Cormie 2014.

Methods	Study design: RCT Number randomised: 62; 22 to high‐load resistance exercise, 21 to low‐load resistance exercise, 19 to control Study start: June 2010; stop date: not stated Length of intervention: 3 months Length of follow‐up: to end of intervention Country: Australia
Participants	Age, years (mean SD): High‐load resistance exercise (HLRE): 56.1 (8.1) Low‐load resistance exercise (LLRE): 57.0 (10.0) Control: 58.6 (6.7) Stage, n (%): HLRE: stage I, 2 (9.1); stage II, 18 (81.8); stage III, 2 (9.1) LLRE: stage I, 5 (23.8); stage II, 10 (47.6); stage III, 6 (28.6) Control: stage I, 6 (31.6); stage II, 9 (47.3); stage III, 4 (21.1) Time since cancer diagnosis, mean (SD) years: HLRE: 5.9 (6.1) LLRE: 6.1 (5.2) Control: 9.5 (9.8) Inclusion criteria: • Histological diagnosis of breast cancer at least 1 year before the study • Clinical diagnosis of breast cancer‐related lymphoedema and medical clearance from general practitioner • Clinical diagnosis of lymphoedema defined as having at least a 5% inter‐limb discrepancy in volume or circumference at the point of greatest visible difference Exclusion criteria: • Unstable lymphoedema defined as receiving intensive therapy (i.e. decongestive therapy or antibiotics for infection) within the previous 3 months • Musculoskeletal, cardiovascular, and/or neurological disorder that could inhibit exercise
Interventions	43 participants assigned to 1 of 2 resistance exercise interventions Two 60‐minute exercise sessions were performed per week for 3 months. Intensity varied across conditions (moderate‐high (12 to 16 RPE); high‐load, 75% to 85% of 1RM using 10‐6 RM, 1 to 4 sets per exercise; low‐load, 55% to 65% of 1RM using 20‐15 RM, 1 to 4 sets per exercise) Exercise sessions were conducted in groups of up to 8 to 10 participants. The resistance exercise regimen included 6 exercises that targeted major upper body muscle groups including chest, back, shoulders, upper arms, and forearms (chest press, seated row/lat pulldown, shoulder press/lateral raise, biceps curl, triceps extension, and wrist curl). Additionally, 2 exercises targeting major muscle groups of the lower body were performed (leg press/leg extension, squat/lunge). Adherence: Exercise attendance was high for both resistance training groups, with an average of 23.2 ± 1.9 out of a possible 24 sessions attended (HLRE 23.4 ± 1.1; LLRE 22.9 ± 2.4). 19 participants assigned to control: Participants randomised to the control group were offered the exercise programme after completion of the intervention period. All participants were instructed to maintain their usual lymphoedema self‐care management regimen, physical activity levels, and diet throughout the intervention period.
Outcomes	Primary outcome: Severity of swelling associated with breast cancer‐related lymphoedema assessed via standard objective measures: Bioimpedance spectroscopy (BIS) impedance ratio DEXA Arm circumference measurements Secondary outcomes: Severity of symptoms assessed via: Disability of the Arm, Shoulder, and Hand questionnaire (DASH) Brief pain inventory questionnaire (BPI) Arm morbidity subscale of the Functional Assessment of Chronic Illness Therapy breast cancer questionnaire for patients with lymphoedema (FACT‐B+4) Arm symptoms subscale of the European Organization for Research and Treatment of Cancer breast cancer module (QLQ‐BR23) Maximal grip strength tested with an isometric hand dynamometer (Model 78011; Lafayette Instruments, Lafayette, IN, USA). Affected and non‐affected limbs were assessed individually, and the best of 3 trials was reported. Maximal strength of major muscle groups assessed by the 1RM method in chest press, seated row, and leg press exercises Muscle endurance assessed by a repetition maximum test, which involved participants performing the maximal number of repetitions possible with 70% of current 1RM in the chest press, seated row, and leg press Range of motion about the wrist, elbow, and shoulder assessed by standard goniometric techniques Health‐related QoL assessed with MOS SF‐36 Numbers of participants assessed: HLRE: baseline, 22; at 3 months, 22 LLRE: baseline, 21; at 3 months, 21 Control: baseline, 19; at 3 months, 19 Adverse events: No lymphoedema exacerbations or any other adverse events were reported.
Notes	Trial registration link: ACTRN12610000788077 (http://www.anzctr.org.au/ACTRN12610000788077.aspx) Trial authors contacted: no Intention‐to‐treat analysis: yes, but using LOCF Funding: Edith Cowan University and University of Canberra
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomised in an allocation ratio of 1:1:1 by a random assignment computer programme.
Allocation concealment (selection bias)	Low risk	Exercise physiologists involved in assigning participants to groups were blinded to the allocation sequence.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Owing to the nature of the intervention, it was not possible to conceal allocation to the intervention from participants.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of outcome assessments was not described.
Incomplete outcome data (attrition bias) All outcomes	High risk	Missing data were addressed by imputing change across time as zero.
Selective reporting (reporting bias)	Low risk	No selective reporting of outcomes is apparent.
Other bias	Low risk	Trial appears to be free of other problems that could put it at high risk of bias.