TABLE 3.
Mean Scores on the Outcome Measures Over the Study Period
| Outcome Measures | Follow-Up Assessment | |||||
|---|---|---|---|---|---|---|
| 3 mo (T1) | 6 mo (T2) | 12 mo (T3) | ||||
| Experimental Group (n = 40) | Control Group (n = 22) | Experimental Group (n = 30) | Control Group (n = 20) | Experimental Group (n = 27) | Control Group (n = 34) | |
| Medical and clinical characteristics | ||||||
| NIV hours, mean (SD) | ||||||
| Prescribed hours | 8.63 (1.47) | 7.78 (2.13) | 8.87 (1.45) | 8.52 (1.5) | 8.73 (1.04) | 8.41 (2.06) |
| Effective hours | 6.11 (3.65) | 3.83 (3.44) | 4.16 (4.18) | 2.69 (3.37) | 8.02 (1.78) | 6.15 (2.66) |
| Difference | 0.73 (2.00) | 1.51 (2.41) | 0.64 (1.17) | 0.98 (2.01) | 0.35 (1.50) | 0.84 (2.03) |
| ADL, mean (SD) | 1.20 (1.77) | 0.21 (0.60) | 1.26 (1.94) | 0.33 (0.80) | 0.93 (1.68) | 0.27 (0.57) |
| IADL, mean (SD) | 3.01 (1.80) | 2.91 (1.47) | 3.33 (1.49) | 2.71 (1.62) | 3.18 (1.28) | 2.88 (1.74) |
| FSS, mean (SD) | 41.38 (13.94) | 43.75 (14.45) | 40.78 (13.53) | 33.88 (16.01) | 39.52 (13.76) | 42.70 (12.03) |
| Spirometry, mean (SD) | ||||||
| FEV1 | 0.83 (0.41) | 1.41 (0.77) | 0.93 (0.29) | 1.49 (0.81) | 1.33 (0.77) | 1.41 (1.02) |
| FEV1% | 45.67 (18.4) | 54.04 (23.70) | 46.43 (21.67) | 60.18 (30.05) | 53 (30.58) | 71.71 (43.11) |
| FVC | 1.53 (0.61) | 2.43 (0.85) | 1.15 (1.20) | 1.94 (0.69) | 2.011 (0.85) | 2.27 (1.65) |
| FVC% | 56.24 (19.76) | 71.85 (20.56) | 63.92 (17.38) | 68.90 (23.03) | 68.26 (27.78) | 72.50 (51.17) |
| FEV1/FVC | 0.55 (0.97) | 0.64 (0.20) | 0.68 (0.11) | 0.565 (0.11) | 0.60 (0.18) | 65.56 (10.82) |
| FEV1/FVC% | 66.36 (15.18) | 60.40 (29.08) | 73.64 (23.77) | 74.44 (23.34) | 75.08 (20.93) | 58.15 (28.27) |
| EGA, mean (SD) | ||||||
| pH | 7.40 (0.03) | 7.42 (0.05) | 7.39 (0.55) | 7.44 (0.03) | 7.00 (0.00) | 7.45 (0.03) |
| Pao2 | 65.53 (10.28) | 71.21 (17.23) | 64.90 (5.70) | 63.78 (10.12) | 69.53 (10.66) | 70.20 (5.44) |
| PaCO2 | 52.20 (9.44) | 50.29 (14.53) | 52.00 (7.46) | 58.89 (27.67) | 47.30 (6.31) | 41.60 (5.02) |
| HCO3 | 30.00 (9.62) | 29.31 (5.01) | 31.94 (13.71) | 27.24 (10.14) | 30.572 (4.49) | 38.80 (12.49) |
| Psychological and cognitive features | ||||||
| Psychological variables | ||||||
| HADS, mean (SD) | ||||||
| Tot. | 9.78 (5.81) | 10.88 (8.05) | 10.78 (6.51) | 6.55 (5.27) | 9.66 (6.48) | 9.00 (6.37) |
| HADS-A | 5.83 (4.17) | 5.31 (5.23) | 6.07 (4.12) | 3.11 (3.82) | 6.22 (4.41) | 5.50 (5.01) |
| HADS-D | 4.50 (1.91) | 5.69 (3.53) | 4.71 (2.86) | 3.44 (2.78) | 3.44 (2.89) | 3.50 (2.17) |
| EQ-5D, mean (SD) | ||||||
| Algorithm | 0.29 (0.40) | 0.23 (0.62) | 0.35 (0.349) | 0.70 (0.48) | 0.26 (0.35) | 0.43 (0.51) |
| VAS | 60.83 (20.88) | 59.06 (15.97) | 71.07 (16.54) | 68.50 (15.28) | 64.16 (15.55) | 66 (13.49) |
| QAF, mean (SD) | ||||||
| Tot. | 54.38 (4.10) | 55.26 (5.20) | 53.92 (6.78) | 54.77 (5.33) | 53.47 (6.69) | 53.30 (5.12) |
| B-IPQ, mean (SD) | 43.66 (7.53) | 37.05 (14.80) | 34.92 (14.31) | 33.5 (9.02) | 35.11 (13.02) | 37.80 (13.00) |
| ROSES, mean (SD) | 31.77 (5.96) | 31.93 (6.12) | 35.85 (3.61) | 33.77 (3.52) | 34.20 (3.12) | 29.60 (8.82) |
| Cognitive variables | ||||||
| MMSE, mean (SD) | N/A | N/A | 27.81 (1.60) | 27.75 (1.50) | 27.30 (2.25) | 26.20 (3.56) |
| MMSE Adj., mean (SD) | N/A | N/A | 26.42 (1.51) | 27.33 (1.15) | 26.72 (1.40) | 25.00 (2.58) |
| ACE-R, mean (SD) | ||||||
| Tot. | N/A | N/A | 84.30 (8.43) | 79.5 (8.66) | 78.76 (9.40) | 75.80 (15.97) |
| Tot. ACE-R Adj. | N/A | N/A | 92.70 (7.90) | 96.25 (6.18) | 87.75 (9.22) | 86.40 (11.88) |
| DI, mean (SD) | 2.11 (3.56) | 0.53 (0.99) | 0.88 (1.72) | 0 (0.0) | 0.78 (1.88) | 0.25 (0.70) |
n = number of subjects; NIV = noninvasive ventilation; SD = standard deviation; ADL = activities of daily living; IADL = instrumental activities of daily living; FSS = Fatigue Severity Scale; FEV1 = forced expiratory volume in the first second; FVC = forced vital capacity; FEV1/FVC = ratio between forced expiratory volume in the first second and forced vital capacity or Tiffeneau Index; EGA = hemogasanalysis; pH = potential of hydrogen; Pao2 = partial pressure of oxygen in arterial blood; Paco2 = partial pressure of carbon dioxide in arterial blood; HCO3 = hydrogen carbonate concentration; HADS = Hospital Anxiety and Depression Scale; Tot. = total score; HADS-A = Hospital Anxiety and Depression Scale—Anxiety; HADS-D = Hospital Anxiety and Depression Scale—Depression; EQ-5D = EuroQoL-5D Questionnaire; VAS = visual analog scale; QAF = Questionnaire on Adhesion to Pharmacological and Dietetic Therapy; B-IPQ = Brief Illness Perception Questionnaire; ROSES = Rosenberg’s Self-Esteem Scale; MMSE = Mini-Mental Status Examination; N/A = not applicable; MMSE Adj. = Mini Mental Status Examination corrected; ACE-R = Addenbrooke’s Cognitive Examination Test—Revised; DI = Delirium Index.