TABLE 3.
Effectiveness results (intention to treat 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 | 148 | 132 | |||
| Primary outcome | |||||
| Steps per day | 7783±3847 | 7825±3850 | 8069±4554 | 8002±4635 | −24 (−741–693) |
| Secondary outcomes | |||||
| Any severe COPD exacerbation in previous 12 months % | 14 | 17+ | 8 | 17+ | 0.3 (−0.4–1.0) |
| 6MWD m | 501±83 | 493±90+ | 499±95 | 488±106+ | −1.5 (−11–8) |
| BMI kg·m−2 | 28.3±4.6 | 28.3±4.5 | 28.4±5.0 | 28.5±5.2 | 0.0 (−0.3–0.4) |
| FFMI kg·m−2 | 19.6±3.2 | 19.5±3.0 | 19.6±3.0 | 19.6±3.1 | 0.1 (−0.4–0.5) |
| Health-related quality of life (CAT) | 12±8 | 11±7 | 12±7 | 11±7+ | 0.1 (−1.1–1.2) |
| 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 (−0.4–0.9) |
| Depression (HAD-D) | 3±3 | 3±3 | 4±3 | 3±3+ | −0.5 (−1.0–0.1) |
| Exploratory outcomes | |||||
| Cognitive status (phototest) | 37±5 | 36±5 | 36±5 | 37±5 | 0.6 (−0.2–1.5) |
| Physical activity experience (C-PPAC total) | 79±12 | 77±12 | 78±12 | 80±14 | 2.6 (−0.8–6.0) |
| Physical activity experience of amount (C-PPAC amount) | 75±15 | 73±15 | 74±15 | 74±18 | 1.5 (−2.5–5.5) |
| Physical activity experience of difficulty (C-PPAC difficulty) | 83±13 | 81±14 | 82±15 | 85±15+ | 3.8 (−0.2–7.9) |
Data are presented as mean±sd, unless otherwise stated. 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=25), C-PPAC amount (n=24) and C-PPAC difficulty (n=25); at 12 months in the usual-care group: severe COPD exacerbations (n=5), 6MWD (n=8), BMI (n=3), FFMI (n=3), CAT (n=2), CCQ total (n=2), HAD-A (n=2), HAD-D (n=2), cognitive status (n=2) and C-PPAC total, amount and difficulty scores (n=64); at baseline in Urban Training group: severe COPD exacerbations (n=2), FFMI (n=12), CCQ total (n=2), HAD-D (n=1) and C-PPAC total, C-PPAC amount and C-PPAC difficulty (n=35); at 12 months in Urban Training group: severe COPD exacerbations (n=5), 6MWD (n=3), BMI (n=2), FFMI (n=2), CAT (n=2), CCQ total (n=3), HAD-A (n=2), HAD-D (n=4), cognitive status (n=2) and C-PPAC total, amount and difficulty scores (n=70); ¶: multivariable models (linear regression for all outcomes except exacerbations where logistic regression was used) adjusted by group and the corresponding outcome values at baseline; + p-value of final versus baseline <0.05.