratory Questionnaire – Total Score; mMRC: modified Medical Research Council; BCKQ: Bristol COPD Knowledge Questionnaire; MOS-SS: Medical Outcomes Study Social Support Survey. #: n=153. ¶: n=108. +: n=45. §: Number of participants who provided information about adverse events.