Payne 2008.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 20; 10 to the exercise group and 10 to the control group Study start and stop dates: 9‐month period but dates not reported Length of intervention: 14 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: breast cancer Time since cancer diagnosis: not reported Time beyond active treatment: not reported Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
Gender: female Current age, mean (SD) years: 64.7 (6.3) years Age at cancer diagnosis: not reported Ethnicity/race, n (%): 18 (90%) Caucasian and 2 (10%) African‐American Education level, n (%): 11th or 12th grade education, 5 (25%); some college level education, 7 (35%); college degree or higher level of education, 8 (40%) SES, household income, n (%): ≤ USD20,000, 4 (20%); USD20,001 to USD40,000, 5 (25%); USD40,001 to USD60,000, 4 (20%); > USD60,000, 6 (30%); refused to answer 1 (5%) Employment status, n (%): employed, 3 (15%); homemaker, 1 (5%); retired, 11 (55%); other employment status, 2 (10%); did not provide employment information, 3 (15%) Comorbidities: not reported Past exercise history: not reported On hormone therapy: all used tamoxifen, anastrozole, or letrozole |
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Interventions | 10 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: moderate Frequency: 4 times per week Duration of individual sessions: 20 minutes Duration of exercise program: 14 weeks Total number of exercise sessions: 56 sessions Format: individual Facility: home Not professionally led, but explained by study coordinator 10 participants assigned to the control group, including:
Adherence: 9 out of the 10 women completed the study, adherence data on number of sessions completed are not specified Contamination of control group: not reported |
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Outcomes | No primary outcome was identified. QoL outcomes included:
Physiologic outcomes included:
Outcomes were measured at baseline, 12 weeks, and 14 weeks:
Subgroup analysis: none reported Adverse events: none reported |
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Notes | Country: US Funding: NIH/National Institute of Nursing Research |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Generation of allocation 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 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 was no description on how missing data were handled. Participants in each group withdrew from the study |
Selective reporting (reporting bias) | Low risk | There is no evidence of selective reporting of outcomes |
Other bias | High risk | Small sample size and low recruitment rate can put study at risk of bias |