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. 2020 Jan 29;2020(1):CD012988. doi: 10.1002/14651858.CD012988.pub2

Nyrop 2017.

Methods RCT, duration: 6‐week intervention, plus 6‐month follow‐up
Participants Inclusion
  • Stage 0‐III BC, age > 21 years (although 16%, n = 10, had stage IV disease at baseline)

  • Compliant on AI ≥ 4 weeks

  • ≥ 3/5 score on PROMIS pain intensity‐short form

  • Exercising ≤ 150 min/week


Exclusion
  • Concurrent chemotherapy or radiation therapy


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
Interventions Intervention
  • Home‐based, self‐directed walking, 6 weeks (Walk with Ease‐Breast Cancer programme)

  • Given written information, workbook encouraging at least 150 min exercise/week, walking as comfortable pace

  • Physical activity log

  • No contact with investigators during the 6‐week intervention period


Comparator
  • Waiting list control‐ no intervention. Asked to await further contact from the research team at 6 weeks after study baseline

  • After 6 weeks given same materials and instructions as intervention group

Outcomes (Assessed at baseline, 6 weeks and 6 months after intervention. Waiting list control group had an extra questionnaire 6 weeks after completing intervention)
  • Physical activity levels (min/week)

  • VAS for pain, stiffness, fatigue

  • WOMAC index

  • FACT‐G

  • RAI

  • Adherence to AI

  • ASE scale

  • Outcome expectations from exercise

  • Self‐efficacy for physical activity

  • Feasibility, tolerability, adverse events

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