Mock 1994.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 14; 9 to the exercise group and 5 to the control group Study start and stop dates: not reported Length of intervention: duration of chemotherapy (4 to 6 months) Length of follow‐up: 1 month postchemotherapy |
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Participants | Type cancer: breast cancer Time since cancer diagnosis: not reported Time in active treatment: enrolled prior to beginning chemotherapy Inclusion criteria:
Eligibility criteria related to interest or ability, or both, to exercise:
Exclusion criteria:
Gender: female Current age: mean (range), 44 (34 to 61) years Age at cancer diagnosis: not reported Ethnicity/race: 93% Caucasian, 7% Other Education level: mean years of education, 16 years SES: not reported Employment status: 78% employed Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported |
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Interventions | 9 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: not reported Frequency: 4 or 5 times per week Duration of individual sessions: 10 to 45 minutes and 5 minutes cool‐down Duration of exercise program: 4 to 6 months Total number of exercise sessions: varied Format: individual Facility: home Not professionally led Adherence: "...not all equally successful in maintaining an active exercise program, but all exercised for a minimum of 30 minutes three or more times per week throughout the program" 5 participants assigned to control group, including:
Contamination of control group: "two did not exercise at all, and three exercised less than 30 minutes twice per week" |
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Outcomes | No primary outcome was identified. QoL outcomes included:
Outcomes were measured at baseline, mid‐treatment (about 3 months), and end of the intervention (about 6 months):
Subgroup analysis: none Adverse events: "No walkers suffered any known physical injury or bleeding episode related to the walking program" |
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Notes | Country: US Funding: American Cancer Society—Massachusetts Division, American Nurses Foundation, Massachusetts Nurses Foundation, Boston College |
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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) | Unclear risk | Whether the treatment assignment was concealed from study personnel and participants was not described |
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 | Low risk | All study participants were included in the analyses in the originally assigned treatment group |
Selective reporting (reporting bias) | High risk | Only some of the symptoms from the SAS were included in the table; others were summarized only using generalities in the text "infrequently" |
Other bias | Low risk | The trial appears to be free of other problems that could put it at a high risk of bias |