LaStayo 2017.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
|
Participants | Setting: Utah, USA Number of participants: 134 Number analysed: 112 Number lost to follow‐up: 22 Sample: community‐dwelling Age (years): mean 76.1 (SD 7.18) Sex: 65% female Inclusion criteria: at least 65 years of age or older; had experienced at least 1 fall in the previous 12 months; community‐dwelling; ambulatory with a gait speed ranging from of 0.42 to 1.3 m/s; able to recall all 3 items (or 1 to 2 items with a normal clock drawing test) on the Mini‐CogTM instrument for dementia screening; managing 2 or more co‐morbid conditions, though cleared by their physician to participate in a 60‐minute (with rests) multicomponent exercise fall reduction programme (MCEFRP) Exclusion criteria: progressive diagnosed neurologic disease (e.g. Parkinson’s, multiple sclerosis, Guillain‐Barre, Alzheimers); any dystrophies or rheumatologic conditions that primarily affects muscle (e.g. muscular dystrophy, polymyalgia rheumatica); already participated in a MCEFRP or if they were currently performing (or had performed) regular (3 times a week) aerobic (defined as hiking, fast‐walking, jogging, running swimming or cycling) or resistance (defined as weight training with bands, cable, free‐weights or weight‐machines) exercise over the past 12 months; any of the absolute contraindications for a MRI scan |
|
Interventions | Participants trained for 60 minutes per session, 3 times a week for 3 months as part of the multicomponent exercise fall reduction program that included aerobic training (recumbent trainer, cycle erg or treadmill), flexibility exercise, 15 ‐ 20‐minute individualised balance exercises, upper‐limb resistance training and lower‐limb resistance training The 2 lower‐limb resistance training programmes were: 1) Traditional (TRAD) resistance exercise: 3 sets of 15 repetitions of a seated bilateral leg‐press exercise at 70% 1 RM. Also, standing multidirectional straight‐leg exercises with a weighted cuff placed just proximal to the ankle. The training loads for this exercise were increased as tolerated every 2 weeks, provided the participants could complete 3 sets of 15 repetitions with appropriate form 2) Resistance exercise by negative, eccentrically‐induced, work (RENEW): progressive resistive eccentric exercise of the knee and hip extensor muscles using a recumbent stepper‐ergometer. The duration of each resistance training session was progressively increased to a maximum 15‐minute duration during weeks 5 – 12 |
|
Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) |
|
Duration of the study | 52 weeks | |
Adherence | All participants completed the prespecified requisite minimum 18 MCEFRP sessions and ≥ 90% adhered to at least 29 of the 36 exercise sessions | |
Notes | Source of funding: National Institute of Aging of the National Institutes of Health Economic information: not reported Email communication regarding fall data, response received, data not included in review |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "A randomisation process with blocks of ten insured equivalency in the number of subjects adn the same proportion of men and women were assigned into each of the groups" |
Allocation concealment (selection bias) | Unclear risk | Allocation not specified |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding not specified. Assume participants and presonnel not blinded. Impact of non‐blinding is unknown |
Blinding of outcome assessment (detection bias) Falls | High risk | Assessors were not blinded to group |
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 (16%). Missing data were not balanced between the RENEW (n = 14) and traditional (n = 8) groups, with more participants dropping out in the first 3 months in the RENEW group (9 dropouts compared with 4 dropouts). The reasons for the dropouts are not clear |
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 | From 0 ‐ 3 months intervention personnel asked about falls at weekly intervention sessions. 4 ‐ 12 months falls were recorded by monthly stamped postcards, with telephone contact if a fall was reported or postcards were not returned |