Irwin 2015.
Methods | RCT; duration: 12 months | |
Participants | Inclusion
Recruited from 5 hospitals in Connecticut, USA from June 2010‐December 2012 n = 121 (61 in exercise and 60 in usual care group). Lost funding during the study, so not all participants able to complete entire 12‐month programme. (45 participants completed programme in exercise arm vs 38 in control arm completed 12‐month programme) Mean age: exercise group: 62 ± 7 years; usual care 60.5 ± 7 years No significant differences between groups: 85% vs 84% non‐Hispanic white; 1.9 vs 1.8 years since starting AI; 52% vs 42% on pain medication; 32 vs 49% had pre‐existing arthritis |
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Interventions | Intervention
Comparator
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Outcomes | Primary outcome (Questionnaires done baseline, 3, 6, 9, 12 months)
Secondary outcome
Safety data available Collected QoL data using SF‐36, FACT‐G, FACT‐B and FACIT‐Fatigue Preplanned subgroup analysis of those with pre‐existing joint pain |
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Notes | Study funding from National Cancer Institute, Breast Cancer Research Foundation, Yale Cancer Centre, and National Center for Advancing Translational Science. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Permuted block randomization (at 1:1 ratio) with random block size was performed, stratified by joint pain before AI therapy and current bisphosphonate use" |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described in article/protocol. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel unable to be blinded due to nature of the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | PROs completed by unblinded participants. Grip strength may be influenced by motivational encouragement by assessors who are unblinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Incomplete outcome data. Quote: "Given funding cuts, the last 25 of the 121 patients recruited were enrolled into a 6 month rather than a 12 month trial. Thus their study compliance was based on the 6 month data". Dropout imbalanced between arms: 95% completed 6 months in intervention arm, vs only 82% in usual care group. 94% vs 80% at 12 months. Dropout reason not stated. |
Selective reporting (reporting bias) | Unclear risk | Protocol published prospectively with many outcomes. Most are published in the primary publication and a variety of secondary publications. Eg, QoL reported in Baglia 2019. Some primary psychological outcomes are not reported, and stiffness subscale not reported from WOMAC. Stiffness was one of the outcomes of our review. |
Adherence | Low risk | Intervention arm averaged 119 min/week of aerobic exercise, with average 70% of strength training sessions completed. |
Contamination | High risk | Increase in physical activity levels in the control arm. Women randomly assigned to exercise increased their physical activity an average of 159 min/week, compared with 49 min/week in the usual care group (P = 0.001) |
Other bias | Low risk | No other sources of bias identified |