Table 5 Secondary endpoints
Intervention group Median (range) | Control group Median (range) | P-values | |
|---|---|---|---|
Body Mass Index, kg/m2 | |||
Baseline (V0) | 22 .2 (18.0–45.2) (n = 33) | 23.6 (18.3–42.7) (n = 35) | 0.482 |
3 Months (V1) | 23.4 (17.3–44.8) (n = 26) | 24.4 (18.3–44.8) (n = 31) | 0.804 |
12 Months (V2) | 24.1 (18.6–46.3) n = 22) | 23.3 (18.6–46.3) (n = 27) | 0.833 |
Δ V1-V0 | −0.19 (−4.7–0.8) (n = 26) | 0.32 (−1.1–2.2) (n = 31) | 0.002 |
Δ V2-V0 | −0.16 (−7.6–2.8) (n = 22) | 0.034 (−1.9–3.6) (n = 27) | 0.115 |
EPIQ-FFQ: energy intake, kcal/day | |||
Baseline (V0) | 1955.2 (863.8–3530.5) (n = 32) | 2245.4 (1060.4–3088.3) (n = 32) | 0.045 |
3 Months (V1) | 2240.2 (800.7–3673.0) (n = 25) | 2085.8 (780.7–2965.8) (n = 29) | 0.761 |
12 Months (V2) | 2024.6 (989.0–3516.9) (n = 25) | 1936.0 (308.1–3609.9) (n = 27) | 0.405 |
Δ V1-V0 | 78.8 (−1048.1–834.1) (n = 24) | −149.4 (−741.4–653.7) (n = 28) | 0.119 |
Δ V2-V0 | 133.3 (−962.3–634.0) (n = 24) | −112.6 (−1383.2–547.8) (n = 26) | 0.007 |
EPIQ-FFQ: Fat calorie intake [%energy intake] | |||
Baseline (V0) | 40.1 (28.7–67.9) (n = 32) | 40.4 (31.4–50.0) (n = 32) | 0.968 |
3 Months (V1) | 39.4 (31.3–63.1) (n = 25) | 40.3 (30.9–60.0) (n = 29) | 0.910 |
12 Months (V2) | 40.2 (33.5–66.9) (n = 25) | 39.2 (27.1–50.6) (n = 27) | 0.504 |
Δ V1 - V0 | 0.35 (−14.32–8.38) (n = 24) | 0.49 (−11.01–15.15) (n = 28) | 0.971 |
Δ V2 - V0 | −1.30 (−6.69–26.61) (n = 24) | −2.22 (−13.16–14.25) (n = 26) | 0.367 |
MEDAS: (0–14 score points) | |||
Baseline (V0) | 7 (2–10) (n = 33) | 5 (3–11) (n = 31) | 0.020 |
3 Months (V1) | 9 (6–13) (n = 26) | 6 (3–12) (n = 29) | 0.001 |
12 Months (V2) | 8 (5–13) (n = 25) | 6 (2–13) (n = 27) | 0.001 |
Δ V1-V0 | 2 (−1–8) (n = 26) | 1 (−3–4) (n = 28) | 0.110 |
Δ V2-V0 | 2 (−2–6) (n = 25) | 0 (−3–6) (n = 25) | 0.044 |
IPAQ, MET*min/wk | |||
Baseline (V0) | 4583 (347–14,166) (n = 31) | 4215 (300–15,624) (n = 29) | 0.294 |
3 Months (V1) | 4447 (834–11,904) (n = 26) | 3230 (173–37,788) (n = 30) | 0.212 |
12 Months (V2) | 3754 (1012–11,706) (n = 24) | 4528 (189–56,943) (n = 28) | 0.463 |
Δ V1-V0 | 252 (−7961–4878) (n = 25) | −125 (−14,085–22,164) [27] | 0.654 |
Δ V2-V0 | −1878 (−10,236–6084) (n = 22) | 961 (−4178–41,310) (n = 24) | 0.004 |
VO2peak, ml/kg/min | |||
Baseline (SE-V0) | 24 (12–42) (n = 33) | 28 (15–38) (n = 35) | 0.597 |
3 Months (V1) | 26 (15–42) (n = 25) | 27 (14–40) (n = 30) | 0.993 |
12 Months (V2) | 24 (10–35) (n = 22) | 26 (14–44) (n = 23) | 0.459 |
Δ V1-V0 | 2 (−6–10) (n = 25) | 0 (−7–6) (n = 30) | 0.146 |
Δ V2-V0 | −1 (−13–11) (n = 22) | −3 (−9–6) (n = 23) | 0.045 |
O2 at VT1, ml/kg/min | |||
Baseline (SE/V0) | 14 (8–28) (n = 32) | 16 (10–28) (n = 35) | 0.281 |
3 Months (V1) | 15 (9–28) (n = 23) | 15 (10–39) (n = 30) | 0.787 |
12 Months (V2) | 14 (6–26) (n = 22) | 16 (8–28) (n = 23) | 0.068 |
Δ V1-V0 | 1 (−11–5) (n = 22) | −1.5 (−9–18) (n = 30) | 0.019 |
Δ V2-V0 | 0 (−12–8) (n = 21) | 0 (−10–7) (n = 23) | 1.000 |
QLQ-C30 scale 1 (0–100 scores) | |||
Baseline (SE/V0) | 68.7 (17–100) (n = 33) | 69.1 (33–100) (n = 35) | 0.938 |
3 Months (V1) | 69.9 (0–100) (n = 26) | 73.3 (17–100) (n = 30) | 0.569 |
12 Months (V2) | 70.1 (25–100) (n = 24) | 63.1 (8–100) (n = 26) | 0.309 |
Δ V1-V0 | 1.3 (n = 26) | 3.3 (n = 30) | 0.603 |
Δ V2-V0 | 2.1 (n = 24) | −4.8 (n = 26) | 0.267 |
SSCS (0–48 scores) | |||
Baseline (SE/V0) | 15.3 (3–38) (n = 33) | 19.5 (0–38) (n = 35) | 0.062 |
3 Months (V1) | 16.0 (3–37) (n = 26) | 18.2 (0–39) (n = 29) | 0.339 |
12 Months (V2) | 14.6 (3–41) (n = 22) | 20.9 (1–39) (n = 27) | 0.022 |
Δ V1-V0 | 0.4 (n = 26) | −0.9 (n = 29) | 0.388 |
Δ V2-V0 | −0.6 (n = 22) | 1.44 (n = 27) | 0.218 |