Speck 2010.

Study characteristics
Methods	Study design: RCT Number randomized: 295; 148 (71 with lymphedema and 77 without lymphedema) to the exercise group and 147 (70 with lymphedema and 77 without lymphedema) to the control group Study start and stop dates: recruitment took place between October 2005 and February 2007 Length of intervention: 12 months Length of follow‐up: to end of the intervention
Participants	Type cancer: breast cancer Cancer Stage, for women with lymphedema, n (%): exercise group: DCIS, 0 ()%); Stage I, 13 (24%); Stage II, 20 (37%); Stage III, 4 (7%); unknown, 17 (32%) control group: DCIS 6 (10%); Stage I, 8 (14%); Stage II, 14 (24%); Stage III, 11 (19%); unknown, 19 (33%) Cancer Stage, for women without lymphedema, n (%): exercise group: DCIS 1 (2%); Stage I, 22 (37%); Stage II, 19 (32%); Stage III, 6 (10%); unknown, 11 (19%) control group: DCIS 1 (2%); Stage I, 22 (35%); Stage II, 17 (27%); Stage III, 2 (3%); unknown, 21 (33%) Time since cancer diagnosis, for women with lymphedema, mean (SD) months: exercise group: 78 (42) months control group: 89 (45) months Time since cancer diagnosis, for women without lymphedema, mean (SD) months: exercise group: 37 (14) months control group: 42 (15) months Time beyond active treatment: not reported  Inclusion criteria: female history of unilateral nonmetastatic breast cancer BMI < 50 kg/m2 currently cancer free  Additional inclusion criteria, for women with lymphedema: 1 to 15 years post‐diagnosis at least 1 lymph node removed presence of lymphedema Additional inclusion criteria, for women without lymphedema: 1 to 5 years post‐diagnosis at least 2 lymph nodes removed Eligibility criteria related to interest or ability to exercise, or both: medical condition limiting participation in an exercise program weight lifting in the year prior to study entry weight stable and not actively trying to lose weight (by self‐report) Exclusion criteria: affected limb changes of > 5% between repeated baseline measurements medical conditions or medications that would negatively affect the ability to assess BMI history of bilateral lymph node dissection plans for surgery or pregnancy plans to move from the area or be away for ≥ 1 month during the study period Additional exclusion criteria, for women with lymphedema: intensive therapy within the past 3 months recorded 10% change in volume or circumference of the affected arm in the last 3 months for ≥ 7 days more than 1 lymphedema‐related infection requiring antibiotics (cellulitis) within the past 3 months change in Activities of Daily Living Gender: female Current age, for women with lymphedema, mean (SD) years: exercise group: 56 (9) years control group: 58 (9) years Current age, for women without lymphedema, mean (SD) years: exercise group: 55(7) years control group: 57 (8) years Age at cancer diagnosis: not reported Ethnicity/race, for women with lymphedema, n (%): exercise group: white, 31 (57%); black, 23 (43%); other, 0 (0%) control group: white, 34 (59%); black, 22 (38%); other, 2 (3%) Ethnicity/race, for women without lymphedema, n (%): exercise group: white, 42 (71%); black, 13 (22%); other, 4 (7%) control group: white, 52 (83%); black, 11 (17%); other, 0 (0%) Education level, for women with lymphedema, n (%): exercise group: high school or less, 8 (15%); some college, 17 (31%); college or more, 29 (54%) control group: high school or less, 12 (21%); some college, 20 (34%); college or more, 26 (45%) Education level, for women without lymphedema, n (%): exercise group: high school or less, 4 (7%); some college, 20 (34%); college or more, 35 (59%) control group: high school or less, 9 (14%); some college, 18 (29%); college or more, 36 (57%) SES: not reported Employment status, for women with lymphedema, n (%): exercise group: professional, 15 (28%); clerical/service, 7 (13%); unemployed, 2 (4%); other/unknown, 19 (35%); retired, 11 (20%) control group: professional, 17 (29%); clerical/service, 8 (14%); unemployed, 1 (2%); other/unknown, 10 (17%); retired, 22 (38%) Employment status, for women without lymphedema, n (%): exercise group: professional, 21 (36%); clerical/service, 12 (20%); unemployed, 2 (3%); other/unknown, 15 (25%); retired, 9 (15%) control group: professional, 25 (40%); clerical/service, 9 (14%); unemployed, 2 (3%); other/unknown, 14 (22%); retired, 13 (21%) Comorbidities: n reported Past exercise history: not reported On hormone therapy: not reported
Interventions	148 participants (71 with lymphedema and 77 without lymphedema) assigned to the exercise intervention, consisting of progressive strength (weight) training including: 10 minutes of cardiovascular exercise warm‐up brief range of motion stretching of the major muscle groups to be worked during strength training 5 to 15 minutes of exercises intended to strengthen spinal stabilization muscles and deep abdominal muscles and increase awareness of body‐mind connection stretching at the end of each session for injury prevention purposes, during which each stretch was held for at least 30 seconds weights were increased throughout the intervention period Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of experimental exercise intervention: not reported Frequency: twice per week Duration of individual sessions: 90 minutes Duration of exercise program: 52 weeks Total number of exercise sessions: 104 sessions Format: group Facility: community fitness center, usually a Young Mens Christian Association facility Professionally led and supervised for the first 3 months by fitness professionals employed by the fitness center and certificated by a National Committee for Certifying Agencies accredited organization, such as the ACSM 147 participants (70 with lymphedema and 77 without lymphedema) assigned to the control group, including: waiting list control requested not to change current level of exercise Adherence: for women with lymphedema: median attendance to weight lifting sessions was 88%; for women without lymphedema: median attendance to weight lifting sessions was 79% Contamination of control group: not reported
Outcomes	Primary outcome: limb volume assessed by water displacement Secondary QoL measures included: body image, measured using the Body Image and Relationship Scale QoL measures assessed using the Health and Attitudes Survey, including: MOS SF‐36 PSQI relationship and body image fatigue Coopersmith self‐esteem life orientation visual analog QoL scale medical outcome and support temporal SWLS depression survey Secondary physical measures included: lymphedema, assessed by circumference measure and onset/flare‐up moderators upper body function testing, assessed using the 9 Hole Peg Test of Finger Dexterity body composition, measured using BMI, body fat, bone density muscle strength testing bioelectrical spectroscopy pain, assessed using a visual analog scale All outcomes were measured at baseline and 1 year. Some outcomes were also measured at 3 and 6 months. For women with lymphedema, outcomes were measured as follows: exercise group: n = 71 at baseline, n = 54 at 1 year control group: n = 70 at baseline, n = 58 at 1 year For women without lymphedema, outcomes were measured as follows: exercise group: n = 77 at baseline, n = 59 at 1 year control group: n = 77 at baseline, n = 63 at 1 year Subgroup analysis: a large number of subgroup analyses were prespecified Adverse events: none reported
Notes	Country: US Funding: NIH/National Cancer Institute and the Public Health Services Research Grant
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Allocation sequence was a computer generated minimization scheme
Allocation concealment (selection bias)	Low risk	"...de‐identified data for ... variables were entered after completion of all baseline measures, the study coordinator then called participants to reveal the outcome of randomization and to schedule groups for the supervised groups"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Owing to the nature of the intervention, it was not possible to mask the participants; however, it is unclear whether the outcome was influenced by a lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Study personnel were not masked or blinded about the allocation, but the outcome assessors measuring physical outcomes were blinded to allocation
Incomplete outcome data (attrition bias) All outcomes	High risk	There is no evidence that missing data were adequately and appropriate addressed. Large numbers of study participants withdrew; among those with lymphedema, 17 women in the exercise group and 12 women in control group withdrew; where, among women without lymphedema, 18 women in the exercise group and 16 women in control group withdrew
Selective reporting (reporting bias)	High risk	The report presents on only some of the outcomes measured in the trial
Other bias	Low risk	No other biases were apparent