Table 1.
Participants’ treatment* and baseline characteristics. Values are numbers (percentages) unless stated otherwise
| Characteristics | Usual care | Exercise | Total |
|---|---|---|---|
| Randomised to treatment | (n=191) | (n=191) | (n=382) |
| Mean (SD) age, years | 57.8 (12.0) | 58.4 (12.2) | 58.1 (12.1) |
| Mean (SD) body mass index; (missing) | 30.6 (7.2); (5) | 29.9 (6.9); (6) | 30.2 (7.0); (11) |
| Body mass index: | |||
| <25 | 44 (23) | 50 (26) | 94 (25) |
| 25-<30 | 51 (27) | 53 (28) | 104 (27) |
| ≥30 | 91 (48) | 82 (43) | 173 (45) |
| Missing | 5 (3) | 6 (3) | 11 (3) |
| Axillary surgery: | |||
| Axillary node clearance | 162 (85) | 165 (86) | 327 (86) |
| Sentinel lymph node biopsy | 26 (14) | 26 (14) | 52 (14) |
| None | 2 (1) | 0 | 2 (<1) |
| Missing | 1 (<1) | 0 | 1 (<1) |
| Radiotherapy: | |||
| Yes | 166 (87) | 151 (79) | 317 (83) |
| No | 14 (7) | 26 (14) | 40 (10) |
| Missing | 11 (6) | 14 (7) | 25 (7) |
| Site of radiotherapy†: | |||
| Breast | 114 (60) | 94 (49) | 208 (54) |
| Chest wall | 50 (26) | 57 (30) | 107 (28) |
| Axilla/supraclavicular area | 62 (32) | 51 (27) | 113 (30) |
| Radiotherapy boost given | 60 (31) | 44 (23) | 104 (27) |
| Chemotherapy given | 118 (62) | 108 (57) | 226 (59) |
| Axillary node clearance and axillary/supraclavicular radiotherapy | 65 (34) | 53 (28) | 118 (31) |
| Baseline characteristics‡ | (n=175) | (n=175) | (n=350) |
| Marital status: | |||
| Single | 18 (10) | 15 (9) | 33 (9) |
| Married/cohabiting | 127 (73) | 124 (71) | 251 (72) |
| Divorced/separated/widowed | 30 (17) | 34 (19) | 64 (18) |
| Missing | 0 | 2 (1) | 2 (<1) |
| Education: | |||
| School only | 54 (31) | 58 (33) | 112 (32) |
| Work qualification | 36 (21) | 35 (20) | 71 (20) |
| College or university | 84 (48) | 80 (46) | 164 (47) |
| Missing | 1 (<1) | 2 (1) | 3 (1) |
| Employment status: | |||
| Full or part time employed | 65 (37) | 70 (40) | 135 (39) |
| Self-employed | 6 (3) | 10 (6) | 16 (5) |
| Retired | 67 (38) | 65 (37) | 132 (38) |
| Housewife, mother/carer | 16 (9) | 6 (3) | 22 (6) |
| Illness/disability/other | 16 (9) | 23 (13) | 39 (11) |
| Missing | 5 (3) | 1 (<1) | 6 (2) |
| Ethnicity: | |||
| White | 159 (91) | 162 (93) | 321 (92) |
| Asian | 12 (7) | 5 (3) | 17 (5) |
| Afro-Caribbean | 1 (<1) | 2 (1) | 3 (1) |
| Mixed | 0 (0) | 2 (1) | 2 (<1) |
| Other | 2 (1) | 3 (2) | 5 (1) |
| Missing | 1 (<1) | 1 (<1) | 2 (<1) |
| Comorbidities: | |||
| None | 47 (27) | 47 (27) | 94 (27) |
| 1-2 | 86 (49) | 90 (51) | 176 (50) |
| ≥3 | 42 (24) | 38 (22) | 80 (23) |
| Any shoulder problem: | |||
| Yes | 29 (17) | 45 (26) | 74 (21) |
| No | 120 (69) | 105 (60) | 225 (64) |
| Missing | 26 (15) | 25 (14) | 51 (15) |
| Upper limb function: | |||
| Mean (SD) DASH; (missing) | 18.2 (19.8); (4) | 19.5 (21.2); (8) | 18.8 (20.5); (12) |
| Median (IQR) DASH | 11.7 (1.7-30.0) | 12.5 (2.5-30.8) | 12.3 (1.7-30.2) |
| Neuropathic pain, DN4: | |||
| No pain | 95 (54) | 89 (51) | 184 (53) |
| ≤3 (non-neuropathic pain) | 57 (33) | 63 (36) | 120 (34) |
| >3 (neuropathic pain) | 17 (10) | 16 (9) | 33 (9) |
| Missing | 6 (3) | 7 (4) | 13 (4) |
| Mean (SD) pain intensity, NRS; (missing) | 1.9 (2.5); (6) | 1.9 (2.4); (13) | 1.9 (2.4); (13) |
| Mean (SD) FACT-B+4; (missing) | 2.7 (4.0); (0) | 3.1 (4.2); (1) | 2.9 (4.1); (1) |
| Lymphoedema, LBCQ: | |||
| Arm feels heavy | 38 (22) | 43 (25) | 81 (23) |
| Arm looks swollen | 27 (15) | 25 (14) | 52 (15) |
| Arm heavy and swollen | 20 (11) | 17 (10) | 37 (11) |
| Arm neither heavy not swollen | 152 (87) | 148 (85) | 300 (86) |
| Missing | 3 (2) | 10 (6) | 13 (4) |
| Health related quality of life: | |||
| Mean (SD) EQ-5D-5L; (missing) | 0.67 (0.22); (18) | 0.68 (0.20); (16) | 0.67 (0.2); (34) |
| Mean (SD) SF-12 PCS; (missing) | 47.6 (11.6); (8) | 46.8 (11.6); (7) | 47.2 (11.6); (15) |
| Mean (SD) SF-12 MCS; (missing) | 44.7 (11.7); (8) | 46.8 (10.6); (7) | 45.8 (11.2); (15) |
| Outside walking, days per week: | |||
| Never or seldom (1-2) | 38 (22) | 46 (26) | 84 (24) |
| Sometimes (3-4) | 51 (29) | 54 (31) | 105 (30) |
| Often (5-7) | 85 (49) | 75 (43) | 160 (46) |
| Missing | 1 (<1) | 0 | 1 (<1) |
| Strenuous sport/recreation, days per week: | |||
| Never | 134 (77) | 132 (75) | 266 (76) |
| Seldom (1-2) | 26 (15) | 25 (14) | 51 (15) |
| Sometimes/often (≥3) | 13 (7) | 15 (9) | 28 (8) |
| Missing | 2 (1) | 3 (2) | 5 (1) |
| Mean (SD) confidence scores; (missing): | |||
| Return to usual activities | 7.5 (2.5); (2) | 8.1 (2.3); (0) | 7.8 (2.4); (2) |
| Return to physical activity | 7.5 (2.3); (2) | 8.0 (2.3); (0) | 7.7 (2.3); (2) |
DASH=Disability of Arm, Shoulder and Hand; DN4=Dolour Neuropathique-4; FACT-B+4=Functional Assessment of Cancer Therapy-Breast+4 arm scale; IQR=interquartile range; LBCQ=Lymphoedema and Breast Cancer Questionnaire; MCS=mental component summary score; NRS=numerical rating scale; PCS=physical component summary score.
*
Treatment variables are most invasive surgery/adjuvant therapy by 12 month follow-up.
†
Radiotherapy administered to >1 site; hence multiple response options possible.
‡
350/382 (92%) completed baseline questionnaires pre-randomisation.