Baseline characteristics of the eligible subjects by self-management behaviour modification (SMBM) group (n=304)
| Variables | Total | T/O FDC (5/5 µg)+SMBM+ExT | T/O FDC (5/5 µg)+SMBM | T (5 µg)+SMBM | Placebo+SMBM |
| Subjects n | 304 | 76 | 76 | 76 | 76 |
| Demographics | |||||
| Age years | 64.8±6.6 | 64.8±6.5 | 64.9±6.9 | 65.1±6.4 | 64.4±6.6 |
| Males | 201 (66.1%) | 45 (59.2%) | 48 (63.2%) | 55 (72.4%) | 53 (69.7%) |
| BMI kg·m2 | 29.0±21.3 | 28.1±5.3 | 27.3±5.0 | 32.1±41.8 | 28.3±4.7 |
| Ever-smokers | 192 (63.2%) | 48 (63.2%) | 47 (61.8%) | 49 (64.5%) | 48 (63.2%) |
| Current smokers | 112 (36.8%) | 28 (36.8%) | 29 (38.2%) | 27 (35.5%) | 28 (36.8%) |
| Smoking history pack-years | 46.9±23.8 | 46.1±24.2 | 41.9±19.6 | 51.0±28.0 | 48.6±22.0 |
| Symptoms and clinical data | |||||
| mMRC dyspnoea score | 1.3±0.9 | 1.3±0.9 | 1.3±0.9 | 1.3±0.8 | 1.4±0.8 |
| Chronic bronchitis | 143 (47.0%) | 40 (52.6%) | 39 (51.3%) | 34 (44.7%) | 30 (39.5%) |
| Sputum-producing cough | 184 (60.5%) | 49 (64.5%) | 43 (56.6%) | 44 (57.9%) | 48 (63.2%) |
| Emphysema | 140 (46.1%) | 38 (50.0%) | 33 (43.4%) | 33 (43.4%) | 36 (47.4%) |
| SGRQ total score | 40.1±15.7 | 39.1±16.0 | 40.6±17.1 | 39.1±15.3 | 41.7±14.5 |
| MoCA total score | 25.6±3.1 | 25.8±2.9 | 25.3±3.4 | 25.4±3.0 | 25.8±3.1 |
| HADS-A score | 4.8±3.2 | 4.7±3.4 | 4.6±3.2 | 5.2±3.2 | 4.9±3.2 |
| HADS-D score | 3.8±2.7 | 3.7±3.0 | 3.3±2.4 | 4.2±2.8 | 4.1±2.4 |
| PHQ-9 total score | 4.6±3.8 | 4.1±3.9 | 4.2±3.4 | 5.0±4.0 | 5.0±3.8 |
| Lung function | |||||
| FEV1 L | 1.4±0.5 | 1.3±0.5 | 1.4±0.4 | 1.4±0.4 | 1.4±0.5 |
| FEV1 % predicted | 48.7±13.2 | 49.1±13.3 | 49.6±12.5 | 48.8±13.9 | 47.2±13.3 |
| FEV1/FVC % | 47.0±10.5 | 46.5±9.8 | 48.7±11.8 | 46.8±9.9 | 45.9±10.3 |
| COPD GOLD stages 1–2 | 129 (42.4%) | 35 (46.1%) | 34 (44.7%) | 30 (39.5%) | 30 (39.5) |
| COPD GOLD stages 3–4 | 169 (55.6%) | 40 (52.6%) | 38 (50.0%) | 46 (60.5%) | 45 (59.2) |
| Exercise function | |||||
| ESWT | |||||
| Walk distance m | 404.6±290.1 | 428.9±335.2 | 436.8±300.2 | 388.9±265.4 | 363.8±252.0 |
| Walk duration min | 4.9±3.3 | 5.3±3.8 | 5.2±3.4 | 4.8±3.0 | 4.5±3.0 |
| Shuttles | 40.5±29.0 | 42.9±33.5 | 43.7±30.0 | 38.9±26.5 | 36.4±25.2 |
| Walk distance in 6MWT m | 448.2±101.2 | 435.9±106.6 | 458.0±100.4 | 450.2±94.7 | 448.7±103.6 |
| Activity monitor/pedometer | |||||
| Steps per day | 5423.1±2820.2 | 5590.2±2683.4 | 5723.2±3065.9 | 5162.6±2767.9 | 5223.7±2769.6 |
| Walking duration min | 67.0±32.3 | 68.4±30.4 | 69.9±36.3 | 64.5±31.0 | 65.3±31.7 |
| Walking intensity ×g | 0.2±0.0 | 0.2±0.0 | 0.2±0.0 | 0.2±0.0 | 0.2±0.0 |
Data are presented as mean±sd unless otherwise stated. p-values were obtained by performing ANOVA or Kruskal–Wallis test for continuous variable and Chi-Square test for category variables. T: tiotropium; O: olodaterol; FDC: fixed-dose combination; ExT: exercise training; BMI: body mass index; mMRC: modified Medical Research Council; SGRQ: St George's Respiratory Questionnaire; MoCA: Montreal Cognitive Assessment; HADS: Hospital Anxiety and Depression Scale; A: anxiety; D: depression; PHQ: Patient-Health Questionnaire; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; ESWT: endurance shuttle walk test; 6MWT: 6-min walk test.