Mehnert 2011.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 63; 35 to the exercise group and 28 to the control group Study start and stop dates: not reported Length of intervention: 10 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: non‐metastatic breast cancer, stages I to III Stage of cancer, n (%):
Time since cancer diagnosis: not reported Time beyond active treatment: at least 4 weeks following chemotherapy, radiation therapy, or both 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, n (%):
SES: not reported Employment status, n (%):
Comorbidities: not reported Past exercise history:
On hormone therapy: not reported |
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Interventions | 35 participants assigned to a structured physical training program developed to promote muscular strength and exposure, including:
Although 35 women were assigned to the exercise intervention, 5 women refused to participate prior to the baseline assessment Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: maximum of 60% VO2 Frequency: twice per week Duration of individual sessions: 90 minutes Duration of exercise program: 10 weeks Total number of exercise sessions: 20 Format: group Facility: indoor sports facility and outdoors Professionally led by trained member of study staff (qualified physical therapist or sport therapist) 28 participants assigned to control group, including:
Adherence: not reported Contamination of control group: not reported |
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Outcomes | No primary outcome was identified. QoL outcomes included:
Outcomes were measured at baseline and 10 weeks: Different numbers of participants had data at the 2 time points as follows: Anxiety and depression:
Individual body Image:
Social body image:
Numbers of individuals with data for cancer‐specific HRQoL, generic HRQoL, and psychological symptoms were not reported Subgroup analysis: none reported Adverse events: no cancer recurrences or adverse events reported |
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Notes | Country: Germany Funding: Friedrich and Louise Homann Foundation, Hamburg, Germany |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | It is unclear how the allocation sequence was generated |
Allocation concealment (selection bias) | Low risk | The randomization was adequately concealed through external randomization |
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 | It is unclear how missing data were handled. 5 randomized participants were reported to have "cancelled" participation in the exercise group |
Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
Other bias | High risk | The small sample size and participation in physical exercise by women in the study groups can contribute to bias |