Table 2.
Effects on Primary and Secondary End Points (Intention-to-Treat Analysis).
| AC | LET | NET | Mean Difference Between Arms | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Variable | Baseline | Week 17 | P† | Baseline | Week 17 | P† | Baseline | Week 17 | P† | LET vs. AC | P§ | NLET vs. AC | P§ | ||||
| Primary End Point | |||||||||||||||||
| VO2peak, ml O2·kg−1·min−1 | 21.8 (3.8) | 21.8 (3.7) | 0.89 | 21.5 (4.4) | 22.2 (4.6) | 0.003 | 22.2 (4.3) | 23.1 (4.8) | 0.002 | 0.6 (1.7) | 0.05 | 0.8 (1.8) | 0.07 | ||||
| Secondary End Points | |||||||||||||||||
| Resting Cardiopulmonary Function | |||||||||||||||||
| Heart rate, beats·min−1 | 77.9 (13.3) | 76.6 (11.6) | 0.34 | 75.8 (12.1) | 71.8 (9.2) | 0.001 | 75.0 (11.6) | 73.2 (12.1) | 0.06 | −2.6 (8.5) | 0.15 | −0.5 (8.6) | 0.55 | ||||
| Systolic blood pressure, mmHg | 123.4 (15.0) | 120.9 (14.7) | 0.13 | 123.6 (13.5) | 120.3 (14.2) | 0.04 | 119.5 (14.0) | 116.0 (14.6) | 0.06 | −0.7 (11.4) | 0.55 | −1.0 (12.3) | 0.52 | ||||
| Diastolic blood pressure, mmHg | 75.4 (8.1) | 73.2 (8.7) | 0.04 | 74.1 (9.7) | 72.0 (7.8) | 0.05 | 74.7 (8.2) | 71.1 (8.9) | <0.001 | 0.2 (8.5) | 0.85 | −1.4 (7.9) | 0.25 | ||||
| Peak Cardiopulmonary Function | |||||||||||||||||
| VO2peak, ml O2·min−1 | 1684.6 (299.5) | 1693.3 (314.7) | 0.66 | 1714.6 (330.0) | 1762.1 (369.2) | 0.005 | 1735.9 (377.7) | 1778.9 (378.8) | 0.05 | 38.0 (129.0) | 0.13 | 34.2 (154.0) | 0.27 | ||||
| RER | 1.1 (0.1) | 1.1 (0.1) | 0.82 | 1.1 (0.1) | 1.1 (0.1) | 0.12 | 1.1 (0.1) | 1.1 (0.1) | 0.88 | 0.0 (0.1) | 0.29 | 0.0 (0.1) | 0.85 | ||||
| Ventilation, L O2·min−1 | 62.8 (14.2) | 62.5 (12.7) | 0.60 | 64.1 (14.5) | 63.5 (14.0) | 0.41 | 65.4 (14.1) | 65.9 (13.7) | 0.68 | −0.3 (6.4) | 0.61 | 0.7 (7.1) | 0.57 | ||||
| Heart rate, beats·min−1 | 162.2 (17.8) | 160.9 (18.9) | 0.35 | 161.5 (15.0) | 156.6 (16.0) | <0.001 | 165.2 (16.3) | 163.9 (17.1) | 0.20 | −3.5 (10.1) | 0.06 | 0.0 (8.5) | 0.59 | ||||
| Systolic blood pressure, mmHg | 174.4 (22.3) | 176.6 (22.4) | 0.51 | 175.5 (18.5) | 175.5 (22.3) | 0.81 | 172.9 (22.1) | 176.2 (23.6) | 0.39 | −1.5 (12.4) | 0.92 | 0.7 (13.8) | 0.65 | ||||
| Diastolic blood pressure, mmHg | 68.2 (10.1) | 70.9 (10.7) | 0.07 | 70.7 (11.7) | 69.8 (13.0) | 0.57 | 70.8 (11.3) | 71.9 (11.0) | 0.66 | −2.3 (7.5) | 0.04 | −1.1 (8.0) | 0.12 | ||||
| FACT-B Total (0–140) | 107.6 (16.3) | 108.9 (16.2) | 0.31 | 104.8 (17.2) | 107.8 (20.7) | 0.05 | 111.6 (14.1) | 116.7 (14.0) | <0.001 | 1.7 (10.4) | 0.22 | 3.7 (7.7) | 0.005 | ||||
| FACT-G Total (0–108) | 87.6 (13.5) | 88.4 (13.6) | 0.49 | 85.3 (13.6) | 87.1 (16.8) | 0.11 | 90.33 (11.6) | 93.8 (11.3) | <0.001 | 1.0 (9.1) | 0.27 | 2.6 (6.7) | 0.02 | ||||
| FACIT-Fatigue (0–52) | 39.6 (10.9) | 39.9 (10.7) | 0.36 | 36.7 (11.9) | 39.5 (12.2) | 0.002 | 42.8 (8.9) | 44.8 (9.0) | 0.01 | 2.5 (7.8) | 0.001 | 1.7 (6.5) | 0.01 | ||||
Data presented as mean (SD)
†
Paired Wilcoxon Signed Rank p-value for change within group from baseline to week 17
§
Wilcoxon Rank Sum p-value for delta change between groups from baseline to week 17.
Abbreviations: AC, attention control; LET, standard linear exercise training; NLET, non-linear exercise training; VO2peak, peak oxygen consumption; FACT, Functional Assessment of Cancer Therapy, FACIT, Functional Assessment of Chronic Illness Therapy.