Efficacy results (per-protocol analysis set) of Urban Training intervention at 12 months in chronic obstructive pulmonary disease (COPD) patients
| Usual care# | Urban Training# | Adjusted difference (95% CI) at 12 months¶ | |||
| Baseline | 12 months | Baseline | 12 months | ||
| Subjects n | 145 | 88 | |||
| Primary outcome | |||||
| Steps per day | 7846±3845 | 7911±3830 | 8355±4177 | 9171±4704+ | 957 (184–1731)§ |
| Secondary outcomes | |||||
| Any severe COPD exacerbation in previous 12 months % | 14 | 16+ | 5 | 15+ | 0.15 (−0.7–1) |
| 6MWD m | 503±79 | 496±86+ | 509±83 | 502±97 | 3.6 (−6.9–14.2) |
| BMI kg·m−2 | 28.2±4.5 | 28.2±4.5 | 28.3±4.5 | 28.5±4.5 | 0.2 (−0.2–0.5) |
| FFMI kg·m−2 | 19.6±3.2 | 19.5±3.0 | 19.5±2.8 | 19.5±2.8 | 0.1 (−0.4–0.6) |
| Health-related quality of life CAT | 12±8 | 11±7+ | 12±7 | 10±7+ | −0.7 (−2.1–0.6) |
| Health-related quality of life CCQ total | 1±1 | 1±1 | 1±1 | 1±1 | −0.1 (−0.3–0.1) |
| Anxiety HAD-A | 5±4 | 4±4+ | 5±4 | 5±4 | 0.2 (−0.5–0.9) |
| Depression HAD-D | 3±3 | 3±3 | 3±3 | 2±3+ | −0.5 (−1.1–0.1) |
| Exploratory outcomes | |||||
| Cognitive status (phototest) | 37±5 | 36±5 | 36±5 | 36±6 | 0.5 (−0.4–1.5) |
| Physical activity experience (C-PPAC total score) | 79±12 | 78±11 | 79±11 | 84±11+ | 5.2 (1.3–9.2)+ |
| Physical activity experience of amount (C-PPAC amount) | 75±15 | 74±14 | 76±12 | 80±13+ | 5.7 (1.1–10.2)+ |
| Physical activity experience of difficulty (C-PPAC difficulty) | 83±13 | 81±13 | 83±16 | 88±14+ | 5.0 (0.3–9.6)+ |
Data are presented as n, mean±sd or adjusted difference (95% CI). 6MWD: 6-min walking distance; BMI: body mass index; FFMI: fat-free mass index; CAT: COPD Assessment Test; CCQ: Clinical COPD Questionnaire; HAD: Hospital Anxiety and Depression Scale; C-PPAC: Clinical visit – PROactive Physical Activity in COPD (higher numbers indicate a better score). #: some variables have missing values, as follows. At baseline in the usual-care group: severe COPD exacerbations (n=1), FFMI (n=18), HAD-A (n=2), HAD-D (n=2), C-PPAC total (n=24), C-PPAC amount (n=23) and C-PPAC difficulty (n=24); at 12 months in the usual-care group: severe COPD exacerbations (n=5), 6MWD (n=7), BMI (n=2), FFMI (n=2), CAT (n=1), CCQ total (n=1), HAD-A (n=1), HAD-D (n=1), cognitive status (n=1) and C-PPAC total, amount and difficulty scores (n=63); at baseline in Urban Training group: severe COPD exacerbations (n=1), FFMI (n=5), HAD-D (n=1) and C-PPAC total, amount and difficulty scores (n=24); at 12 months in Urban Training group: severe COPD exacerbations (n=2), 6MWD (n=1), CCQ total (n=1), HAD-D (n=1) and C-PPAC total, amount and difficulty scores (n=47); ¶: multivariable models (linear regression for all outcomes except exacerbations where logistic regression was used) adjusted by group, forced expiratory volume in 1 s/forced vital capacity ratio, smoking, diabetes, HAD-depression score (online supplementary material) and the corresponding outcome values at baseline; +: p-value of final versus baseline <0.05; §: p-value for group differences <0.05.