Table 3.
Monthly change in secondary and exploratory physical function and nutritional outcome variables in the modified intention‐to‐treat population (patients assessed at discharge)
| Endpoint |
Control formula Within‐group change (N = 63) |
Experimental formula Within‐group change (N = 64) |
Treatment effect Between‐group difference a |
P‐value |
|---|---|---|---|---|
| Secondary outcome variables | ||||
| MMSE (score) | −0.11 (−0.16 to −0.05) a | 0.46 (0.25 to 0.66) a | 0.57 (0.352 to 0.773) | <0.001 |
| Trail making test (s) | −0.12 (−0.48 to 0.23) | −3.32 (−4.01 to −2.63) a | −3.20 (−3.97 to −2.43) | <0.001 |
| Barthel index (score) | 0.92 (−0.15 to 1.99) | 5.02 (3.77 to 6.27) a | 4.10 (2.47 to 5.73) | <0.001 |
| Activities of daily living (score) | 0.01 (−0.10 to 0.12) | 0.67 (0.51 to 0.83) a | 0.66 (0.46 to 0.85) | <0.001 |
| Tinetti scale (score) | −0.27 (−0.57 to 0.03) | 2.09 (1.67 to 2.52) a | 2.36 (1.85 to 2.88) | <0.001 |
| Body weight (kg) | −0.90 (−1.09 to −0.70) a | 1.55 (1.35 to 1.76) a | 2.45 (2.17 to 2.73) | <0.001 |
| Handgrip strength (kg) | −1.47 (−2.01 to −0.92) a | 3.98 (3.20 to 4.75) a | 5.45 (4.51 to 6.38) | <0.001 |
| SF‐12 PCS (score) | 0.16 (−1.09 to 1.40) | 1.47 (0.68 to 2.26) a | 1.31 (−0.15 to 2.77) | 0.08 |
| SF‐12 MCS (score) | 1.38 (0.61 to 2.16) a | 1.25 (0.28 to 2.222) a | −0.13 (−1.367 to 1.098) | 0.82 |
| Appendicular muscle mass (g) | −69.4 (−843.7 to 704.9) | 949.8 (783.7 to 1115.8) a | 1019.2 (235.2 to 1803.2) | 0.011 |
| Skeletal muscle mass index (kg/m2) | −0.02 (−0.35 to 0.32) | 0.38 (0.31 to 0.442) a | 0.40 (0.06 to 0.73) | 0.023 |
| SPPB (score) | 0.33 (0.19 to 0.46) a | 2.60 (2.23 to 2.98) a | 2.27 (1.88 to 2.68) | <0.001 |
| Chair stand test (s) | −4.44 (−5.85 to −3.03) a | 8.20 (7.05 to 9.35) a | 12.64 (10.84 to 14.44) | <0.001 |
| Timed up and go test (s) | −0.76 (−1.07 to −0.44) a | 2.95 (2.41 to 3.49) a | 3.71 (3.09 to 4.33) | <0.001 |
| Exploratory outcome variables | ||||
| Protein intake (g/day) | 4.70 (3.68 to 5.71) a | 17.18 (15.96 to 18.41) a | 12.48 (10.91 to 14.06) | <0.001 |
| Energy intake (kcal/day) | 129.2 (123.6 to 134.8) a | 182.3 (167.9 to 196. 8) a | 53.1 (37.8 to 68.5) | <0.001 |
| Mini Nutritional Assessment (score) | 0.36 (0.04 to 0.68) a | 1.88 (1.48 to 2.27) a | 1.52 (1.02 to 2.02) | <0.001 |
| C‐reactive protein (mg/dL) | 0.05 (−0.11 to 0.21) | −0.38 (−0.58 to −0.19) a | 0.43 (0.18 to 0.68) | <0.001 |
| 25‐hydroxyvitamin D (ng/mL) | 0.09 (−0.64 to 0.83) | 6.70 (5.26 to 8.14) a | 6.61 (5.00 to 8.21) | <0.001 |
| Total cholesterol (mg/dL) | −2.87 (−6.82 to 1.07) | 1.87 (−2.70 to 6.43) | 4.74 (−1.24 to 10.71) | 0.12 |
| Albumin (g/dL) | −0.14 (−0.21 to −0.07) a | 0.20 (0.15 to 0.25) a | 0.34 (0.25 to 0.43) | <0.001 |
| Creatinine (mg/dL) | −0.01 (−0.03 to 0.01) | 0.02 (0.00 to 0.05) a | 0.03 (0.00 to 0.06) | 0.031 |
Data are provided as mean and 95%CI.
Abbreviations: MMSE, Mini Mental State Examination; SF‐12 MCS, 12‐item Short Form General Health Survey‐Mental Component Summary; SF‐12 PCS, 12‐item Short Form General Health Survey‐Physical Component Summary; SPPB, Short Physical Performance Battery.
a
Within‐group change significant at the 5% level.