Herrero 2006.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 20, 10 to the exercise group and 10 to the control group Study start and stop dates: recruitment was from November 2003 to April 2004 Length of intervention: 8 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: Stage I or II ductal breast cancer, stage at diagnosis not reported Time since cancer diagnosis: not reported Time beyond active treatment, mean (SD) months:
Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
Gender: female Current age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level: not reported SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history: limited by exclusion criteria On hormone therapy: not reported Body mass and BMI, mean (SD):
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Interventions | 10 participants assigned to an exercise group, including:
Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of experimental exercise intervention: not reported Frequency: 3 times per week Duration of sessions: 90 minutes Duration of program: 8 weeks Total number of exercise sessions: 24 Format: not reported Facility: community fitness club (Miranda de Ebro, Spain) Professionally led: supervised by experienced investigator Adherence: mean (SD) % = 91.1% (6.9%); Control group: 10 participants assigned to:
Contamination of control group: not reported |
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Outcomes | Primary outcome: physical and QoL outcomes, including:
Secondary outcomes, included:
Outcomes were measured at baseline and 8 weeks (end of the intervention):
Adverse events: none reported |
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Notes | Country: Spain Funding: Universidad Europea de Madrid |
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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) | Low risk | "The treatment allocation system was set up so that the researcher who was in charge of enrolling participants did not know in advance which treatment the next person would get" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Owing to the nature of the intervention, masking or blinding of study participants was not possible; however, it is unclear whether the lack of masking could influence the outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Research assistants (exercise physiologists) with no knowledge of group assignments were designated to measure the outcome variables" |
Incomplete outcome data (attrition bias) All outcomes | High risk | 2 participants in each group withdrew. No information provided on withdrawals |
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 |