Gill 2016.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 42 months | |
Participants | Setting: USA Number of participants: 1635 Number analysed: 1635 Number lost to follow‐up: 0 Sample: community‐dwelling Age (years): Intervention mean = 78.7 (SD 5.2), control mean = 79.1 (SD 5.2) Sex: 67% female Inclusion criteria: aged 70 ‐ 89 years, < 20 minutes/week structured exercise in past month and < 125 minutes/week of moderate physical activity, short physical performance battery score ≤ 9 out of 12, could walk 400 m in 15 minutes or less without assistance or aid, no major cognitive impairment, safely participate in the intervention as determined by medical history, physical exam, and electrocardiography Exclusion criteria: not reported |
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Interventions | 1. Group‐ and home‐based balance, strength, flexibility and walking training: individualised and progressed, used ankle weights for strength training; 1‐hour sessions, 2 a week, home exercises 3 ‐ 4 a week for 24 ‐ 42 months depending on time of enrolment 2. Control group: attended weekly health education group for 26 weeks and monthly sessions thereafter, plus 5 ‐ 10 minutes stretching exercises |
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Outcomes | 1. Number of people who experienced 1 or more fall‐related fractures 2. Number of people who experienced 1 of more falls requiring hospital admission 3. Number of people who died |
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Duration of the study | Up to 168 weeks | |
Adherence | Adherence measured by attendance at sessions 1. Group‐ and home‐based balance, strength, flexibility and walking training group: attended mean of 63% of scheduled sessions, median 71% (interquartile range 50 ‐ 83%) 2. Control: attended mean of 73% of the scheduled sessions, median 82% (63 ‐ 90%) |
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Notes | Source of funding: National Institute of Health, National Institute of Aging, National Heart, Lung and Blood Institute Economic information: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomised..through a secure web based data management system using a permuted block algorithm (with random block lengths) stratified by field center and sex" |
Allocation concealment (selection bias) | Low risk | Quote: "Secure web based data management system" |
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 | Unclear risk | Not applicable |
Blinding of outcome assessment (detection bias) Fractures | Low risk | Question by blinded assessor: Quote: “did a doctor tell you that you fractured or broke a bone?” If yes, Quote: "Two experts blinded to group randomization subsequently reviewed and adjudicated independently relevant medical records, including those from all hospital admissions.” A fall‐related fracture required the fulfilment of 4 prespecified criteria |
Blinding of outcome assessment (detection bias) Hospital admission, medical attention and adverse events | Low risk | Quote: "Two experts blinded to group randomization subsequently reviewed and adjudicated independently relevant medical records, including those from all hospital admissions.” |
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 | Unclear risk | No fall data |
Selective reporting (reporting bias) | High risk | The question "have you fallen?" was asked but was not prespecified |
Method of ascertaining falls (recall bias) | High risk | Questioned by blinded assessors every 6 months: Since (last visit date), did a doctor tell you that you fractured or broke a bone? (If yes) Did you break a bone as a result of a fall? and Other than the conditions we just asked you about, were you admitted to a hospital overnight for any other reasons since (last visit date)? Since (last visit date), have you fallen? Did this fall result in an inability to leave home for at least one week? |