Physical activity for the affected limb and arm lymphedema after breast cancer surgery. A prospective, randomized controlled trial with two years follow-up

Figures & data

Figure 1.  Patient flow chart.

Table I.  Baseline values in the no activity restrictions (NAR) and activity restrictions (AR) groups.

	NAR n = 104 (%)	AR n = 100 (%)	P*
Characteristics
Age, years	54±90.6	55±90.5	0.27†
Body mass  index	24±30.3	25±40.0	0.19†
Affected arm volume, ml	2348±365	2424±407	0.16†
Control arm volume, ml	2363±383	2404±423	0.47†
Voldiff, ml	−12±121	20±132	0.065†
Surgery
Nodes removed	13±40.0	13±40.1	0.79†
Metastasized nodes	10.97±30.6	10.84±30.0	0.78†
Breast ablation	46 (44)	51 (51)	0.37
Breast conserving	57 (55)	49 (49)	0.37
Surgery, dominant side	51 (48)	58 (58)	0.20
Cancer treatment
Radiotherapy, supraclavicular nodes	47 (45)	40 (40)	0.48
Radiotherapy, breast	78 (75)	73 (73)	0.78
Chemotherapy	42 (40)	38 (38)	0.73
Antihormone treatment	48 (46)	50 (50)	0.58
Histology grade 1	25 (24)	19 (19)	0.40
Histology grade 2	54 (52)	56 (56)	0.58
Histology grade 3	24 (23)	24 (24)	10.00

*χ² test, † t test and Mann-Whitney test. Data are expressed as number of patients or mean, standard deviations, and percentages (%).

Figure 2.  Questionnaire for the recording of physical activity involving the affected upper limb.

Figure 3.  Affected arm volume in ml from baseline to 2 years for the no activity restrictions (NAR) and activity restrictions (AR) groups.

Table II.  Intention to treat analysis between the (NAR) no activity restrictions (n = 104) and the (AR) activity restrictions (n = 100) groups.

Voldiff in ml, mean (SD)
NAR
3 months	20 (120)
6 months	32 (129)
2 years	52 (153)
AR
3 months	49 (125)
6 months	64 (158)
2 years	82 (165)
NAR-AR, mean difference in ml
3 months	−8
6 months	−15
2 years	−16

Voldiff, difference between affected and control arm volume; SD, standard deviation; VAS, visual analogue scale; CI, confidence interval.

ANCOVA * P<0.05.

Table III.  Pain in the affected arm during physical activity for the no activity restrictions (NAR) and activity restrictions (AR) groups.

VAS	No pain 0 mm (%)	Pain 1-20 mm (%)	Pain > 21 mm (%)
3 months
NAR	19 (22)	35 (40)	33 (38)
AR	47 (55)	16 (19)	22 (26)
6 months
NAR	41(40)	36 (35)	27 (25)
AR	64 (64)	23 (23)	13 (13)
2 years
NAR	62 (61)	26 (24)	16 (15)
AR	64 (64)	20 (17)	16 (17)

*P<0.05; numbers, percentages, and degrees of pain in mm; VAS (visual analogue scale) = 0-100 mm.

Table IV.  Risk factors for the development of arm lymphedema (ALE) 2 years after surgery.

	OR	95% CI	P
BMI at baseline (>25 kg/m^2)	3.42	1.45–8.06	0.005
Voldiff preoperatively (>0 ml)	1.43	0.589–3.49	0.427
Sensation of heaviness at 3 months (VAS > 0 mm)	1.54	0.455–5.24	0.486
Pain at 3 months (VAS > 0 mm)	0.78	0.227–2.69	0.781

Visual Analogue Scale (VAS), Body Mass Index (BMI) Odds Ratio (OR), confidence interval (CI). Dependent variable: Voldiff > 200 ml increase at 2 years.