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. 2018 Oct 15;2018(10):CD011687. doi: 10.1002/14651858.CD011687.pub2

Vollmers 2018.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Participants Baseline characteristics
100% women
Usual care
  • Age (yr): 52.39 (SD 10.14)


Exercise
  • Age (yr): 48.56 (SD 11.94)


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
Interventions Usual care
  • Received an instruction sheet informing them about the current state of science concerning physical activity in malignant diseases and suggesting a regular physical activity designed autonomously by the participants


Exercise
  • 2 × physical training and sensorimotor exercises per week for 18 weeks

Outcomes Postural sway
  • Outcome type: continuous

  • Scale: distance

  • Unit of measure: centimetres

  • Direction: lower was better

  • Data value: change from baseline


Chair rising test
  • Outcome type: continuous

  • Scale: number of repetitions

  • Direction: higher was better

  • Data value: change from baseline

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
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