Table 2.
Baseline | 6 Months | 12 Months | ||||||
---|---|---|---|---|---|---|---|---|
INT | CON | INT | CON | P (INT vs. CON) | INT | CON | P (INT vs. CON) | |
SBP (mmHg) ‡ | ||||||||
ITT (n = 180 vs. 89) | 134 ± 11 | 133 ± 10 | −8.6 [−11.1; −7.3] *** | −7.9 [−10.9; −5.4] *** | 0.652 | −7.3 [−9.2; −5.3] *** | −3.3 [−5.9; −0.8] * | 0.049 |
PP (n = 119 vs. 55) | 134 ± 12 | 133 ± 11 | −10.6 [−11.4; −9.6] *** | −9.9 [−13.7; −6.3] *** | 0.534 | −8.8 [−11.4; −6.1] *** | −4.0 [−7.9; −0.1] * | 0.031 |
DBP (mmHg) † | ||||||||
ITT (n = 225 vs. 117) | 94 ± 10 | 92 ± 8 | −4.6 [−5.7; −3.2] *** | −1.6 [−3.3; −0.1] * | 0.009 | −3.7 [−4.9; −2.5] *** | −1.4 [−3.1; 0.2] | 0.028 |
PP (n = 146 vs. 73) | 94 ± 9 | 92 ± 7 | −5.8 [−7.0; −4.1] *** | −2.1 [−4.1; −0.2] * | 0.003 | −4.4 [−5.8; −3.0] *** | −1.5 [−3.4; 0.5] | 0.019 |
Resting HR (bpm) $ | ||||||||
ITT (n = 208 vs. 94) | 78 ± 8 | 77 ± 8 | −4.0 [−5.3; −2.7] *** | −1.6 [−3.5; 0.4] | 0.045 | −2.7 [−4.0; −1.4] *** | −2.4 [−4.3; −0.4] * | 0.783 |
PP (n = 137 vs. 60) | 77 ± 8 | 78 ± 8 | −5.0 [−6.6; −3.4] *** | −3.6 [−6.3; −1.2] ** | 0.353 | −3.4 [−4.9; −1.6] *** | −4.5 [−6.9; −2.3] *** | 0.240 |
PWV (m/s) $ | ||||||||
ITT (n = 194 vs. 98) | 8.4 ± 0.7 | 8.2 ± 0.7 | −0.18 [−0.28; −0.08] *** | −0.07 [−0.20; 0.13] | 0.043 | −0.10 [−0.18; −0.03] * | −0.01 [−0.11; 0.10] | 0.110 |
PP (n = 137 vs. 65) | 8.3 ± 0.7 | 8.3 ± 0.8 | −0.25 [−0.36; −0.16] *** | −0.11 [−0.27; 0.15] | 0.049 | −0.09 [−0.18; 0.01] | 0.02 [−0.12; 0.16] | 0.200 |
Data are shown as mean ± SD and mean [95% CI]. *** p < 0.001 vs. baseline; ** p < 0.01 vs. baseline; * p < 0.05 vs. baseline. ‡ hypertensive and prehypertensive participants (>120 mmHg) were considered; † hypertensive and prehypertensive participants (>80 mmHg) were considered; $ upper two tertiles (with highest values); Differences in changes after 6 and 12 months between both groups were analyzed using ANCOVAs adjusting for baseline values. DBP, diastolic blood pressure; HR, heart rate; ITT, intention to treat; PP, per protocol; PWV, pulse wave velocity; SBP, systolic blood pressure.