Table 2.
Primary and secondary outcomes.
Baseline, n | Post-NCT, n | Pre-surgery, n | Post-surgery, n | 6-Week reassessment, n | Diff-in-diff baseline to pre-surgery, P value (95% CI EX; UC) | Diff-in-diff post-surgery to 6 weeks, P value (95% CI EX; UC) | |
---|---|---|---|---|---|---|---|
Primary outcome | |||||||
6 min walk test (m) | |||||||
Exercise | 522.1 (104.3), 36 | 543.4 (108.7), 30 | 582.1 (108), 29 | 498.3 (99.5), 28 | 578.3 (104.7), 22 | 50.7, 0.05 (38.3–85.8; −8.5 to 48.0) | 31.8, 0.19 (18.5–85.6; 0.5–76.8) |
Control | 497.5 (106.3), 34 | 511.2 (172), 19 | 506.0 (140.4), 24 | 515.0 (91.5), 17 | 547.6 (99.5), 17 | ||
Secondary outcomes: Physical health | |||||||
Handy dynamometer (kg) | |||||||
Exercise | 31.1 (8.2), 34 | 31.1 (7.1), 22 | 28.2 (8.5), 23 | 28.0 (9.6), 11 | 31.6 (10.6), 6 | 0.4, 0.77 | −2.3, 0.23 |
Control | 30.6 (9.1), 32 | 26.1 (7.9), 12 | 25.1 (8.7), 15 | 25.0 (8.5), 11 | 26.9 (9.1), 8 | (−5.1 to −1.3; −5.5 to −0.7) | (−1.4 to 3.4; −0.4 to 4.9) |
Lower body strength (s) | |||||||
Exercise | 18.2 (5.7), 36 | 17.7 (7.7), 29 | 15.5 (5.1), 28 | 17.9 (7.7), 26 | 15.3 (7.5), 22 | −2.5, 0.08 | −0.4, 0.80 |
Control | 19.6 (7.2), 33 | 20.6 (8), 19 | 20.1 (6.7), 24 | 20.4 (5.1), 17 | 19.3 (5.3), 17 | (−4.5 to −0.9; −2.6 to 3.0) | (−6.5 to 0.7; −3.4 to 1.1) |
Activity behaviour: Daily step count | |||||||
Exercise | 7175.1 (4024.6), 29 | 6692.5 (3363.7), 25 | 7420.3 (4762.2), 19 | 5873.6 (3676.1), 21 | 5954.6 (3027), 21 | −63.4, 0.95 (−1106 to 2495; −1409 to 1799) | −711.6, 0.50 (−1698 to 2296; −231 to 1769) |
Control | 6589.9 (4014.8), 27 | 5802.9 (3299.5), 19 | 7206.3 (2831.6), 19 | 6371.0 (3775.5), 18 | 6871.7 (4120.9), 17 | ||
Sedentary behaviour (h) | |||||||
Exercise | 19.1 (1.9), 29 | 19.8 (1.6), 25 | 18.4 (2.2), 19 | 20.0 (1.4), 21 | 19.7 (1.5), 21 | 0.7, 0.44 | 0.3, 0.61 |
Control | 19.4 (2.3), 27 | 19.3 (1.9), 19 | 17.9 (3.2), 19 | 19.5 (2.1), 18 | 18.8 (2.5), 17 | (−1.4 to 0.9; −3.7 to 1.1) | (−1.1 to 0.6;−0.5 to 0.2) |
Body mass index (kg/m2) | |||||||
Exercise | 27.9 (5.5), 33 | 26.9 (4.3), 27 | 27.1 (5), 27 | 26.4 (4.7), 24 | 25.1 (4), 16 | −0.3, 0.77 | −0.7, 0.85 |
Control | 27.7 (4.5), 30 | 26.4 (5.3),16 | 26.4 (4.9),,25 | 24.2 (4.3),,15 | 22.8 (2.4),,11 | (−1.7 to 0.4; −1.8 to 0.1) | (−1.1 to 0.4; −1.7 to −0.2) |
Psychological health: EQ-5D Questionnaire | |||||||
EQ-Utility | |||||||
Exercise | 0.897 (0.165), 36 | 0.902 (0.132), 31 | 0.920 (0.119), 29 | 0.801 (0.172), 27 | 0.872 (0.113), 23 | 0.045, 0.27 (−0.1 to 0.0; −0.1 to 0.0) | 0.05, 0.23 (0.0–0.1; −0.1 to 0.2) |
Control | 0.909 (0.115), 34 | 0.902 (0.122), 19 | 0.894 (0.128), 28 | 0.887 (0.103), 20 | 0.883 (0.158), 20 | ||
EQ-VAS | |||||||
Exercise | 78.8 (16.6), 36 | 76.7 (15.4), 31 | 83.6 (14.5), 29 | 70.4 (13.5), 27 | 76.6 (14.7), 23 | 5.4, 0.21 (−1.6 to 12.0; −8.1 to 3.6) | −1.2, 0.77 (−1.2 to 19.2; 3.4–12.5) |
Control | 76.9 (19.2), 34 | 71.6 (19.2), 19 | 78.3 (15), 28 | 71.8 (15.2), 20 | 78.8 (11.8), 20 | ||
FACT Questionnaire Total Score (0–176-best) | |||||||
Exercise | 139.4 (17.2), 34 | 141.1 (17.4), 31 | 152.2 (16.2), 29 | 137.8 (14.9), 27 | 142.6 (19.5), 23 | 4.9, 0.23 (6.2–18.2; 0.4–18.8) | −0.5, 0.91 (−2.8 to 13.3; 12.7–13.1) |
Control | 141.0 (22.8), 32 | 138.6 (27.1), 17 | 147.8 (25.4), 27 | 143.0 (20.5), 20 | 144.3 (16.1), 19 | ||
FACT Physical well-being (0–28-best) | |||||||
Exercise | 23.9 (4.2), 36 | 21.2 (5.4), 31 | 25.2 (3.7), 29 | 21.0 (4.2), 27 | 21.8 (5.6), 23 | 2.2, 0.08 | 0.1, 0.95 |
Control | 23.6 (4.9), 34 | 18.8 (7.9), 19 | 22.6 (7.1), 28 | 21.6 (4.9), 20 | 21.9 (5), 20 | (−0.6 to 2.9; −2.2 to 0.7) | (−1.9 to 2.4; −1.2 to 2.4) |
FACT Social/family well-being (0–28-best) | |||||||
Exercise | 26.3 (2.6), 36 | 25.5 (4.1), 31 | 25.6 (4.1), 29 | 26.2 (3.6), 27 | 26.0 (3.8), 23 | 0.2, 0.86 | −0.6, 0.40 |
Control | 27.0 (2), 34 | 26.9 (1.5), 19 | 26.1 (2.9), 28 | 26.8 (2.7), 20 | 27.2 (1.3), 20 | (−1.2 to 0.8; −2.6 to 0.4) | (−1.2 to 0.5; −1.4 to 1.7) |
FACT Emotional well-being (0–24-best) | |||||||
Exercise | 19.1 (4.7), 36 | 20.2 (3), 31 | 19.5 (4.1), 29 | 20.5 (3), 27 | 20.9 (3.3), 23 | −0.7, 0.38 | 0.1, 0.92 |
Control | 18.5 (4.7), 34 | 20.9 (3), 19 | 19.4 (3.6), 28 | 20.8 (4.3), 20 | 21.0 (3.3), 20 | (−0.8 to 1.2; −0.1 to 2.4) | (−1.1 to 2.5; −1.4 to 1.8) |
FACT Functional well-being (0–28-best) | |||||||
Exercise | 21.2 (6.2), 36 | 21.6 (4.4), 31 | 22.6 (4.9), 29 | 18.4 (5.5), 27 | 20.0 (4.5), 23 | 1.5, 0.25 | −0.7, 0.59 |
Control | 22.1 (6), 34 | 18.6 (7.2), 19 | 21.8 (6.1), 28 | 20.9 (5.5), 20 | 21.8 (4.9), 19 | (−1.0 to 3.2; −2.1 to 1.4) | (−1.0 to 2.77; 0.5–3.7) |
FACT Additional concerns (0–68-best) | |||||||
Exercise | 49.4 (10.2), 34 | 52.7 (9.7), 31 | 59.3 (7.5), 29 | 51.7 (6.3), 27 | 53.9 (7.5), 23 | 2.0, 0.47 | 0.7, 0.75 |
Control | 49.4 (13), 32 | 52.5 (13.6), 17 | 57.8 (12.5), 27 | 52.9 (8.8), 20 | 53.0 (7.3), 20 | (5.9–14.3; 3.7–12.7) | (0.3–4.4; −3.6 to 6.4) |
Surgical Fear Questionnaire | |||||||
Surgical fear Short-term (0–40-very afraid) | |||||||
Exercise | 12.5 (10.1), 36 | 13.3 (10.1), 31 | 11.9 (11.7), 30 | — | — | −1.5, 0.50 | — |
Control | 9.7 (9.7), 35 | 10.0 (9.1), 20 | 10.1 (10.6), 28 | (−4.0 to 2.4; −1.7 to 6.7) | |||
Surgical fear Long-term (0–40-very afraid) | |||||||
Exercise | 17.8 (14.1),6 | 16.6 (14.1),1 | 15.2 (13.9),0 | — | — | −2.0, 0.45 | — |
Control | 13.1 (12.1), 35 | 14.3 (13.3), 20 | 12.3 (13.8), 28 | (−4.3 to 0.5; −2.7 to 2.5) | |||
Surgical fear Overall (0–80-very afraid) | |||||||
Exercise | 30.3 (23.1), 36 | 29.9 (23.3), 31 | 27.1 (24), 30 | — | — | −3.6, 0.43 | — |
Control | 22.8 (19.5), 35 | 24.3 (21), 20 | 22.4 (22.2), 28 | (−7.8 to 2.5; −3.7 to 8.5) | |||
General Self-efficacy (0–40-best) | |||||||
Exercise | 34.4 (4.5), 34 | 34.1 (4.8), 31 | 34.9 (4.1), 29 | 34.5 (3.9), 27 | 35.7 (4), 23 | 1.3, 0.20 | −0.0, 0.99 |
Control | 35.1 (4.2), 34 | 33.5 (5.5), 17 | 34.3 (4.5), 27 | 34.5 (4.9), 20 | 35.0 (4.2), 20 | (−0.7 to 2.2; −2.4 to 0.9) | (−0.3 to 2.3; −0.7 to 2.8) |
Pearlin Mastery Scale (7–48-best) | |||||||
Exercise | 30.5 (8.2), 36 | 32.4 (7), 31 | 30.9 (6.1), 29 | 33.6 (6.9), 27 | 33.7 (5.3), 23 | 1.3, 0.55 | −3.0, 0.18 |
Control | 31.4 (6.3), 34 | 30.4 (7.3), 19 | 29.9 (8.3), 28 | 30.6 (7.4), 20 | 33.5 (6.2), 20 | (−3.5 to 1.9; −4.5 to 2.9) | (−3.8 to 2.4; −1.1 to 6.6) |