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Table 5 Secondary endpoints

From: Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers – an interventional randomized controlled multicenter trial (LIBRE-1)

  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
  1. *Median (Range)
  2. Bold = significant P-values