Dimeo 2004.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 72; 34 to the exercise group and 35 to the control group Study start and stop dates: not reported Length of intervention: 3 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: lung cancer (n = 27), gastrointestinal cancer (n = 42) Cancer stage, n:
Time since cancer diagnosis, mean (SD) days:
Time beyond active treatment, mean (SD) days:
Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
Gender:
Current age, mean (SD) years
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level: not reported SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported |
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Interventions | 34 participants assigned to the exercise group, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: 80% of the maximal HR in the stress test Frequency: 5 times per week Duration of session: 30 minutes Duration of exercise program: 3 weeks Total number of exercise sessions: 15 Format: group Facility: facility‐based Professionally led: not clear, but supervised by an physician in the same room Adherence: not reported 35 participants assigned to the control group, including:
Contamination of control group: not reported |
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Outcomes | Outcome: QoL outcomes, using:
Subgroups: differences between participants with lung and gastrointestinal tumors. No differences found, so combined data from both groups Outcomes were measured at baseline and 3 weeks (end of the intervention):
Adverse events: 3 participants with thrombosis and infection in the exercise group |
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Notes | Country: Germany Setting: Laboratory Funding: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number list |
Allocation concealment (selection bias) | Low risk | "The randomisation sequence was concealed until assignment of interventions" |
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 | Low risk | 3 patients in the exercise group were admitted to the hospital for the treatment of a concurrent disease (thrombosis, infection). Data for the 3 patients who did not complete the questionnaire after the intervention were evaluated using the "worst rank assumption" |
Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
Other bias | High risk | Demographic information not reported |