Heim 2007.
Study characteristics | ||
Methods | Study design: quasi‐RCT Number randomized: 63; 32 assigned to the exercise group and 31 to the control group Study start and stop dates: not reported Length of intervention: unclear Length of follow‐up: 3 months' postrehabilitation |
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Participants | Type cancer: breast cancer Time since cancer diagnosis: not reported Time beyond active treatment: not reported, but at least 6 weeks since surgery or chemotherapy Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both: not reported Exclusion criteria:
Gender: female Current age, n (%):
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level: not reported SES: not reported Employment status, n (%):
Comorbidities: not reported Past exercise history (before disease), n (%):
On hormone therapy: none |
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Interventions | 32 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: not reported Frequency: instructions were to complete strength training 3 times per week and aerobic exercise for 30 minutes twice per week Duration of exercise session: not reported Duration of exercise program: not reported Total number of exercise sessions: not reported Format: individual Facility: inpatient rehabilitation center, but exercises could also be completed at home Professionally led: initial instruction and printed brochures, but no further instruction Adherence: assessed as percentage (where adherence to program was equal to 100%), adherence to:
31 participants assigned to control group, including:
Contamination of control group: not reported, although this group received group exercises |
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Outcomes | Outcomes: QoL outcomes, including:
Outcomes were measured at baseline, after rehabilitation and at 3 months, 59 participants with complete data:
Adverse events: not reported |
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Notes | Country: Germany Funding: German Fatigue Society |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "according to their admission to hospital; depending on the alternating weeks they were allocated to the intervention group or the control group." |
Allocation concealment (selection bias) | High risk | Because of alternation, the investigators were aware of the next treatment assignment |
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 were complete data packets for 59 participants, but no information on missing patients. Also, "More patients in the control group (15) than in the training group (12) did not continue the study" |
Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
Other bias | Unclear risk | Poorly described study |