Baruth 2013.
| Methods | Study design: single‐centre RCT Number randomised: 32; 20 to intervention, 12 to control Study start: not reported; stop date: not reported Length of intervention: 12 weeks Length of follow‐up: to end of intervention Country: USA |
|
| Participants | Age, years (mean SD):
Stage, n (%):
Inclusion criteria: • Given a diagnosis of stage I‐III cancer, had completed adjuvant treatment within the previous 12 months, and were postmenopausal • Free of cardiovascular disease and major orthopaedic limitations • Not regularly active (< 5 days/week) |
|
| Interventions | 20 participants assigned to exercise intervention:
Adherence:
12 participants assigned to control:
Contamination of control group: not reported |
|
| Outcomes | Outcomes:
Numbers of participants assessed:
Adverse events: none reported |
|
| Notes | Trial registration link: none available Trial authors contacted: yes, for additional data (means and SDs for outcomes), but trial authors did not reply Intention‐to‐treat analysis: no Funding: supported by the US Army, Grant # DAMD17‐01‐1‐0628 |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Participants were randomized 2:1 (intervention: control)". It is unclear how the allocation sequence was generated. |
| Allocation concealment (selection bias) | Unclear risk | Whether treatment assignment was concealed from study personnel and participants was not described. |
| 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 | Unclear risk | Blinding of outcome assessments was not described. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Post‐test data at 12 weeks were collected on 94% of participants; only completers were analysed. |
| Selective reporting (reporting bias) | High risk | Physical activity data post intervention were not reported. |
| Other bias | Low risk | Trial appears to be free of other problems that could put it at high risk of bias. |