Fillion 2008.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 94; 48 to the exercise group and 46 to the control group Study start and stop dates: not reported Length of intervention: 4 weeks Length of follow‐up: 3 months |
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Participants | Type cancer: breast cancer, stages 0 to III Time since cancer diagnosis, mean (SD) days:
Time beyond active treatment: no more than 2 years 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, n (%):
Employment status, n (%):
Comorbidities: not reported Past exercise history: not reported On hormone therapy, tamoxifen, nolvadex, zoladex, arimidex, n (%):
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Interventions | 48 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: unclear Frequency: 4 times per week Duration of exercise session: 1 hour Duration of program: 4 weeks Total number of exercise sessions: 16 Format: group Facility: facility and home Professionally led: kinesiologist led the exercise, and an oncology nurse led the psycho‐educational component Adherence: 45 of 48 participants completed the full treatment Co‐intervention: psycho‐educative, fatigue management 46 participants assigned to the control group, including
Contamination of control group: not reported |
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Outcomes | Primary outcome: fatigue, measured with the General/Physical Fatigue subscale of the MFI Secondary outcomes: physical measures and QoL measures, including:
Outcomes were measured at baseline, 4 weeks, and 3 months:
Adverse events, cancer recurrence, n: exercise group: 2 control group: 1 |
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Notes | Country: Canada Funding: BFonds de Recherche en Sante du Quebec, Investigator Award |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | sequence of randomization was "computer generated" |
Allocation concealment (selection bias) | Low risk | "sealed envelopes, which were concealed to both kinesiologist and patient" |
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 | 4 participants from the exercise group were not included in the analyses (withdrew, n = 1; cancer recurrence, n = 2; metastatic breast cancer diagnosis, n = 1); 3 participants from the control group were not included in the analyses (withdrew, n = 2; cancer recurrence, n = 10) |
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 |