Table 3

Between-group change scores from baseline for primary and secondary outcomes, modified intention-to-treat and per-protocol analyses

OutcomeModified 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 valueEffect sizeMean difference (95% CI)P valueEffect size
Primary
 6MWD, m−25.36 (−63.98 to 13.26)0.1980.2941.34 (−26.67 to 109.35)0.2320.30
Key secondary
 Accelerometry, steps per day174.49 (−1504.66 to 1853.65)0.8380.05573.98 (−1162.33 to 2310.29)0.5160.15
 Accelerometry, MVPA, min/day6.22 (−40.03 to 52.46)0.7900.07−23.38 (−75.81 to 29.05)0.3810.21
 Self-reported, IPAQ MET-min/week−317.59 (−1314.09 to 678.91)0.5320.14433.25 (−978.23 to 1844.74)0.5470.14
 Self-reported, IPAQ meeting guidelines?−7.9% (−38.0% to 22.2%)0.60817.9% (−14.0% to 49.7%)0.272
 Quadriceps force, Nm0.31 (−11.76 to 12.38)0.9600.010.89 (−13.16 to 14.95)0.9010.03
 Hand-grip strength, kg0.11 (−2.02 to 2.23)0.9230.020.39 (−3.31 to 4.08)0.8380.05
Secondary
 FACT-L total scale3.83 (−4.46 to 12.13)0.3650.2013.02 (3.94 to 22.10)0.005**0.69
 FACT-L-LCS1.92 (−0.44 to 4.28)0.1110.364.65 (1.57 to 7.74)0.003**0.72
 FACT-L-TOI4.59 (−1.70 to 10.87)0.1520.3210.42 (3.98 to 16.85)0.002**0.77
 AQoL utility score−0.02 (−0.12 to 0.09)0.770.08−0.02 (−0.16 to 0.13)0.8280.06
 MDASI-LC—symptom severity subset−0.91 (−2.15 to 0.34)0.1530.33−2.23 (−3.56 to −0.90)0.001**0.75
 MDASI-LC—symptom distress−0.61 (−1.87 to 0.65)0.3410.22−1.39 (−2.80 to 0.02)0.0540.45
 HADS anxiety−0.21 (−1.92 to 1.51)0.8150.060.24 (−1.75 to 2.23)0.8120.06
 HADS depression0.40 (−1.22 to 2.02)0.6290.11−0.95 (−2.95 to 1.05)0.3520.23
 BREQ-2—amotivation−0.30 (−0.68 to 0.08)0.1190.34−0.59 (−1.15 to −0.03)0.041*0.49
 BREQ-2—external regulation−0.11 (−0.56 to 0.33)0.6230.110.01 (−0.70 to 0.72)0.9860.01
 BREQ-2—introjected regulation−0.08 (−0.65 to 0.49)0.7820.060.48 (−0.43 to 1.39)0.2980.25
 BREQ-2—identified regulation0.41 (−0.02 to 0.85)0.0640.410.80 (0.18 to 1.42)0.012*0.62
 BREQ-2—intrinsic regulation−0.01 (−0.55 to 0.53)0.9790.010.70 (−0.10 to 1.49)0.0880.38
 PAAI4.62 (−9.72 to 18.96)0.5270.144.15 (−12.41 to 20.70)0.6220.12
 CD-RISC−1.04 (−5.21 to 3.13)0.6240.111.47 (−2.81 to 5.76)0.4990.15
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)0.3450.2352.19 (−28.40 to 132.78)0.2020.36
Key secondary
 Accelerometry, steps per day228.59 (−1635.13 to 2092.31)0.8090.06525.28 (−1498.84 to 2549.40)0.6100.14
 Accelerometry, MVPA, min/day11.34 (−41.50 to 64.17)0.6700.12−23.97 (−80.43 to 32.49)0.4040.22
 Self-reported, IPAQ MET-min/week−139.01 (−1150.71 to 872.70)0.7880.07402.48 (−1039.72 to 1844.68)0.5840.14
 Self-reported, IPAQ meeting guidelines?0.8% (−31.2% to 32.7%)0.96221.5% (−12.7% to 55.8%)0.218
 Quadriceps force, Nm1.51 (−12.94 to 15.96)0.8370.053.85 (−12.93 to 20.63)0.6520.12
 Hand-grip strength, kg0.81 (−1.08 to 2.70)0.3990.160.81 (−3.76 to 5.37)0.7280.1
  • 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.