Halvarsson 2016.
Methods | Study design: RCT Number of study arms: 3 Length of follow‐up: 3 months | |
Participants | Setting: Stockholm, Sweden Number of participants: 96 Number analysed: 69 Number lost to follow‐up: 27 Sample: community‐dwelling Age (years): Intervention mean 76 (range 67 ‐ 86), Control mean 75 (range 66 ‐ 84) Sex: 98% female Inclusion criteria: age ≥ 65 years afraid of falling or having experienced at least one fall in the last 12 month s, or both, and independence in ambulation Exclusion criteria: fractures during the last year, MMSE score < 24, severely decreased vision, or other diseases or constraints that might interfere with participation in the exercise programme |
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Interventions | 1. Group‐based progressive balance training: supervised and tailored exercises, 45 minute sessions, 3 a week for 12 weeks 2. Group‐based progressive balance training plus walking: supervised and tailored exercises, 45‐minute sessions, 3 a week for 12 weeks, plus walking (preferably with poles) for ≥ 30 minutes, 3 a week for 12 weeks 3. Control group: no intervention, offered the same balance training at the end of the study |
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Outcomes | 1. Number of people who experienced 1 or more falls (risk of falling) | |
Duration of the study | 60 weeks | |
Adherence | Adherence measured in sessions attended Participants attending ≥ 66% sessions included in follow‐up. Adherence rate to the training sessions was 89% (range 66 ‐ 100%) 2. Group‐based progressive balance training plus walking: all except 1 participant fulfilled the added physical activity intervention |
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Notes | Source of funding: Stockholm County Council, Karolinska Institutet (ALF), Swedish Research Council, Health Care Sciences Postgraduate School at Karolinska Institutet
Economic information: not reported 3‐month data used due to proportion of fallers not being clear for longer follow‐up period |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Subjects were randomised...using web‐based software" |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
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 | Quote: "The test leaders were blinded to group allocation at baseline; however, it was no longer possible after baseline testing, because some of the test leaders were also involved in the balance training" |
Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Not applicable |
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 | Unclear risk | Less than 20% of fall outcome data are missing (3%). Loss of fall data was unbalanced in balance (n = 9) balance + walking (n = 13) and control (n = 5) groups; reason for loss of fall data was unbalanced |
Selective reporting (reporting bias) | High risk | Falls measured but number of falls not reported. |
Method of ascertaining falls (recall bias) | High risk | Quote: "Participants reported .. at each follow‐up whether they had fallen during the time since the previous follow‐up session". Follow‐up was at 3, 9 and 15 months |