Cantarero‐Villanueva 2013.

Methods	Study design: single‐centre RCT Numbers allocated, 68; 34 to exercise intervention; 34 to usual care Study start: March 2009; stop date: June 2010 Length of intervention: 8 weeks Length of follow‐up: at 6 months after discharge Country: Spain
Participants	Age, years (mean SD): Intervention: 48.4 (10.8) Control: 46.2 (7.4) Stage, n (%): Intervention: stage I, 4 (12.4); stage II, 23 (72.0); stage IIIA, 5 (15.5) Control: stage I, 10 (34.4); stage II, 14 (48.3); stage IIIA, 5 (17.3) Inclusion criteria: • Between 25 and 65 years old with a diagnosis of breast cancer (stage I‐IIIA) • Finished oncology treatment except hormone therapy in the previous 18 months • Exhibit clinically significant fatigue (> 3 in total score on the Piper Fatigue Scale) Exclusion criteria: • Receiving oncology treatment at the time of the study • Physical limitations associated with orthopaedic conditions
Interventions	34 participants assigned to exercise intervention: 8‐Week water‐based intervention was carried out 3 times per week for a duration of 60 minutes (10 minutes of warm‐up, 40 minutes of aerobic and endurance exercises, and 10 minutes of cool‐down exercises) in an indoor heated swimming pool sized 25 × 12.5 m, with 140 to 200 cm water depth, 28°C of water temperature, and 30°C of room temperature. Aerobic exercises consisted of different horizontal movements: forward and backward jogging with arms moving, pulling, and pressing; leaps, leg cross‐overs, and hopping movements focussing on movement in multiple directions. Endurance exercises were considered moderate as the parameters set for each exercise included 2 to 3 sets of 8 to 12 repetitions. Adherence: 34 participants finished the aquatic exercise programme and completed 84% of the 24 physical therapy sessions (mean ± SD, 20 ± 4 sessions). 34 participants assigned to control: Participants allocated to the usual care group followed oncologist recommendations for maintaining a healthy lifestyle based on adequate nutrition, energy balance, and maintaining usual activities.
Outcomes	Primary outcomes: Piper Fatigue Scale (PFS) score Secondary outcomes: Mood state assessed via the Spanish version of the Profile of Mood States (POMS) containing 63 adjectives rated by participants on a 5‐point scale Lower body muscular strength assessed via the “multiple sit‐to‐stand test” involves counting the time in seconds needed by participants to rise until they reach full knee extension and sit back, 10 times, as fast as possible Muscular endurance of abdominal muscles tested via the trunk curl static endurance test Numbers of participants assessed: Intervention: baseline, 34; at 8 weeks, 34; at 6 months, 32 Control: baseline, 34; at 8 weeks, not stated; at 6 months, 29 Adverse events: Adverse effects reported during the study included discomfort or low‐intensity pain/stiffness after an exercise session in 3 participants; nevertheless, they continued the programme.
Notes	Trial registration link: none available Trial authors contacted: no Intention‐to‐treat analysis: no Funding: Health Institute Carlos III and PN I+D+I 2008‐2011, Madrid, Spanish government (grant no. FIS PI10/02749); Research Office of the University of Granada, Spain
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated numbers produced a sequence that was entered into opaque envelopes.
Allocation concealment (selection bias)	Low risk	“Computer‐generated number sequence was entered into opaque envelopes. These envelopes were opened by a blinded researcher after the first outcome measurement”.
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	Assessors were blinded to treatment allocation.
Incomplete outcome data (attrition bias) All outcomes	High risk	Only those who completed postintervention and 6‐month assessments were included in analysis.
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.