Adamsen 2009.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 269; 135 to the exercise group and 134 to the control group Study start and stop dates: participants recruited from March 2004 to March 2007 Length of intervention: 6 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: various Participants had 21 different cancer diagnoses, including 17 solid tumors (i.e. cancer of the breast, bowel, ovaries, testes, esophagus, brain, cervix, pharynx, pancreas, stomach, and other), and 4 hematologic malignancies (i.e. Hodgkin lymphoma, NHL(Non‐Hodgkin’s lymphoma), acute leukemia, and chronic leukemia) Time since cancer diagnosis, median (range) days:
Time beyond active treatment: not reported Inclusion criteria:
Eligibility criteria related to interest, ability to exercise, or both:
Exclusion criteria:
Gender, n (%):
Current age, mean (SD) years
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level; completed secondary school or higher, n (%)
SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history; physical activity level pre‐illness, n (%)
On hormone therapy: not reported |
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Interventions | 135 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of the exercise intervention: the intervention activities were equivalent to a total of 43 metabolic equivalent of task (MET) hours per week Frequency: 9 hours per week Duration of individual sessions: 90 minutes for high intensity, 30 minutes for low‐intensity exercise Duration of exercise program: 6 weeks Total number of exercise sessions: 24 sessions (3 sessions per week for 6 weeks) Format: group Facility: facility based Professionally led: professionally led by trained nurse specialists and physical therapists Adherence: 70.8% 134 participants assigned to control group, including:
Contamination of control group: not reported |
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Outcomes | Primary outcome included:
Other outcomes included subscales of the QLQ C‐30, including:
Additional HRQoL outcomes included subscales from the MOS SF‐36, including:
Outcomes were measured at baseline and at 6 weeks:
Subgroup analysis: none conducted or specified Adverse events: not reported |
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Notes | Country: Denmark Funding: The Lundbeck Foundation, The Novo Nordic Foundation, The Egmont Foundation, The Danish Cancer Society, The Svend Andersen Foundation, The Aase and Ejnar Danielsen Foundation, The Beckett Foundation, The Wedell‐Wedellsborg Foundation, The Hede Nielsen Family Foundation, The Gangsted Foundation, Copenhagen University Hospital |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was done by computer (CITMAS) |
Allocation concealment (selection bias) | Low risk | The allocation sequence was executed by the clinical research unit |
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 | Low risk | Missing outcome data were assumed to be missing at random |
Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
Other bias | High risk | Since the control group was allowed to engage in or increase levels of physical activity, this could bias the effect of the overall intervention. Further, it is unclear whether there was a possibility of contamination of the control group |