Nyrop 2017.
Methods | RCT, duration: 6‐week intervention, plus 6‐month follow‐up | |
Participants | Inclusion
Exclusion
Identified through review of appointment schedule at BC clinic in tertiary care hospital. Recruited between February 2014‐August 2015 n = 62 (31 in exercise, 31 in waiting list group) Median age: 63.8 ± 8.3 years Intervention group had more prior use of tamoxifen (11 vs 5) and vitamin D supplement (28 vs 19); more AI non‐compliance in control group (forgets once a week = 2 vs 9). Baseline joint symptoms balanced |
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Interventions | Intervention
Comparator
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Outcomes | (Assessed at baseline, 6 weeks and 6 months after intervention. Waiting list control group had an extra questionnaire 6 weeks after completing intervention)
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Notes | Study funding from National Cancer Institute | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "Randomized", however statements indicating serious problems ‐ "misrandomised", "inadvertent randomisation errors". Unclear what the errors were however. Imbalances in baseline demographics, which may be a reflection of selection bias. |
Allocation concealment (selection bias) | High risk | No information provided regarding allocation concealment. 5/62 participants were "mis‐randomised". It is unclear whether this was a result of the randomisation process, or allocation process. To be identified as being "mis‐randomised", it indicates that the allocations were not concealed from investigators. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind this intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | All outcomes were PROs, completed by unblinded participants. |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT analysis prospectively planned. However 23% of intervention arm did not complete 6‐week data, vs 6% control arm. Only 77% completed 6‐month data, but no mention about dropout between arms. No description of reason for not completing 6‐week or 6‐month questionnaires |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Adherence | Low risk | Mean walking time in min/week at end of 6 weeks intervention: 108.7 for intervention arm (aim was 150 min/week) |
Contamination | Low risk | Mean increase in activity time in min/week between baseline and 6 weeks was 76.21 in intervention arm, and 10.52 in the waiting list control arm. The study authors did not collect information on the type or intensity of exercise that these women engaged in, only the number of min/week. |
Other bias | Low risk | No other sources of bias identified |