Table 2.
Outcomes for the intention-to-treat population according to group allocation
| FG (n = 109) | UG (n = 105) | Covariance analysis, difference between groups | Unadjusted analyses, t test, difference between groups | |||||
|---|---|---|---|---|---|---|---|---|
| N | Mean (95% CI) | N | Mean (95% CI) | Adjusted for ADT, age, and baseline score | P value | Unadjusted | P value | |
| Change in prostate cancer-specific quality of life (points; higher is better) | ||||||||
| 12 weeks | 106 | − 0.5 (− 2.6 to 1.5) | 104 | − 2.5 (− 4.6 to − 0.4) | 1.9 (− 1.0 to 4.8) | 0.20 | 2.0 (− 0.9 to 4.9) | 0.18 |
| 6 months | 100 | − 1.2 (− 3.6 to 1.2) | 100 | − 1.7 (− 4.1 to 0.6) | 0.5 (− 2.8 to 3.8) | 0.76 | 0.5 (− 2.8 to 3.9) | 0.76 |
| Change in lean body mass (kg) | ||||||||
| 6 months | 104 | − 0.2 (− 0.5 to 0.1) | 100 | − 0.1 (− 0.4 to 0.2) | − 0.1 (− 0.6 to 0.3) | 0.60 | − 0.1 (− 0.6 to 0.4) | 0.66 |
| Change in fat mass (kg) | ||||||||
| 6 months | 104 | − 0.3 (− 0.7 to 0.2) | 100 | 0.0 (− 0.4 to 0.4) | − 0.3 (− 0.9 to 0.3) | 0.28 | − 0.2 (− 0.8 to 0.3) | 0.42 |
| Change in whole-body bone mineral content (g) | ||||||||
| 6 months | 104 | 8.9 (− 5.1 to 22.8) | 100 | 4.3 (− 9.9 to 18.5) | 3.2 (− 16.9 to 23.3) | 0.75 | 4.5 (− 15.3 to 24.4) | 0.65 |
| Change in whole-body BMD (g/cm2) | ||||||||
| 6 months | 104 | 0.002 (− 0.002 to 0.007) | 100 | 0.001 (− 0.003 to 0.006) | 0.001 (− 0.006 to 0.007) | 0.87 | 0.001 (− 0.006 to 0.007) | 0.75 |
| Femoral neck BMD (g/cm2) | ||||||||
| 6 months | 104 | 0.009 (0.003 to 0.016) | 100 | 0.003 (− 0.003 to 0.009) | 0.007 (− 0.002 to 0.016) | 0.12 | 0.007 (− 0.002 to 0.016) | 0.13 |
| Change in total hip BMD (g/cm2) | ||||||||
| 6 months | 104 | 0.001 (− 0.006 to 0.008) | 100 | 0.006 (− 0.002 to 0.013) | − 0.005 (− 0.015 to 0.005) | 0.34 | − 0.004 (− 0.014 to 0.006) | 0.41 |
| Change in lumbar spine L1–L4 BMD (g/cm2) | ||||||||
| 6 months | 104 | 0.014 (0.003 to 0.025) | 99 | 0.011 (0.000 to 0.022) | 0.003 (− 0.013 to 0.019) | 0.72 | 0.003 (− 0.013 to 0.018) | 0.74 |
| Change in weekly physical activity (MET minutes) | ||||||||
| 12 weeks | 96 | 1710 (328 to 3092) | 89 | 638 (− 797 to 2073) | 698 (1158 to 2555) | 0.46 | 1072 (− 920 to 3064) | 0.29 |
| 6 months | 90 | 485 (− 759 to 1729) | 87 | 928 (− 337 to 2193) | − 754 (− 2316 to 808) | 0.34 | − 443 (− 2217 to 1332) | 0.62 |
| Change in general physical health (SF-12) | ||||||||
| 12 weeks | 106 | − 1.5 (− 2.6 to − 0.4) | 104 | − 1.7 (− 2.8 to − 0.6) | 0.1 (− 1.4 to 1.6) | 0.92 | 0.2 (− 1.3 to 1.8) | 0.79 |
| 6 months | 100 | − 2.5 (− 3.8 to − 1.2) | 100 | − 1.3 (− 2.6 to − 0.1) | − 1.1 (− 2.9 to 0.6) | 0.21 | − 1.2 (− 3.0 to 0.6) | 0.20 |
| Change in general mental health (SF-12) | ||||||||
| 12 weeks | 106 | 0.5 (− 0.8 to 1.8) | 104 | − 0.8 (− 2.1 to 0.5) | 1.5 (− 0.2 to 3.3) | 0.08 | 1.3 (− 0.5 to 3.2) | 0.15 |
| 6 months | 100 | 1.1 (− 0.4 to 2.6) | 100 | − 1.5 (− 2.9 to 0.0) | 2.7 (0.8 to 4.6) | 0.01 | 2.6 (0.5 to 4.7) | 0.02 |
Data are presented as n or mean (95% confidence interval) unless otherwise indicated
ADT androgen-deprivation therapy, BMD bone mineral density, CI confidence interval, FG football group, MET metabolic equivalent, SF-12 12-Item Short Form Health Survey, UG usual care group