Dodd 2010.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 119; 44 to an exercise group that began exercise during treatment (EE), 36 to an exercise group that began exercise after treatment (CE), and 39 to the control group Study start and stop dates: 1999 to 2005 Length of intervention: 4 to 6 months Length of follow‐up: 1 year from baseline |
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Participants | Type cancer: breast, n = 112; ovarian, n = 6; colon, n = 1 Cancer stage, n (%):
Time since cancer diagnosis: not reported Time beyond active treatment: unclear Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
Gender: women Current age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race, n (%):
Education level: not reported SES, ≥ USD40,000, n (%):
Employment status, employed full or part time, n (%):
Comorbidities: not reported Past exercise history, participation in regular exercise, n (%):
On hormone therapy: not reported |
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Interventions | 80 participants assigned to the exercise intervention (44 in EE group and 36 in CE group), including:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: targeted to HR corresponding to 60% to 80% VO2 peak, and to achieve the Borg Scale of 12‐ to 14‐point level ("somewhat hard"). Frequency: 3 to 5 times per week Duration of individual sessions: 20 to 30 minutes of continuous exercise Duration of exercise program: 4 to 6 months Total number of exercise sessions: not reported, but varied Format: individual Facility: home based Professionally supervised by exercise physiologist 39 participants assigned to control group, including:
Adherence: the EE group reported an adherence rate of 73% at end of intervention and 75.7% at end of follow‐up, and the CE group reported 86.7% adherence at end of intervention Contamination of control group: not reported |
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Outcomes | No primary outcome was identified. QoL outcomes included:
Physical performance was measured using the KPS scale Outcomes were measured at baseline, 4 to 6 months (end of intervention) and 1 year:
Analyses were completed on 37 women in the EE group, 32 women in the CE group, and 37 women in the control group Subgroup analysis: none reported Adverse events:
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Notes | Country: US Funding: National Cancer Institute; Clinical & Translational Science Institute, Clinical Research Center |
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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 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 | Several participants in each of the study groups were excluded from the analyses. There was no ITT analysis and it is unclear how missing data were handled |
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 |