Mock 2005.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 119; 60 to the exercise group and 59 to the control group Study start and stop dates: recruitment between 1998 and 2001 Length of intervention: for the duration of treatment, 6 weeks if radiation therapy or 3 to 6 months if chemotherapy Length of follow‐up: to end of the intervention |
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Participants | Type cancer: breast cancer Stage, %
Time since cancer diagnosis: not reported Time in active treatment: initiating adjuvant therapy Inclusion criteria:
Eligibility criteria related to interest or ability, or both, to exercise:
Exclusion criteria:
Gender: female Current age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race, % Caucasian:
Education level, years of education, mean (SD) years:
SES: not reported Employment status: 73% employed Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported Adjuvant treatment: radiation therapy, 58%; chemotherapy, 42% |
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Interventions | 60 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: target HR range of ~ 50% to 70% of maximum HR Frequency: 5 or 6 times per week Duration of individual sessions: 45 minutes Duration of exercise program: 6 weeks for radiation or 3 to 6 months for chemotherapy Total number of exercise sessions: varied Format: individual Facility: home Not professionally led Adherence: defined as engaging in ≥ 60 minutes of aerobic activity for at least 67% of the duration of the trial: 39/54 (72%) adhered 59 participants assigned to control group, including:
Contamination of control group: defined as exceeding 45 minutes of aerobic activity weekly for 67% of the duration of the trial: 33/54 (61%) were not contaminated; 39% were contaminated |
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Outcomes | Primary outcome:
Other outcomes included
Outcomes were measured at baseline and end of the intervention:
Subgroup analysis: high walkers (>60 minutes per week in ≥ 3 sessions) versus low walkers (< 60 minutes per week or not at all) Adverse events: not reported |
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Notes | Country: US Funding: Fatigue Initiative in Research and Education multi‐institutional award from the Oncology Nursing Society Foundation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated |
Allocation concealment (selection bias) | Low risk | Number sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Owing to the nature of the intervention, it was not possible to conceal allocation to the intervention from the participants |
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 | No ITT analyses were performed and 6 participants withdrew from the exercise group and 5 form the control group |
Selective reporting (reporting bias) | Low risk | There is no evidence of 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 |