Table 3.
Safety and effectiveness assessment: lymphedema, muscular strength, and body image outcomes
| Strength After Breast Cancer effectiveness trial | Physical Activity After Lymphedema efficacy trial (5,6) | |||||||
|---|---|---|---|---|---|---|---|---|
| No. of Obs. | Baseline | 12 months | P | No. of Obs. | Baseline | 12 months | P | |
| Lymphedema effectiveness outcomes | ||||||||
| Number of symptoms* | 66 | 2.6±2.6 | 1.7±2.1 | .002 | 131 | 3.3±3.2 | 2.2±2.6 | <.001 |
| Severity of symptoms* | 66 | 1.6±0.5 | 1.4±0.5 | .058 | 131 | 2.0±0.7 | 1.6±0.7 | <.001 |
| Arm volume (% interlimb difference) | 48 | 0.68±5.87 | 0.66±5.07 | .98 | 131 | 7.22±12.40 | 6.84±11.66 | .40 |
| Lymphedema safety outcomes | ||||||||
| New lymphedema onset† | 49 | — | 4 (8%) | — | 72 | — | 8 (11%) | — |
| Flare-up of existing lymphedema‡ | 27 | — | 5 (19%) | — | 71 | — | 9 (14%) | — |
| Muscular strength outcomes | ||||||||
| Bench press, lbs. | 34 | 45±11 | 51±13 | <.001 | 115 | 42±14 | 53±15 | <.001 |
| Leg press, lbs. | 37 | 190±58 | 208±54 | .012 | 120 | 174±55 | 222±59 | <.001 |
| Body image and relationships | ||||||||
| Strength and health | 66 | 34.2±9.2 | 28.7±9.3 | <.001 | 120 | 33.8±9.3 | 28.0±8.8 | <.001 |
| Social barriers | 64 | 19.8±7.0 | 17.0±6.3 | .003 | 111 | 16.6±6.5 | 14.8±5.5 | <.001 |
| Appearance and sexuality | 65 | 30.8±6.7 | 27.7±7.2 | <.001 | 104 | 30.0±8.0 | 27.0±7.7 | <.001 |
| Total score | 63 | 85.8±19.9 | 74.0±20.3 | <.001 | 116 | 81.2±20.2 | 70.0±19.1 | <.001 |
* Data were reported by patients for 14 symptoms: rings too tight, watch too tight, bracelets too tight, clothing too tight, puffiness, knuckles not visible, veins not visible, skin feels leathers, arm feel tired, pain, pitting, swelling after exercise, difficulty writing, or other. The change in severity of symptoms is the mean of the changes in severity for all 14 symptoms, with the possible severity score for each ranging from 0 (no symptom) to 4 (very severe).
† New lymphedema onset defined by a ≥5% increase in interlimb arm difference from baseline among women who entered the study with an interlimb arm volume difference <5% (interlimb volume difference: ((affected arm volume − unaffected arm volume)/unaffected arm volume).
‡ Flare-up of existing lymphedema defined by expert clinical evaluation among women who entered the study with an interlimb arm volume difference ≥5%.