Dodd 2010.
Methods | RCT, 3 groups Study start and stop dates: 1999 to 2006 Length of intervention: 1 year Length of follow‐up: end of intervention |
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Participants | 119 participants randomised, majority with breast cancer (n = 112), but people with ovarian and colorectal cancer also included, undergoing chemotherapy, Karnofsky score > = 60. Excluded if they were having concurrent radiation therapy, and if pain intensity score greater than 3 | |
Interventions |
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Outcomes | Primary outcomes:
Secondary outcomes:
Outcomes were measured at time point: baseline (T1: the week before the second chemotherapy treatment), at the end of cancer treatment (T2: 4 to 6 months after T1), and at the end of the study (T3: approximately 1 year after the start of T1). Adverse events: hip pain, sciatica (n = 16), arm discomfort (n = 4), knee discomfort (n = 10), ankle discomfort (n = 3), and foot discomfort (n = 8) |
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Notes | Funding: National Cancer Institute (CA83316), and the Clinical Translational Research Institute, Clinical Research Center (CTSI‐CRC) (Dodd 2010) Conflicts of interest: The authors declared no potential conflicts of interest in 2 related publications |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Reported as randomised, but method not described |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants All outcomes | High risk | Not done |
Blinding of personnel/care providers All outcomes | High risk | Not reported. Comment: probably not done |
Blinding of outcome assessment (detection bias) Fitness outcomes | Low risk | Cardiopulmonary exercise testing was performed in the exercise physiology lab by laboratory staff blinded to the participant’s group assignment |
Blinding of outcome assessment (detection bias) All outcomes except fitness outcomes | High risk | Not reported for other outcomes. Comment: probably not done or self reported items |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐out:
ITT, no imputation |
Selective reporting (reporting bias) | High risk | Cardiopulmonary fitness was tested but not reported as an outcome. It was unclear if cardiorespiratory fitness was a predefined outcome or only measured to individualise the exercise prescription. In 1 of 5 related publications, a quality of life questionnaire was mentioned (MQOLS‐CA), but no results were reported in any publication. Outcomes were not reported completely, and could not be extracted for use in a meta‐analysis |
Group similarity at baseline | Low risk | "The three groups of patients did not differ significantly in any of the demographic, disease, or treatment characteristics on entry into the study" |
Adherence | High risk | Group 1 (exercise during and after adjuvant treatment) reported an adherence rate of 73% at T2 and 75.7% at T3 |
Contamination | High risk | 44% of group 2 (exercise after adjuvant treatment) reported meeting ACSM 1998 guidelines (aerobic activities 3x/week, for 20‐minute duration, and at a moderate intensity) at T1, by T2 group 2 had decreased to 27%. 34% of group 3 (no exercise) reported meeting minimum criteria at T1, this decreased to 31% at T2. |