Penttinen 2011.

Study characteristics
Methods	Study design: RCT Number randomized: 573; 302 to the exercise group and 271 to the control group Study start and stop dates: enrolment between September 2005 and September 2007 Length of intervention: 12 months Length of follow‐up: 6 and 12 months after baseline
Participants	Type cancer: breast cancer Time since cancer diagnosis: not reported Time beyond active treatment, median (range) weeks: time since surgery: 33 (27 to 40) weeks time since last chemotherapy: 12 (5 to 17) weeks time since last radiation therapy: 4 (‐2 to 10) weeks  Inclusion criteria: histologically confirmed newly diagnosed invasive breast cancer (T1‐4 NO‐3 MO) pre‐ and postmenopausal treated with adjuvant chemotherapy or radiation therapy within 4 month started endocrine therapy (antiestrogens, aromatase inhibitors, luteinizing hormone‐releasing hormone agonists, or a combination) no more than 4 months earlier 35 to 68 years old signed informed consent prior to beginning protocol specific procedures Eligibility criterion related to interest or ability to exercise, or both: incapable of training, (e.g. severe cardiac disease, osteoporosis, severe knee arthrosis, ligament or cartilage injuries at lower extremities) other serious illness or medical condition, which could be contraindication for exercise Exclusion criteria: male gender prior malignancy except basal cell carcinoma or in situ carcinoma hematogenous metastases (M1) systemic adjuvant therapy postmenopausal women with antiestrogens as the only adjuvant treatment (with or without radiation therapy) pregnancy or recent lactation (< 1 year) severe cardiac disease (NYHA class III or greater), myocardial infarction within 12 months, uncontrolled hypertension verified osteoporosis (proximal femur or lumbar spine T‐score < ‐2.5 or fracture without trauma) concomitant medications affecting calcium and bone metabolism such as bisphosphonates, calcitonin, parathyroid hormone, selective estrogen receptor modulators, oral corticosteroids (over 6 months), anticonvulsants (phenytoin, carbamatsebin), and prolonged heparin therapy other diseases affecting calcium and bone metabolism such as hyperthyroidism, newly diagnosed hypothyroidism, primary hyperparathyroidism, renal failure, chronic hepatic diseases, organ transplant residency more than 1 hour from the exercise center competitive athlete only treated with radiation therapy Gender: female Current age, mean (range) years: 52.4 (35 to 68) years Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level, mean (SD) years: 13.9 (3.4) years SES: not reported Employment status, n (%): self‐employed, 20 (3.7%); upper‐level employees, 101 (18.8%); lower‐level employees, 227 (42.3%); manual workers, 45 (8.4%); students, 5 (0.9%); pensioner, housewives, 98 (18.2%); unemployed, 16 (3.0%); missing, 25 (4.7%) Comorbidities, n (%): hypertension, 108 (20.1%); cardiovascular diseases, 10 (1.9%); diabetes, 12 (2.2%); psychiatric disease, 48 (8.9%) Past exercise history, n (%): inactive, 92 (17.1%); exercising with moderate intensity, 282 (52.5%); vigorous exercising, 114 (21.2%); missing, 49 (9.1%) On hormone therapy, n (%): 445 (82.9%) BMI, n (%): < 25 (normal weight), 231 (43.0%); 25 to 30 (overweight), 204 (38.0%); > 30 (obese), 102 (19.0%)
Interventions	302 participants assigned to a 2‐component supervised exercise training intervention, with each component performed in alternate weeks. The components included: 1 supervised session of vigorous step aerobics, comprised of 150 to 180 jumps and leaps in diverging directions, progressing from 10‐cm high benches to 15‐cm benches after 4 months and 20‐cm benches after 8 months. Music was set as 118 beats per minute circuit training started with 100 steps and hops per session, progressing 150 to 180 steps and hops per session, with more demanding jumps in the later phase. The session started with a 20‐second training period followed by 60‐second rest and progressed to a 40:60 second training/rest ratio and then a 30:60 second ratio with more demanding jumps such as heel drops, star jumps, and skate jumps In addition, there were 2 to 3 similar home training sessions Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: vigorous Frequency: once per week and 2 to 3 similar home sessions Duration of individual sessions: 60 minutes Duration of exercise program: 12 months Total number of exercise sessions: 52 supervised sessions and 104 to 156 home training sessions Format: group (at facility) and individual (at home) Facility: facility and home Professionally led by experienced physical therapists who all had also received a similar training for the study exercises 271 participants assigned to the control group, including: usual care Adherence: 24 premenopausal trainees attended a median of 30/52 (58%) supervised training sessions 6/124 (5%) did not attend any training 23/124 (18%) attended < once a month 78/124 (63%) attended at least every second week (i.e. > 25 times) Based on 109 returned training diaries, premenopausal participants completed home training on average 2.8 times weekly for a total time of 2.9 hours. The median total number of training sessions (supervised and home training sessions together) was 3.3 times per week (interquartile range 2.4 to 4.6) Postmenopausal trainees attended a median of 33/52 (63%) training sessions: 2/138 (< 2%) did not attend any session 27/138 (20%) attended sessions < once a month 96/138 (70%) attended at least every second week Based on 122 returned training diaries, postmenopausal participants completed home training 3.2 times (107%) weekly for a total time of 3.5 hours. The median total number of training sessions was 4.3 times per week (interquartile range 2.3 to 5.4)   Contamination of control group: not reported
Outcomes	No primary outcome was identified. QoL outcomes included: QoL, measured using the EORTC QLQ‐C30 fatigue, measured using the FACIT‐F scale depression, measured using the BDI Physical outcomes included: physical performance body composition bone density QoL outcomes were measured at baseline, but there is no report on whether these outcomes were measured at follow‐up. Physiologic outcomes were measured at baseline, and 6 and 12 months. These outcomes were measured as follows: exercise group: n = 302 at baseline, n = 262 for physiologic outcomes at 6 and 12 months control group: n = 271 at baseline, n = 236 for physiologic outcomes at 6 and 12 months Subgroup analysis: none reported Adverse events: none reported
Notes	Country: Finland Funding: Finnish Cancer Institute; Finnish Cancer Foundation; Academy of Finland; Social Insurance Institution of Finland; Finnish Ministry of Education; Finska Läkaresällskapet; Special government grant for health science research; Helander Foundation; Gyllenberg Foundation; Paulo Foundation; Kurt and Doris Palander Foundation; Finnish Cultural Foundation and Medical Fund of the Pirkanmaa Hospital District; Finnish Astra‐Zeneca sponsored step benches for the study; Finnish Breast Cancer group
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The generation of the random sequence was not described
Allocation concealment (selection bias)	Unclear risk	Whether the treatment assignment was concealed from study personnel and participants was not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Owing to the nature of the intervention, it was not possible to blind the participants; however, it is unclear whether the outcome was influenced by a lack of masking
Blinding of outcome assessment (detection bias) All outcomes	High risk	Study personnel and outcome assessors were not masked or blinded to the study interventions
Incomplete outcome data (attrition bias) All outcomes	High risk	There was no ITT analysis and it is unclear how missing data were handled. Analyses were completed on 262/302 women in the intervention group and in 236/271 women in the control group
Selective reporting (reporting bias)	Low risk	There appears to be no selective reporting of outcomes
Other bias	Low risk	The trial appears to be free of other problems that could put it at a high risk of bias