Crowley 2003.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 22; 13 to the exercise group and 9 to the control group Study start and stop dates: not reported Length of intervention: 13 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: breast cancer Cancer stage, n (%): Stage I, 13 (59.1%); Stage II, 9 (40.9%) Time since cancer diagnosis: not reported Time in active treatment: completed surgery, initiating adjuvant chemotherapy of four 3‐week cycles of adriamycin and cytoxan Inclusion criteria:
Eligibility criteria related to interest or ability, or both, to exercise:
Exclusion criteria:
Gender: female Current age, range: 36 to 58 years Age at cancer diagnosis: not reported Ethnicity/race, n (%): Caucasian, 21 (95.5%); African American, 1 (4.5%) Education level, n (%): high school, 1 (4.5%); vocational school, 1 (4.5%); some years of college, 6 (27.3%); college graduate, 14 (63.6%) SES: not reported Employment status, n (%): unemployed, 3 (13.6%); full‐time, 14 (63.6%); part‐time, 5 (22.7%) Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported Menopausal status, n (%): premenopausal, 12 (54.5%); postmenopausal, 10 (45.5%) |
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Interventions | 13 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of the experimental exercise intervention:
Frequency: 3 to 5 times per week Duration of individual sessions: not reported Duration of exercise program: 13 weeks Total number of exercise sessions: 39 to 65 sessions over 13 weeks Format: individual Facility: home Professionally led in that education provided by an exercise physiologist twice during the program, once at the beginning and once during week 8 Adherence: average days walked per week was 3.66 days or 113 minutes per week 9 participants assigned to control group, including:
Contamination of control group: average days walked per week was 1.79 days or 53 minutes per week |
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Outcomes | Primary outcomes: non‐HRQoL and HRQoL outcomes including:
Outcomes were measured at baseline, 7 weeks, and 13 weeks:
Subgroup analysis: none reported Adverse events: not reported |
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Notes | Country: US Funding: Sigma Theta, Rho Chapter, Oncology Nursing Society Foundation, Pharmacia & Upjohn |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table used, with consecutive numbers on the table used with those numbers ending in an even integer assigned to the exercise group, and numbers ending in an odd integer assigned to the control group |
Allocation concealment (selection bias) | Low risk | Each random number placed in an envelope that was sealed and consecutively numbered on the outside |
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 | Allocation to the intervention was not concealed from the study personnel |
Incomplete outcome data (attrition bias) All outcomes | High risk | Analyses were not conducted on an ITT basis and the treatment of missing data was not described. It is unclear how much attrition occurred in the trial |
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 |