Outcome | Modified intention-to-treat, imputed data | |||||
9 weeks, n=78 (40 UC, 38 IG) | 6 months, n=70 (36 UC, 34 IG) | |||||
Mean difference (95% CI) | P value | Effect size | Mean difference (95% CI) | P value | Effect size | |
Primary | ||||||
6MWD, m | −25.36 (−63.98 to 13.26) | 0.198 | 0.29 | 41.34 (−26.67 to 109.35) | 0.232 | 0.30 |
Key secondary | ||||||
Accelerometry, steps per day | 174.49 (−1504.66 to 1853.65) | 0.838 | 0.05 | 573.98 (−1162.33 to 2310.29) | 0.516 | 0.15 |
Accelerometry, MVPA, min/day | 6.22 (−40.03 to 52.46) | 0.790 | 0.07 | −23.38 (−75.81 to 29.05) | 0.381 | 0.21 |
Self-reported, IPAQ MET-min/week | −317.59 (−1314.09 to 678.91) | 0.532 | 0.14 | 433.25 (−978.23 to 1844.74) | 0.547 | 0.14 |
Self-reported, IPAQ meeting guidelines? | −7.9% (−38.0% to 22.2%) | 0.608 | 17.9% (−14.0% to 49.7%) | 0.272 | ||
Quadriceps force, Nm | 0.31 (−11.76 to 12.38) | 0.960 | 0.01 | 0.89 (−13.16 to 14.95) | 0.901 | 0.03 |
Hand-grip strength, kg | 0.11 (−2.02 to 2.23) | 0.923 | 0.02 | 0.39 (−3.31 to 4.08) | 0.838 | 0.05 |
Secondary | ||||||
FACT-L total scale | 3.83 (−4.46 to 12.13) | 0.365 | 0.20 | 13.02 (3.94 to 22.10) | 0.005** | 0.69 |
FACT-L-LCS | 1.92 (−0.44 to 4.28) | 0.111 | 0.36 | 4.65 (1.57 to 7.74) | 0.003** | 0.72 |
FACT-L-TOI | 4.59 (−1.70 to 10.87) | 0.152 | 0.32 | 10.42 (3.98 to 16.85) | 0.002** | 0.77 |
AQoL utility score | −0.02 (−0.12 to 0.09) | 0.77 | 0.08 | −0.02 (−0.16 to 0.13) | 0.828 | 0.06 |
MDASI-LC—symptom severity subset | −0.91 (−2.15 to 0.34) | 0.153 | 0.33 | −2.23 (−3.56 to −0.90) | 0.001** | 0.75 |
MDASI-LC—symptom distress | −0.61 (−1.87 to 0.65) | 0.341 | 0.22 | −1.39 (−2.80 to 0.02) | 0.054 | 0.45 |
HADS anxiety | −0.21 (−1.92 to 1.51) | 0.815 | 0.06 | 0.24 (−1.75 to 2.23) | 0.812 | 0.06 |
HADS depression | 0.40 (−1.22 to 2.02) | 0.629 | 0.11 | −0.95 (−2.95 to 1.05) | 0.352 | 0.23 |
BREQ-2—amotivation | −0.30 (−0.68 to 0.08) | 0.119 | 0.34 | −0.59 (−1.15 to −0.03) | 0.041* | 0.49 |
BREQ-2—external regulation | −0.11 (−0.56 to 0.33) | 0.623 | 0.11 | 0.01 (−0.70 to 0.72) | 0.986 | 0.01 |
BREQ-2—introjected regulation | −0.08 (−0.65 to 0.49) | 0.782 | 0.06 | 0.48 (−0.43 to 1.39) | 0.298 | 0.25 |
BREQ-2—identified regulation | 0.41 (−0.02 to 0.85) | 0.064 | 0.41 | 0.80 (0.18 to 1.42) | 0.012* | 0.62 |
BREQ-2—intrinsic regulation | −0.01 (−0.55 to 0.53) | 0.979 | 0.01 | 0.70 (−0.10 to 1.49) | 0.088 | 0.38 |
PAAI | 4.62 (−9.72 to 18.96) | 0.527 | 0.14 | 4.15 (−12.41 to 20.70) | 0.622 | 0.12 |
CD-RISC | −1.04 (−5.21 to 3.13) | 0.624 | 0.11 | 1.47 (−2.81 to 5.76) | 0.499 | 0.15 |
Per-protocol, imputed data | ||||||
9 weeks, n=66 (40 UC, 26 IG) | 6 months, n=59 (36 UC, 23 IG) | |||||
Primary | ||||||
6MWD, m | −17.89 (−55.03 to 19.25) | 0.345 | 0.23 | 52.19 (−28.40 to 132.78) | 0.202 | 0.36 |
Key secondary | ||||||
Accelerometry, steps per day | 228.59 (−1635.13 to 2092.31) | 0.809 | 0.06 | 525.28 (−1498.84 to 2549.40) | 0.610 | 0.14 |
Accelerometry, MVPA, min/day | 11.34 (−41.50 to 64.17) | 0.670 | 0.12 | −23.97 (−80.43 to 32.49) | 0.404 | 0.22 |
Self-reported, IPAQ MET-min/week | −139.01 (−1150.71 to 872.70) | 0.788 | 0.07 | 402.48 (−1039.72 to 1844.68) | 0.584 | 0.14 |
Self-reported, IPAQ meeting guidelines? | 0.8% (−31.2% to 32.7%) | 0.962 | 21.5% (−12.7% to 55.8%) | 0.218 | ||
Quadriceps force, Nm | 1.51 (−12.94 to 15.96) | 0.837 | 0.05 | 3.85 (−12.93 to 20.63) | 0.652 | 0.12 |
Hand-grip strength, kg | 0.81 (−1.08 to 2.70) | 0.399 | 0.16 | 0.81 (−3.76 to 5.37) | 0.728 | 0.1 |
Mean differences are intervention group minus usual care. P values were calculated by two-sample independent t-tests. *p<0.05, **p<0.005. Cohen’s d effect size (mean diff IG–mean diff UC)/pooled SD; small=0.2, moderate=0.5, large=0.80.
AQoL utility score, Assessment of Quality of Life utility score; BREQ-2, Behavioural Regulation in Exercise Questionnaire, version 2, lower amotivation subscale scores indicate reduced levels of amotivation; CD-RISC, Connor-Davidson Resilience Scale; FACT-L LCS, Lung Cancer Subscale; FACT-L TOI, Trial Outcome Index; FACT-L scale, Functional Assessment of Cancer Therapy–Lung; HADS, Hospital Anxiety and Depression Scale, lower scores indicate improved mood; IPAQ, International Physical Activity Questionnaire; MDASI-LC, MD Anderson Symptom Inventory–Lung Cancer (symptom severity subset defined a priori including drowsiness, fatigue, sleep disturbance, shortness of breath and pain), lower scores indicate improved symptom severity and distress; MET, metabolic equivalent of task; MVPA, moderate-to-vigorous physical activity; 6MWD, 6 min walk distance; Nm, Newton metres; PAAI, Physical Activity Assessment Inventory.