Table 1.
Participant characteristics and outcomes at baseline
| Descriptor | Total (n=119*) |
Control (n=60*) | Intervention (n=59*) |
| Demographics | |||
| Age in years, mean (SD) | 50.61 (10.98) | 52.03 (11.10) | 49.17 (10.75) |
| Gender, n (%) | |||
| Male | 53 (44.5) | 26 (43.3) | 27 (45.8) |
| Female | 66 (55.5) | 34 (56.7) | 32 (54.2) |
| In-hospital treatment modalities | |||
| Days from onset to admission, mean (SD) | 7.47 (9.80) | 7.05 (10.60) | 7.90 (8.97) |
| Disease severity†, n (%) | |||
| Not severe | 81 (68.1) | 44 (73.3) | 37 (62.7) |
| Severe | 38 (31.9) | 16 (26.7) | 22 (37.3) |
| Oxygen support or non-invasive ventilation, n (%) | |||
| Yes | 103 (86.6) | 54 (90.0) | 49 (83.1) |
| Treatment with corticosteroids, n (%) | |||
| Yes | 49 (41.2) | 23 (38.3) | 26 (44.1) |
| Length of inpatient stay, mean (SD) | 26.18 (15.25) | 23.73 (11.00) | 28.66 (18.37) |
| Medical history (baseline) | |||
| Comorbidity presence, n (%) | |||
| None | 46 (38.7) | 21 (35.0) | 25 (42.4) |
| Single | 45 (37.8) | 24 (40.0) | 21 (35.6) |
| Multi | 28 (23.5) | 15 (25.0) | 13 (22.0) |
| Comorbidity types, n (%) | |||
| Heart disease | 9 (7.6) | 7 (11.7) | 2 (3.4) |
| Hypertension | 26 (21.9) | 18 (30.0) | 8 (13.6) |
| Diabetes | 17 (14.3) | 9 (15.0) | 8 (13.6) |
| Obesity | 17 (14.3) | 8 (13.33) | 9 (15.3) |
| Lung disease (including inactive TB) | 7 (5.9) | 3 (5.0) | 4 (6.8) |
| Other comorbidity | 28 (23.5) | 12 (20.0) | 16 (27.1) |
| Smoking history, n (%) | |||
| Yes | 15 (12.6) | 6 (10.0) | 9 (15.3) |
| Trial information | |||
| Days from hospital discharge to baseline, mean (SD) | 70.07 (16.85) | 71.15 (13.22) | 68.97 (19.94) |
| Days from baseline to post-treatment assessment, mean (SD)‡ | 42.86 (2.12) | 43.02 (1.87) | 42.67 (2.37) |
| Days from baseline to follow-up assessment, mean (SD)§ | 197.30 (8.41) | 196.87 (8.26) | 197.78 (8,62) |
| Outcomes (baseline) | |||
| 6MWD (m), mean (SD) | 507.18 (88.27) | 499.98 (93.41) | 514.52 (82.87) |
| Squat time (s), mean (SD) | 36.66 (23.51) | 38.60 (25.07) | 34.68 (21.85) |
| Spirometry¶ | |||
| FEV1 (L), mean (SD) | 2.19 (0.71) | 2.14 (0.69) | 2.24 (0.74) |
| FEV1 (% predicted), mean (SD) | 78.53 (16.86) | 77.95 (15.45) | 79.10 (18.25) |
| FEV1 below LLN, n (%) | 50 (43.5) | 24 (42.1) | 26 (44.8) |
| FVC (L), mean (SD) | 2.77 (0.82) | 2.69 (0.87) | 2.85 (0.75) |
| FVC (% predicted), mean (SD) | 82.04 (15.20) | 80.43 (15.39) | 83.62 (14.99) |
| FVC below LLN, n (%) | 45 (39.1) | 22 (38.6) | 23 (39.7) |
| FEV1/FVC | 0.80 (0.13) | 0.81 (0.12) | 0.79 (0.14) |
| FEV1/FVC (% predicted), mean (SD) | 96.43 (15.93) | 97.86 (15.03) | 95.03 (16.78) |
| FEV1/FVC below LLN, n (%) | 26 (22.6) | 12 (21.1) | 14 (24.1) |
| MVV (L/min) | 68.72 (28.90) | 63.05 (26.12) | 74.30 (30.60) |
| MVV (% predicted), mean (SD) | 62.69 (22.13) | 58.94 (20.86) | 66.37 (22.88) |
| PEF (L/s) | 3.93 (2.07) | 3.66 (1.75) | 4.21 (2.33) |
| PEF (% predicted), mean (SD) | 48.94 (21.77) | 46.41 (18.20) | 51.42 (24.70) |
| SF-12 PCS, mean (SD) | 39.42 (7.09) | 39.69 (7.06) | 39.15 (7.16) |
| SF-12 MCS, mean (SD) | 44.40 (8.48) | 44.13 (8.25) | 44.67 (8.76) |
| mMRC-dyspnoea, n (%) | |||
| 2 ‘On level ground, walks slower than people of same age because of breathlessness or has to stop for breath when walking at own pace’. | 116 (97.5) | 58 (96.7) | 58 (98.3) |
| 3 ‘Stops for breath after walking about 100 yards or after a few minutes on level ground’. | 3 (2.5) | 2 (3.3) | 1 (1.7) |
*Unless otherwise stated.
†Cases were defined as severe when patients met one of the following criteria at any time during hospitalisation: acute respiratory distress, respiratory rate ≥30 breath/min; pulse oxygen saturation (SpO2) ≤93% at rest; arterial blood partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤300 mm Hg (1 mm Hg=0.133 kPa); respiratory failure requiring mechanical ventilation; septic shock; failure of other organs requiring intensive care unit treatment.42
‡n=112 (control=60, intervention=52).
§n=105 (control=55, intervention=50).
¶For spirometry n=115 (control=57, intervention=58); one baseline value missing, three invalid entries in case record form. FEV1, FCV, FEV1/FVC predictions and lower limits of normal according to Global Lung Initiative 2012,21 MVV, PEF predictions according to Mu and Liu.22
MCS, mental component score; mMRC, modified Medical Research Council; MVV, maximum voluntary ventilation; PCS, physical component score; PEF, peak expiratory flow; SF-12, Short Form Health Survey-12.