Loudon 2014.
Methods | Study design: multi‐centre RCT Numbers allocated, 28; 15 to exercise intervention, 13 to control Study start: February 2011; stop date: May 2011 Length of intervention: 8 weeks Length of follow‐up: at 12 weeks Country: Tasmania, Australia |
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Participants | Baseline data available for 12 in intervention and 11 in control: Age, years (mean SD):
Stage, n (%):
Inclusion criteria: • Stage I unilateral secondary lymphoedema of the arm, as defined by the International Society of Lymphology and confirmed by a professional lymphoedema therapist • Completed treatment for breast cancer (surgery, radiotherapy, and chemotherapy) at least 6 months previously • Over 18 years of age • Sufficient English literacy to provide informed consent Exclusion criteria: • Recurrent cancer • Infection • Receiving complex lymphoedema therapy • Pregnancy • Wore a pacemaker, which would affect bioimpedance spectroscopy (BIS) readings • Severe psychological illness |
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Interventions | 15 participants assigned to exercise intervention:
Adherence: Attendance at group yoga sessions was high (97%), as was self‐reported compliance with the home practice DVD (86%). 13 participants assigned to control:
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Outcomes | Primary outcome:
Secondary outcomes:
Numbers of participants assessed:
Adverse events: No adverse events were attributable to the yoga or to the control intervention. |
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Notes | Trial registration link: none available Trial authors contacted: no Intention‐to‐treat analysis: no https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000202965 Funding: Swan Research Institute (SRI) and Faculty of Health Sciences Seed Funding, UTAS. Equipment was provided by Flinders University and University of Tasmania. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “randomisation based on a computer‐generated random number system” |
Allocation concealment (selection bias) | Low risk | “An individual not associated with the trial will perform the randomisation”. “Group notification will be in a sealed envelope given to women after completion of the baseline measurement”. |
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 participants. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | “Measurements, based on validated instruments and protocols, were taken by trained researchers blinded to the group allocation and previous results”. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only those who completed post‐intervention and 1‐month‐after‐cessation assessments were included in analysis. |
Selective reporting (reporting bias) | Low risk | No selective reporting of outcomes is apparent. |
Other bias | Low risk | Trial appears to be free of other problems that could put it at high risk of bias. |