Table 2.
Effects of the EFFECT exercise program on HRQOL, fatigue, physical fitness and activity outcomes
| BGDs at 3 months | BGDs at 6 months | BGDs at 9 months | |||||
|---|---|---|---|---|---|---|---|
| Mean (95% CI) | ES | Mean (95% CI) | ES | Mean (95% CI) | ES | ||
| Primary outcomes | |||||||
| Summary score (EORTC QLQ-C30) | EX vs CG | 3.9 (1.5–6.3)* | 0.27 | 4.8 (2.2–7.4)* | 0.33 | 4.3 (1.4–7.3)* | 0.30 |
| Physical fatigue (EORTC QLQ-FA12) | EX vs CG | −3.4 (−7.8–1.0) | 0.14 | −5.3 (−10.0 to −0.6)* | 0.22 | −5.6 (−10.9 to −0.4)* | 0.24 |
| Sensitivity analysis | |||||||
| Multiple imputation | |||||||
| Summary score | EX vs CG | 4.4 (1.7–7.2)* | 0.31 | 4.8 (2.3–7.3)* | 0.33 | 4.4 (1.7–7.2)* | 0.31 |
| Physical fatigue | EX vs CG | −3.9 (−8.2–0.3) | 0.16 | −5.6 (−10.1 to −1.0)* | 0.24 | −5.6 (−10.7 to −0.6)* | 0.24 |
| EORTC QLQ-C30 | |||||||
| Global QOL | EX vs CG | 2.6 (−1.1–6.4) | 0.15 | 4.7 (0.8–8.7)* | 0.27 | 4.5 (0.3–8.6)* | 0.25 |
| Physical functioning | EX vs CG | 3.9 (0.8–6.9)* | 0.23 | 7.0 (3.6–10.3)* | 0.42 | 5.9 (2.2–9.6)* | 0.33 |
| Physical functioning T-scorea | EX vs CG | 2.5 (1.3–3.8)* | 0.34 | 3.2 (1.8–4.7)* | 0.43 | 3.0 (1.3–4.7)* | 0.40 |
| Emotional functioning | EX vs CG | −0.2 (−4.3–3.8) | 0.01 | 0.8 (−3.3–4.9) | 0.03 | 0.9 (−3.6–5.3) | 0.04 |
| Role functioning | EX vs CG | 5.1 (−0.2–10.5) | 0.20 | 7.6 (2.1–13.1)*# | 0.29 | 5.0 (−1.1–11.1) | 0.19 |
| Social functioning | EX vs CG | 4.0 (−1.0–8.9) | 0.14 | 5.5 (0.2–10.8)* | 0.20 | 8.9 (3.1–14.6)*# | 0.32 |
| Cognitive functioning | EX vs CG | 4.0 (0.4–7.5)* | 0.16 | 3.5 (−0.3–7.2) | 0.14 | 2.5 (−1.5–6.6) | 0.10 |
| Fatigue | EX vs CG | −5.4 (−9.8 to −1.0)* | 0.22 | −8.0 (−12.7 to −3.4)*# | 0.32 | −6.4 (−11.6 to −1.2)* | 0.26 |
| Pain | EX vs CG | −4.9 (−9.8 to −0.03)* | 0.20 | −7.1 (−12.1 to −1.9)* | 0.28 | −6.5 (−12.0 to −1.0)* | 0.26 |
| Nausea and vomiting | EX vs CG | −0.6 (−3.4–2.2) | 0.04 | −2.4 (−5.5–0.7) | 0.18 | −2.5 (−6.1–1.0) | 0.19 |
| Dyspnea | EX vs CG | −4.1 (−8.6–0.3) | 0.16 | −7.6 (−12.2 to −3.0)* | 0.28 | −3.9 (−9.0–1.3) | 0.14 |
| Insomnia | EX vs CG | −5.7 (−11.1 to −0.2)* | 0.19 | −4.7 (−10.7–1.3) | 0.16 | −4.4 (−10.9–2.1) | 0.15 |
| Appetite loss | EX vs CG | −1.9 (−6.8–3.1) | 0.08 | −3.9 (−8.7–1.0) | 0.17 | −3.8 (−8.9–1.2) | 0.16 |
| Constipation | EX vs CG | −4.7 (−9.3–0.04) | 0.18 | 0.3 (−4.5–5.1) | 0.01 | −0.6 (−6.2–4.9) | 0.03 |
| Diarrhea | EX vs CG | −2.3 (−6.9–2.3) | 0.09 | −0.4 (−5.2–4.4) | 0.02 | −1.8 (−6.9–3.2) | 0.07 |
| Financial difficulties | EX vs CG | −1.9 (−6.1–2.3) | 0.07 | −1.1 (−5.6–3.4) | 0.04 | −1.6 (−6.4–3.2) | 0.06 |
| EORTC QLQ-FA12 | |||||||
| Emotional fatigue | EX vs CG | 1.3 (−3.3–5.8) | 0.05 | −3.2 (−8.1–1.7) | 0.13 | −1.1 (−6.3–4.1) | 0.05 |
| Cognitive fatigue | EX vs CG | −1.1 (−4.6–2.3) | 0.06 | −2.4 (−5.7–0.9) | 0.12 | −1.5 (−5.0–1.9) | 0.08 |
| Interference with daily activities | EX vs CG | −1.1 (−6.9–4.6) | 0.04 | −5.0 (−10.8–0.8) | 0.19 | −4.8 (−10.8–1.1) | 0.18 |
| Social sequelae | EX vs CG | −2.6 (−7.0–1.9) | 0.11 | −2.4 (−7.1–2.2) | 0.10 | −5.1 (−10.0 to −0.1)* | 0.21 |
| Physical fitness | |||||||
| MSEC (W) | EX vs CG | 23.2 (15.8–30.6)* | 0.44 | 24.8 (17.3–32.3)* | 0.47 | Not tested | Not tested |
| Self-reported physical activity (Godin–Shephard Leisure-Time Exercise Questionnaire) | |||||||
| Aerobic exercise | |||||||
| Vigorous intensity (min per week) | EX vs CG | 23 (14–33)* | 0.73 | 24 (15–33)* | 0.77 | 15 (5–24)* | 0.48 |
| Moderate intensity (min per week) | EX vs CG | 19 (−2–41) | 0.24 | 2 (−20–23) | 0.02 | 28 (7–49)* | 0.35 |
| Light intensity (min per week) | EX vs CG | −21 (−59–18) | 0.13 | −6 (−44–32) | 0.04 | −14 (−57–29) | 0.08 |
| Resistance exercise (min per week) | EX vs CG | 30 (19–41)* | 1.17 | 38 (27–49)* | 1.49 | 16 (5–26)* | 0.63 |
| Measured physical activity using the Fitbit Inspire HRb | |||||||
| Steps per day | EX vs CG | 261 (−590–1,111) | 0.05 | 682 (−232–1,597) | 0.14 | 761 (−378–1,899) | 0.16 |
| Sedentary (min per day) | EX vs CG | −39 (−102–24) | 0.15 | −65 (−135–5) | 0.24 | −85 (−166 to −4)* | 0.32 |
| Lightly active (min per day) | EX vs CG | 13 (−9–34) | 0.15 | 14 (−10–37) | 0.17 | 10 (−18–38) | 0.12 |
| Fairly active (min per day) | EX vs CG | −0.4 (−5–4) | 0.03 | 0.6 (−4–5) | 0.04 | 5 (−0.2–10) | 0.32 |
| Very active (min per day) | EX vs CG | 2 (−2–6) | 0.10 | 7 (2–12)* | 0.36 | 7 (1–13)* | 0.36 |
Models were adjusted for the baseline value of the outcome and stratification factors (that is, center and therapy line) and included participants for whom the outcome was observed at two or more timepoints. Suggested interpretation by Cohen: ES < 0.2, no difference; ES of 0.2–0.5, small difference; ES of 0.5–0.8, medium difference; ES ≥ 0.8, large difference. *Indicates significant differences (P < 0.05). Significant BGDs are in bold. #Indicates that the BGD is larger than the MID, which has been estimated in patients with advanced breast cancer and can be interpreted as the smallest change in a HRQOL outcome that is perceived as important by a patient28. The following MIDs have been established and are only available to EORTC QLQ-C30 symptom and functional scales: 8 (physical functioning), 4 (role functioning), 7 (social functioning), 4 (cognitive functioning), 10 (global QOL) and 8 (fatigue). EX, exercise group; CG, control group.
aTo assess higher levels of physical functioning, four additional items from the EORTC item bank were used. A domain-specific T-score was calculated for physical functioning using EORTC software. This T-score reflects the position of the participant relative to an age-matched and gender-matched European reference population, with 50 representing average physical functioning.
bThese models included participants for whom valid Fitbit data (that is, wearing the Fitbit for >4 days around measurement timepoints for ≥10 h per day) could be retrieved (CG, 106; EX, 111).