Table 2.
Improvement in Short Physical Performance Battery (SPPB) Score at Week-1 and Week-4 Testing
| All sample | Placebo (P) | Whey protein (W) | Rehabilitation + placebo (R + P) | Rehabilitation + protein (R + W) | Testosterone (T) | Active intervention groups (AIG) | p-Value (across groups) | p-Value (P vs. AIG) | |
|---|---|---|---|---|---|---|---|---|---|
| Results | |||||||||
| Baseline testing “n” | 100 | 20 | 20 | 21 | 20 | 19 | 80 | ||
| Total score, mean (SD) | 6.93 (3.29) | 7.75 (3.68) | 6.20 (3.09) | 7.14 (2.92) | 6.20 (3.53) | 7.37 (3.22) | 6.73 (3.29) | .46 | .22 |
| Gait speed score, mean (SD) | 2.37 (1.25) | 2.55 (1.15) | 2.05 (1.32) | 2.67 (1.32) | 2.00 (1.17) | 2.58 (1.26) | 2.33 (1.25) | .27 | .48 |
| Balance score, mean (SD) | 1.83 (1.60) | 2.30 (1.49) | 1.60 (1.67) | 1.81 (1.50) | 1.50 (1.61) | 1.95 (1.78) | 1.71 (1.60) | .92 | .51 |
| Chair rise score, mean (SD) | 2.73 (1.29) | 2.90 (1.41) | 2.55 (1.39) | 2.67 (1.28) | 2.70 (1.22) | 2.84 (1.26) | 2.69 (1.29) | .55 | 0.14 |
| Week-1 testing “n” | 93 | 19 | 18 | 19 | 19 | 18 | 74 | ||
| Total score change, mean (SD) | 1.03 (2.30) | 0.84 (1.80) | 1.33 (2.20) | 0.00 (2.26) | 1.05 (2.72) | 2.00 (2.20) | 1.08 (2.30) | .11 | .21 |
| Gait speed score change, mean (SD) | 0.40 (1.07) | 0.37 (0.83) | 0.56 (0.92) | –0.21 (1.36) | 0.58 (1.12) | 0.72 (0.89) | 0.41 (1.07) | .07 | .37 |
| Balance score change, mean (SD) | 0.28 (1.15) | 0.26 (0.56) | 0.39 (1.50) | 0.21 (0.98) | 0.05 (1.31) | 0.50 (1.25) | 0.28 (1.15) | .81 | .47 |
| Chair rise score change, mean (SD) | 0.35 (1.27) | 0.21 (1.32) | 0.39 (1.46) | 0.00 (1.00) | 0.42 (1.17) | 0.78 (1.35) | 0.39 (1.27) | .44 | .24 |
| Clinically meaningful Improvement, n (%) | 54 (58) | 8 (42) | 12 (67) | 8 (42) | 12 (63) | 14 (78) | 46 (62) | .11 | .06 |
| Week-4 testing “n” | 79 | 13 | 15 | 17 | 16 | 18 | 66 | ||
| Total score change, mean (SD) | 2.37 (2.24) | 1.31 (1.93) | 2.73 (2.28) | 2.00 (1.90) | 2.75 (2.79) | 2.83 (2.07) | 2.58 (2.24) | .29 | .03 |
| Gait speed score change, mean (SD) | 0.67 (0.89) | 0.54 (0.78) | 0.87 (0.83) | 0.47 (0.87) | 0.75 (0.86) | 0.72 (1.07) | 0.70 (0.89) | .73 | .36 |
| Balance score change, mean (SD) | 0.66 (0.14) | –0.08 (0.14) | 0.87 (0.45) | 0.71 (0.31) | 0.75 (0.31) | 0.89 (0.21) | 0.80 (0.15) | .20 | .004* |
| Chair rise score change, mean (SD) | 1.04 (0.14) | 0.85 (0.34) | 1.00 (0.29) | 0.82 (0.31) | 1.25 (0.35) | 1.22 (0.32) | 1.08 (0.16) | .81* | .32* |
| Clinically meaningful improvement, n (%) | 62 (78) | 7 (54) | 12 (80) | 14 (82) | 12 (75) | 17 (94) | 55 (83) | .10* | .01* |
| Sample size needed per group to achieve α = .05, β = .8 vs. placebo | |||||||||
| SPPB total score difference (week 4–baseline) | — | 35 | 117 | 38 | 29 | ||||
| Clinically meaningful SPPB change (≥1) | — | 64 | 64 | 64 | 64 |
Note: Change scores are improvement from baseline score *p < .05 with intention to treat analysis. All data are mean ± standard deviation or number of participants (percentage).