Portela 2008.

Methods	Study design: single‐centre RCT Number randomised: 44; 16 to gym‐exercise, 19 to home‐exercise, 9 to no‐exercise control Study start: recruitment began 2004; stop date: recruitment ended 2007 Length of intervention: 26 weeks Length of follow‐up: to end of intervention Country: Puerto Rico
Participants	Data available on the 34 participants who completed postintervention testing: Age, years (mean SD): Gym‐based exercise: 49.8 (6.9) Home‐based exercise: 51.2 (7.3) Control: 59.6 (16.7) Stage, n (%): Gym‐based exercise: stage I, 0 (0); stage II, 3 (25); stage III, 6 (50); stage IV, 0 (0); missing, 3 (25) Home‐based exercise: stage I, 3 (23); stage II, 5 (38); stage III, 2 (15); stage IV, 0 (0); missing, 3 (23) Control: stage I, 2 (22); stage II, 2 (22); stage III, 1 (11); stage IV, 1 (11); missing, 3 (33) Inclusion criteria: • Women with new diagnosis of unilateral breast cancer who had received surgical treatment for breast cancer in the past 5 years, with or without adjuvant therapy Exclusion criteria: • Unstable cardiac disease • Coagulopathies • Active psychiatric conditions • Metastasis • Haemoglobin level < 8.0 g/dL • Absolute neutrophil count < 0.5 × 1000/mL • Platelet count < 50 × 1000/mL • Ataxia, dizziness, or peripheral sensory neuropathy • Loss of more than 35% of premorbid weight • Dyspnoea • Bone pain • Severe nausea, extreme fatigue, and extreme muscle weakness. Exclusion criteria are considered contraindications to moderate‐intensity exercise programme following cancer diagnosis.
Interventions	35 participants assigned to 1 of 2 exercise interventions: Gym‐exercise group, in which staff met with participants once a week for exercise supervision and progression. The gym had qualified personnel who were present to assist participants during their exercise routine. Home‐exercise group, in which participants met with staff once a week, for the first 3 weeks. Thereafter, they met once a month to monitor and progress the exercise programme, in terms of walking and resistance intensity. A weekly telephone call was made by the program co‐ordinator. Both groups performed 2 resistance training sessions and 3 aerobic training sessions per week. The aerobic exercise mode was walking (30 minutes per session) for both groups. For the gym‐exercise group, resistance exercises targeted muscle groups of the chest, back, upper extremities, abdomen, and lower extremities. Weight training exercises were performed mainly with weight training machines, and when participants experienced difficulty with the machines, free weights were used. The resistance exercise component for the home group was provided via elastic bands (Theraband) and consisted of exercises targeting the chest, back, upper extremities, abdomen, and lower extremities muscle groups. Intensity of exercise: Gym‐exercise group, aerobic: walking at 60% to 80% HRmax (220‐age); resistance, 2 to 3 sets of 10 to 15 reps at 13 to 15 RPE (on 6 to 20 scale). Home‐exercise group, aerobic: walking at 12 to 16 RPE (6 to 20 scale); resistance, 2 to 3 sets of 10 to 15 reps at 13 to 15 RPE (on 6 to 20 scale). Adherence: Gym‐based exercise: Participation in aerobic sessions ranged from 19 to 54 (a mean of 37 sessions), for a percentage of participation ranging from 24% to 69%. Participation in strengthening sessions ranged from 12 to 46 (a mean of 33 sessions), for a percentage of participation ranging from 23% to 88%. Home‐based exercise: Endurance participation ranged from 27 to 69 sessions completed (a mean of 55 sessions); percentage of participation ranged from 35% to 88%. Participation in strengthening sessions ranged from 18 to 57 (a mean of 45 sessions); percentage of participation ranged from 35% to over 100%. 9 participants assigned to control: The control group continued receiving usual care provided by their physicians. At the end of their participation in the study, control group participants were offered an orientation session on the benefits of participating in an exercise programme, along with exercise brochures for home exercises and elastic bands.
Outcomes	Outcome: 12‐Minute walk test used to assess cardiorespiratory fitness Handgrip strength examined with a handheld dynamometer. Participants were evaluated in a seated position, with the arm resting at the side and the elbow flexed at 90° and the forearm in mid‐position between pronation and supination. BMI measured as an outcome Spanish version of FACT‐B also administered to assess quality of life Function measured via the DASH questionnaire Shoulder flexion, abduction, and external rotation examined through goniometry Volumetric measurements collected to monitor the development of lymphoedema with a volumetric oedema gauge; water displacement volumetry included to provide an estimate of volume of the upper extremity; volumetric measurements of the entire arm collected with the participant in a seated position Numbers of participants assessed: Gym‐based exercise: baseline, 16; at 13 weeks and post intervention, 12 Home‐based exercise: baseline, 19; at 13 weeks and post intervention, 13 Control: baseline, 9; at 13 weeks and post intervention, 9 Adverse events: None of the women had lymphoedema before enrolment in the study, and no participant developed it during the course of the study. One participant developed an asthma episode during the 12‐minute walk test at baseline evaluation. Another participant had an episode of hypoglycaemia while at the gym during an exercise session in the morning ‐ the result of skipping breakfast. Three participants presented high blood pressure (above 140/90 mmHg) during their participation in the exercise programmes. One participant from the gym‐exercise group complained of severe headache at the second evaluation session, after 3 months of participating in the programme without any symptoms. One participant from the gym‐exercise group complained of severe headache at the second evaluation session, after 3 months of participating in the programme without any symptoms. A participant in the gym‐exercise group complained of foot pain before beginning participation in the exercise programme. After the first exercise session, she commented on increased pain, underwent foot surgery recommended by her podiatrist, and decided not to continue in the study.
Notes	Trial registration link: none available Trial authors contacted: no Intention‐to‐treat analysis: no Funding: grant number 5P20RR011126 from the National Center for Research Resources, a component of the National Institutes of Health
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation of participants was performed by a computer‐generated scheme developed with the Statistical Analysis System.
Allocation concealment (selection bias)	Unclear risk	Whether allocation was concealed is unclear.
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	Low risk	“One physical therapist, blinded to group assignment, evaluated the participants in this study. Participants were instructed not to discuss their exercise programs or group assignment with the evaluator”.
Incomplete outcome data (attrition bias) All outcomes	High risk	Pre‐post‐test analysis was performed only on those who completed all assessments. No information regarding handling of missing data was provided.
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.