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

Iwamoto 2009.

Methods Study design: RCT
Number of study arms: 2
Length of follow‐up: 5 months
Participants Setting: Tokyo, Japan
Number of participants: 68
Number analysed: 67
Number lost to follow‐up: 1
 Sample: volunteer patients from Department of Orthopaedic Surgery (2 hospitals) and Orthopaedic Clinics (3)
 Age (years): mean 76.4 (SD 5.6), range 66 ‐ 88
 Sex: 90% female
Inclusion criteria: aged > 50 years; fully ambulatory; able to complete physical assessments
 Exclusion criteria: using walking aids; severe kyphosis due to osteoporotic vertebral fractures; acute illness; severe cardiovascular disease
Interventions 1. Group‐based balance and gait training: supervised exercise programme (calisthenics, balance, muscle power, walking ability training); 30 minutes, 3 a week for 20 weeks
2. Control group: no exercise
Outcomes 1. Number of people who experienced 1 or more falls (risk of falling)
Duration of the study 20 weeks
Adherence Adherence not defined. Completion rate:
1. Group‐based balance and gait training group: all participants completed the 5‐month trial; adherence not defined
2. Control group: 33/34 participants completed trial
Notes Source of funding: Keio University School of Medicine
Economic information: not reported
Place of residence not specified, i.e. not specifically community‐dwelling, but not preventing falls in hospital or specifically in an institution
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The subjects were randomly divided into two groups ..."
Allocation concealment (selection bias) Unclear risk Quote: "The subjects were randomly divided into two groups ..."
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Participants and personnel unblinded but impact of unblinding unknown
Blinding of outcome assessment (detection bias) 
 Falls High risk Assessor blinding is unclear, but assume obtaining "information regarding falls and fractures .... every week by directly asking the participants" occured for exercise participants during class and control participants were assessed at 2½ and 5 months
Blinding of outcome assessment (detection bias) 
 Fractures High risk Fractures appear to be self‐reported with no confirmation from medical records
Blinding of outcome assessment (detection bias) 
 Hospital admission, medical attention and adverse events Unclear risk Method of ascertaining adverse events unclear
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 Low risk Less than 20% of fall outcome data are missing (2%). Only missing data are from 1 control participant due to noncompliance
Selective reporting (reporting bias) High risk Falls were measured, but number of fallers not reported
Method of ascertaining falls (recall bias) High risk Quote: "The incidence of fall and fracture … was assessed 2.5 and 5 months after the start of the trial. In particular, information regarding falls and fractures was obtained every week by directly asking the participants." No mention of diaries or calendars. Retrospective recall. Possibly only the intervention group were asked every week (at class) and remainder at 2½ and 5 months.