Smulders 2010.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
|
Participants | Setting: Nijmegan, Netherlands Number of participants: 96 Number analysed: 92 Number lost to follow‐up: 4 Sample: identified from databases of DXA scans, mail out to members of Dutch Osteoporosis Patient Council; advertising Age (years): mean 71.0 (SD 4.7) Sex: 94% female Inclusion criteria: community‐dwelling; aged > 65; osteoporosis (DXA; femoral neck or lower‐back T score ≤ −2.5); ≥ 1 falls in previous year; able to walk 15 minutes without walking device Exclusion criteria: severe cardiac, pulmonary, or musculoskeletal disorders or disorders associated with higher fall risk (e.g. neurologic disorders) |
|
Interventions | 1. Group‐based balance and gait training using an obstacle avoidance course: 11 sessions between 1 ‐ 2½ hours including education, balance, gait training using obstacle course, for 5½ weeks 2. Control: usual care |
|
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 4. Health‐related quality of life |
|
Duration of the study | 52 weeks | |
Adherence | Adherence measured by session attendance 1. Group‐based balance and gait training using an obstacle avoidance course group: 93% attendance at total number of sessions. More than half (53%) of the participants did not miss a session |
|
Notes | Source of funding: Center for Organization of Healthcare Research Economic information: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "After a baseline assessment M1, the researcher performed block randomization using non–see‐through envelopes. The probability of allocation to the exercise group was independent of recruitment method" |
Allocation concealment (selection bias) | Unclear risk | Non‐see‐through envelopes but not sequentially numbered |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel not blinded to allocated group but impact of non‐blinding unclear |
Blinding of outcome assessment (detection bias) Falls | Low risk | Quote: "Fall calendars were scored by an independent researcher who was blinded to group allocation" |
Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Method of reporting fractures is unclear |
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) | High risk | Participants not blind to group allocation |
Incomplete outcome data (attrition bias) Falls and fallers | Low risk | Less than 20% of fall data were missing (4%) with missing data balanced between groups and balanced reasons for missing data |
Selective reporting (reporting bias) | Unclear risk | Minimum set of expected outcomes not reported (adverse events not reported) |
Method of ascertaining falls (recall bias) | Low risk | Quote: "After the intervention had ended, participants registered their falls for 1 year on fall calendars that had to be returned every month… When no fall calendar was received within 2 weeks after the start of the month, the participant was reminded by telephone" |