Ebrahim 1997.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 24 months (also 12 months) | |
| Participants | Setting: London, UK Number of participants: 165 Number analysed: 102 Number lost to follow‐up: 63 Sample: community‐dwelling women Age (years): Intervention mean = 66.4 (SD 7.8), Control mean = 68.1 (SD 7.8) Sex: 100% female Inclusion criteria: postmenopausal women who had sustained a fracture in the upper arm in the past 2 years recruited from 2 East London Hospitals Exclusion criteria: women being treated with bisphosphonates, if expected survival was < 1 year, cognitive impairment, too frail to withstand brisk walking or travelling for measurements |
|
| Interventions | 1. Individual Brisk Walking: intensity progressed, monthly telephone contact, advice from nurse about general health and balanced diet, walked 40 minutes, 3 a week, 2 years 2. Control group: simple upper limb exercises, monthly telephone contact, advice from nurse about general health and balanced diet |
|
| Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) 3. Number of people who experienced 1 or more fall‐related fractures |
|
| Duration of the study | 2 years | |
| Adherence | Adherence not defined. Participation in programme reported: 1. Individual Brisk Walking group: adherence not defined, 49/81 (60.5%) continued programme, with all remaining participants exercising ≥ 40 min, 3 a week 2. Control group: adherence not defined, 48/84 (57.14%) continued programme |
|
| Notes | Source of funding: The Wolfson Family Trust Economic information: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomly assigned" using "computer generated" allocation |
| Allocation concealment (selection bias) | Unclear risk | Series of prepared envelopes but did not mention "opaque" or "sealed" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants not blind to allocated group. Research personnel were not blind to group, yet delivered the intervention to both groups and assessed fall outcome, which increases the risk of bias |
| Blinding of outcome assessment (detection bias) Falls | High risk | Falls ascertained by the same method in both groups. The research nurse delivering intervention to groups also conducted the monthly telephone calls to monitor the occurrence of falls, therefore was not blinded |
| Blinding of outcome assessment (detection bias) Fractures | Low risk | Fracutres were assessed in all groups using radiological examination, by personnel blinded to group allocation |
| Blinding of outcome assessment (detection bias) Hospital admission, medical attention and adverse events | Unclear risk | Not applicable |
| Blinding of outcome assessment (detection bias) Health related quality of life (self report) | Unclear risk | Not applicable |
| Incomplete outcome data (attrition bias) Falls and fallers | High risk | More than 20% of fall outcome data are missing (38%). Loss of fall data was unbalanced in intervention (n = 17) and control (n = 12) groups; reason for loss of fall data was unclear |
| Selective reporting (reporting bias) | Unclear risk | Minimum set of expected outcomes not reported (adverse events not reported) |
| Method of ascertaining falls (recall bias) | Unclear risk | Monthly telephone calls |