Background
Methods
Study design
Statistical analysis
Results
Baseline characteristics
Intervention group
n = 33 | Control group
n = 35 | Total
n = 68 |
P-value | |
---|---|---|---|---|
Cancer, n - Breast, n - Ovarian, n - both, n | 23 21 1 1 | 23 22 1 0 | 46 43 2 1 | 0.728 |
BRCA-1 / -2, n | 24 / 9 | 18 / 17 | 42 / 26 | 0.073 |
Agea, yrs | 41 (27–72) | 41 (24–68) | 41 (24–72) | 0.839 |
BMIa, kg/m2
| 22.2 (18.0–45.4) | 23.6 (18.3–42.2) | 23.2 (18.0–45.4) | 0.482 |
VO2peaka, ml/kg/min | 24 (12–42) | 28 (15–38) | 26 (12–42) | 0.597 |
Drop-out, n | 7 | 6 | 13 | 0.672 |
Feasibility outcomes
Completion of the study
Drop-outs | Intervention group n = 7 | Control group n = 6 | Total n = 13 |
P-value |
---|---|---|---|---|
Drop-out period, n | 0.945 | |||
- Months 1–3 - Months 4–12 | 5 2 | 4 2 | 9 4 | |
Reason, n | 0.445 | |||
- Motivation-related - Disease-related | 4 3 | 5 1 | 9 4 | |
Cancer, n | 5 | 4 | 9 | 0.945 |
Agea, years | 45 (30–51) | 34 (26–46) | 39 (26–51) | 0.138 |
BMIa, kg/m2
| 20.9 (19.8–26.9) | 23.7 (20.7–38.6) | 23.1 (19.8–38.6) | 0.138 |
VO2peaka, ml/kg/min | 30 (20–32) | 24.5 (16–34) | 26 (16–34) | 0.543 |
O2 at VT1a, ml/kg/min | 14 (9–19) | 13.5 (10–25) | 14 (9–25) | 0.731 |
IPAQ, METamin/wk | 3366 (1552–12,561) | 9750 (4278–14,085) | 3990 (1552–14,085) | 0.042 |
Adherence to intervention
Adherence positive (≥ 70% participation in the intervention sessions) | Adherence negative (< 70% participation in the intervention sessions) |
P-value | |
---|---|---|---|
Nutrition courses | 21/26 (81%) | 5/26 (19%) | |
Cancer, n | 16 | 2 | 0.610 |
Age*, years | 43 (29–72) | 41 (28–49) | 0.686 |
BMI*, kg/m2
| 23 (18–45) | 24 (20–37) | 0.610 |
VO2peak*, ml/kg/min | 24 (12–42) | 23 (16–41) | 0.952 |
O2 at VT1*, ml/kg/min | 14 (8–28) | 14 (10–21) | 0.343 |
IPAQ, MET*min/wk | 5130 (347–14,166) | 6167 (4583–7812) | 0.629 |
Training courses | 21/26 (81%) | 5/26 (19%) | |
Cancer, n | 14 | 4 | 0.114 |
Age*, years | 42 (28–72) | 41 (36–51) | 0.286 |
BMI*, kg/m2
| 23 (18–45) | 24 (20–37) | 0.857 |
VO2peak*, ml/kg/min | 24 (12–42) | 22 (16–37) | 0.467 |
O2 at VT1*, ml/kg/min | 14 (8–28) | 15 (10–21) | 1.000 |
IPAQ, MET*min/wk | 5376 (347–14,166) | 5375 (2826–7812) | 0.970 |
Nutrition and training | 19/26 (73%) | 7/26 (27%) | |
Cancer, n | 14 | 4 | 0.534 |
Age*, years | 43 (29–27) | 41 (28–51) | 0.821 |
BMI*, kg/m2
| 23 (18–45) | 24 (20–37) | 0.778 |
VO2peak*, ml/kg/min | 24 (12–42) | 23 (16–41) | 0.955 |
O2 at VT1*, ml/kg/min | 14 (8–28) | 15 (10–21) | 0.642 |
IPAQ, MET*min/wk | 5376 (347–14,166) | 5576 (2826–7812) | 0.974 |
Recruitment and retention
Adverse events and safety
Satisfaction with the study
Rate of return | Intervention group 69% (18/26) | Control group 76% (22/29) |
P-value | ||||
---|---|---|---|---|---|---|---|
Items | “Good” Grading 1–2 | “Inter-mediate” Grading 3–4 | “Bad” Grading 5–6 | “Good” Grading 1–2 | “Inter-mediate” Grading 3–4 | “Bad” Grading 5–6 | |
Overall satisfaction with the study and care | 15 (83%) | 3 (17%) | 0 (0%) | 14 (64%) | 7 (32%) | 1 (4.5%) | 0.096 |
Extent and feasibility of physical intervention (IG) | 10 (56%) | 5 (28%) | 3 (17%) | not asked | |||
Extent and feasibility of nutritional intervention (IG) | 14 (78%) | 4 (22%) | 0 (0%) | not asked | |||
Extent and feasibility of general information on training and healthy eating (CG) | not asked | 9 (41%) | 10 (45%) | 2 (9%) | |||
yes | No | yes | no |
p-value | |||
Willingness to partake in such studies again | 15 (83%) | 3 (17%) | 17 (77%) | 5 (23%) | 0.683 |
Secondary outcome measurements
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 |