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

Twiss 2009.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Participants Baseline characteristics
  • 100% women

  • Age (yr): 58.69 (SD 7.5)


Inclusion criteria: ≥ 12 months postmenopausal, aged 35–75 years, history (≥ 6 months' post‐treatment) of stage 0, I or II breast cancer, osteopenia or osteoporosis as defined by a bone mineral density T score of –1.0 or less at hip, lumbar spine or forearm, reside within 100 miles of research sites at Omaha, Lincoln, Kearney, and Scottsbluff Nebraska, physicians permission to participate
Exclusion criteria: recurrence of breast cancer; currently taking hormone therapy, bisphosphonates, glucocorticosteroids, or other drugs affecting bone density; currently engaging in strength exercises; body mass index ≥ 35 kg/m², serum calcium, creatinine or thyroid‐stimulating hormone outside normal; active gastrointestinal problems or other conditions that prohibited strength exercises; intake of vitamin D or risedronate
Group differences: not reported
Interventions Usual care
  • Not stated


Exercise
  • 2 × 30–45 minutes for 32 weeks at home. Gym‐based programme for 72 weeks (session duration and number of sessions per week not reported)

Outcomes Tandem balance
  • Outcome type: continuous

  • Reporting: full

  • Scale: time

  • Unit of measure: seconds

  • Direction: lower was better


Falls
  • Outcome type: adverse event

  • Reporting: full

  • Scale: numbers

  • Direction: lower was better

Identification Sponsorship source: funded by "NINR"
Country: USA
Setting: exercises delivered at home then at fitness centre. Testing a hospitals or rehabilitation centres at 4 sites.
Comments: none
Author's name: Nancy Waltman
Institution: University of Nebraska Medical Center College of Nursing, Omaha
E‐mail: nwaltman@unmc.edu
Address: University of Nebraska Medical Center, College of Nursing, Commerce. Court PO Box 880220, Lincoln, NE, USA
Notes All participants were grouped together at baseline
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Authors stated that participants were randomly allocated; however, did not detail the sequence generation process
Allocation concealment (selection bias) Unclear risk No information provided regarding allocation concealment to allow a judgement to be made
Blinding of participants and personnel (performance bias)
All outcomes High risk No attempt to blind either the participants (understandably) or the personnel assessing outcome. Those involved in the intervention appeared to be making outcome assessments. It was possible that knowledge of the intervention group could have biased outcome assessments
Blinding of outcome assessment (detection bias) High risk Outcome assessors appeared to be involved in delivery of the intervention
Incomplete outcome data (attrition bias)
All outcomes Low risk 26/249 women randomised into the study did not complete the 24‐month testing. The dropout rate of the intervention group was comparable to that of the control group (14 vs 12) and reasons for withdrawal did not indicate potential for bias
Selective outcome reporting (reporting bias) Unclear risk Protocol not available, insufficient evidence to make a decision
Size of study Unclear risk Between 50 and 199 participants per treatment arm
Other sources of bias Low risk Study appeared free of other sources of bias