Twiss 2009.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Study grouping: parallel group |
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Participants |
Baseline characteristics
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 |
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Interventions |
Usual care
Exercise
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Outcomes |
Tandem balance
Falls
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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 |
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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 |