Vollmers 2018.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Study grouping: parallel group |
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Participants |
Baseline characteristics 100% women Usual care
Exercise
Inclusion criteria: primary breast cancer, aged 18–75 years and primary paclitaxel treatment for 12 weeks. Exclusion criteria: existing cardiopulmonary diseases (e.g. New York Heart Association class III, myocardial infarction < 3 months), renal insufficiency (glomerular filtration rate < 30 mL/minute), neurological diseases (e.g. multiple sclerosis, other neuropathies), metabolic diseases (e.g. diabetes mellitus; severe obesity (body mass index > 35 kg/m²) and the extensive consumption of alcohol either currently or in the past Group differences: none |
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Interventions |
Usual care
Exercise
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Outcomes |
Postural sway
Chair rising test
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Identification |
Sponsorship source: none declared Country: Germany Setting: University Hospital Comments: none Author's name: Paul Lennart Vollmers Institution: University Hospital for Women, Kiel Address: Arnold‐Heller‐Strabe 3, Haus 14, 24105 Kiel, Germany |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information regarding randomisation process. Stated participants were randomised (via 1:1 randomisation) but did not specify how this occurred |
Allocation concealment (selection bias) | Unclear risk | No reporting on process of allocation (i.e. no information about who or how) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded to their allocation |
Blinding of outcome assessment (detection bias) | Unclear risk | No mention of whether assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Relatively large proportion withdrawn after enrolment (7/43); not accounted for in the analysis. No intention‐to‐treat analysis. No data presented on participants who dropped out |
Selective outcome reporting (reporting bias) | Unclear risk | Protocol not available, insufficient evidence to make a decision |
Size of study | High risk | Fewer than 50 participants per treatment arm |
Other sources of bias | High risk | Baseline imbalance between intervention and control groups for the balance variable |