Table 1.
Baseline characteristics of the study population by randomization group
| Characteristic | Whole randomized population | Modified intention‐to‐treat population | ||
|---|---|---|---|---|
| Control formula (N = 70) | Experimental formula (N = 70) | Control formula (N = 63) | Experimental formula (N = 64) | |
| Male gender, N (%) | 23 (33) | 29 (41) | 17 (27) | 26 (41) |
| Age (years), Mean (SD) | 81 (5) | 80 (7) | 82 (5) | 81 (7) |
|
Admission diagnosis, N (%) Osteoarthritis Cardiovascular disease Chronic obstructive pulmonary disease Lower extremity fracture Major abdominal surgery Hypokinetic syndrome Stroke Parkinsonian syndrome |
16 (22.9) 14 (20.0) 12 (17.1) 7 (10.0) 6 (8.6) 5 (7.1) 4 (5.7) 6 (8.6) |
15 (21.5) 12 (17.1) 12 (17.1) 9 (12.9) 7 (10.0) 6 (8.6) 4 (5.7) 5 (7.1) |
14 (22.3) 14 (22.3) 10 (15.9) 7 (11.1) 6 (9.5) 4 (6.3) 4 (6.3) 4 (6.3) |
12 (18.7) 12 (18.7) 11 (17.2) 9 (14.1) 7 (10.9) 6 (9.4) 3 (4.7) 4 (6.3) |
| Comorbidities (n), Median (IQR) | 6 (4–7) | 6 (4–7) | 6 (4–7) | 6 (4–7) |
| Drugs (n), Median (IQR) | 7 (5–8) | 7 (5–8) | 7 (5–8) | 7 (5–8) |
| MMSE (score), Mean (SD) | 22.1 (2.7) | 21.8 (3.0) | 22.0 (2.7) | 21.7 (3.1) |
| Trail making test (s), Mean (SD) | 44.5 (2.9) | 45.9 (2.0) | 44.5 (2.9) | 45.9 (2.1) |
| Body weight (kg), Mean (SD) | 55.5 (9.3) | 54.0 (11.3) | 55.5 (9.2) | 54.0 (11.6) |
| Body mass index (kg/m2), Mean (SD) | 22.1 (2.3) | 21.1 (3.1) | 22.1 (2.3) | 21.0 (3.1) |
| Mini Nutritional Assessment (score), Mean (SD) | 18.0 (2.3) | 16.8 (3.1) | 18.0 (2.3) | 16.7 (3.1) |
| Appendicular muscle mass (g), Mean (SD) | 14465 (2713) | 15225.3 (3637) | 14300.6 (2613) | 15150.8 (3738) |
| Skeletal muscle mass index (kg/m2), Mean (SD) | 5.78 (0.77) | 5.90 (0.8) | 5.73 (0.75) | 5.84 (0.79) |
| 4 meter gait speed (m/s), Mean (SD) | 0.52 (0.10) | 0.54 (0.11) | 0.52 (0.09) | 0.54 (0.11) |
| Chair stand test (s), Mean (SD) | 28.6 (10.4) | 29.1 (11.8) | 29.3 (10.5) | 29.1 (12.2) |
| Timed up and go test (s), Mean (SD) | 24 (4.7) | 23.7 (4.3) | 24.0 (4.9) | 23.6 (4.3) |
| SPPB (score), Mean (SD) | 4.3 (0.8) | 4.0 (1.2) | 4.3 (0.7) | 4.1 (1.2) |
| Handgrip strength (kg), Mean (SD) | 19.1 (5.0) | 18.2 (4.1) | 18.6 (4.9) | 18.2 (4.1) |
| Tinetti scale (score), mean (SD) | 16.8 (3.7) | 17.5 (3.7) | 16.8 (3.8) | 17.6 (3.6) |
| Barthel index (score), Mean (SD) | 54.2 (18.9) | 55.2 (18.3) | 54.0 (19.3) | 55.9 (18.3) |
| Activities of daily living (score), Mean (SD) | 3.0 (1.4) | 3.1 (0.9) | 3.0 (1.4) | 3.1 (0.9) |
| SF‐12 PCS (score), Mean (SD) | 40.2 (11.1) | 38.3 (9.6) | 40.3 (11.6) | 38.4 (9.8) |
| SF‐12 MCS (score), Mean (SD) | 42.6 (10.4) | 41.6 (10.6) | 42.9 (10.9) | 42 (10.7) |
|
Rehabilitation intensity profile, Mean (SD) Profile ≥3, N (%) |
3.7 (0.5) 70 (100) |
3.6 (0.5) 70 (100) |
3.7 (0.5) 63 (100) |
3.6 (0.5) 64 (100) |
| Energy intake (kcal/day), Mean (SD) | 1154.8 (160.6) | 1097.9 (175.3) | 1144.9 (154.2) | 1095.6 (179.6) |
| Protein intake (g/day), Mean (SD) | 41.8 (7.4) | 42.8 (11.3) | 41.5 (7.1) | 42.9 (11.7) |
| Haemoglobin (g/dL), Mean (SD) | 12.8 (1.4) | 12.6 (1.2) | 12.7 (1.5) | 12.6 (1.2) |
| Total lymphocytes (n), Mean (SD) | 2.2 (0.6) | 2.3 (0.5) | 2.2 (0.6) | 2.3 (0.5) |
| Transferrin (mg/dL), Mean (SD) | 249.5 (32.4) | 249.3 (27.6) | 246.4 (30.5) | 248.8 (28) |
| Total cholesterol (mg/dL), Mean (SD) | 179.9 (29.0) | 177.2 (33.4) | 178.8 (30.2) | 176.2 (34.5) |
| Albumin (g/dL), Mean (SD) | 3.59 (0.55) | 3.6 (0.38) | 3.59 (0.55) | 3.6 (0.39) |
| Creatinine (mg/dL), Mean (SD) | 0.84 (0.21) | 0.89 (0.2) | 0.83 (0.21) | 0.89 (0.21) |
| Blood urea nitrogen (mg/dL), Mean (SD) | 34.4 (7.0) | 36.7 (6.3) | 34.4 (7.2) | 36.8 (6.5) |
| Sodium (mEq/L), Mean (SD) | 139.7 (2.8) | 139.1 (3.6) | 139.8 (2.7) | 139.1 (3.6) |
| Potassium (mEq/L), Mean (SD) | 4.2 (0.5) | 4.3 (0.6) | 4.2 (0.5) | 4.3 (0.5) |
| Calcium (mg/dL), Mean (SD) | 9.2 (0.7) | 9.2 (0.6) | 9.2 (0.6) | 9.2 (0.6) |
| Aspartate amino‐transferase (IU/L), Mean (SD) | 19.3 (7.2) | 18.1 (7.0) | 19.2 (7.5) | 18.1 (7.1) |
| Alanine amino‐transferase (IU/L), Mean (SD) | 17.5 (9.3) | 17.0 (8.1) | 17.0 (9.4) | 16.4 (8.1) |
| Blood glucose (mg/dL), Mean (SD) | 89.8 (9.2) | 86.0 (10.1) | 90.2 (9.3) | 86.3 (10.1) |
| C‐reactive protein (mg/dL), Mean (SD) | 1.29 (1.41) | 1.15 (1.38) | 1.23 (1.44) | 1.12 (1.4) |
| 25‐hydroxyvitamin D (ng/mL), Mean (SD) | 14.6 (5.6) | 14.1 (8.1) | 14.9 (5.7) | 14.4 (8.3) |
Abbreviations: IQR, interquartile range; 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; SD, standard deviation; SPPB, Short Physical Performance Battery.