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. 2019 Jan 31;2019(1):CD012424. doi: 10.1002/14651858.CD012424.pub2

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"