Buchner 1997.
| Methods | Study design: RCT Number of study arms: 2 for analysis Length of follow‐up: 25 months | |
| Participants | Setting: Seattle, USA Number of participants: 105 Number analysed: 100 Number lost to follow‐up: 5 Sample: random sample of HMO members (FICSIT intervention groups only) Age (years): mean 75 Sex: 51% female Inclusion criteria: aged 68 ‐ 85; unable to do 8‐step tandem gait test without errors; below 50th percentile in knee extensor strength for height and weight Exclusion criteria: active cardiovascular, pulmonary, vestibular, and bone disease; positive cardiac stress test; body weight > 180% ideal; major psychiatric illness; active metabolic disease; chronic anaemia; amputation; chronic neurological or muscle disease; inability to walk; dependency in eating, dressing, transfer or bathing; terminal illness; inability to speak English or complete written forms |
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| Interventions | Randomised into 7 groups: 6 intervention groups (3 FICSIT trial ‐ group‐based stationary cycling, group‐based strength training, group‐based combined endurance and strength training; and 3 MoveIT trial), and 1 control group. This paper reports on the 3 FICSIT groups and the control group
1. Group‐based stationary cycling: stationary cycles used for arms and legs, supervised classes; 1 hour (30 ‐ 35 minutes endurance exercise), 3 a week for 6 months followed by unsupervised exercise
2. Group‐based strength training: weight machines used for upper and lower body (2 sets of 10 reps per set, 50 ‐ 60% 1 RM for set 1 and 75% of 1 RM for set 2), supervised classes; 1 hour, 3 a week for 6 months followed by unsupervised exercise 3. Group‐based combined endurance and strength training: 20 minutes of endurance training and 1 set of strength training exercises (75% 1 RM) 4. Control: usual activity levels but "allowed to exercise after 6 months" |
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| Outcomes | 1. Rate of falls
2. Number of people who experienced 1 or more falls (risk of falling) "A priori decision" to report fall outcomes for "any exercise" (all 3 exercise groups combined) compared with control group |
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| Duration of the study | Up to 100 weeks, median 72 weeks | |
| Adherence | Exercise groups: 14 dropouts (19%), participants who remained in the study attended 95% sessions Control group; 1 dropout (3%) |
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| Notes | Source of funding: National Institute on Aging, Centers for Disease Control and Prevention, Department of Veterans Affairs Economic information: Healthcare service costs: hospitalised control participants more likely to have hospital costs > USD 5000 (P < 0.05); no significant difference in ancillary outpatient costs between groups at 7 ‐ 18 months Seattle FICSIT trial. Only 1.3% of original sample randomised. Falls not primary outcome. Other outcomes assessed at end of intervention (6 months) then "control group allowed to exercise after 6 months" (7/30 participants did). Cost analysis reported in primary reference | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised, quote: "using a variation of randomly permuted blocks" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| 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 | Unclear risk | Falls reported by participants who were aware of their group allocation. Quote: "Most study outcomes were measured by blinded examiners..." but unclear whether this applies to personnel carrying out telephone follow‐up of falls |
| 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 outcome data are missing (5%). Unbalanced losses between intervention groups (n = 2 in each of the 3 groups) and control (n = 0) group. Reason for missing data unclear |
| 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 | Falls reported immediately by mail, also monthly postcard return; telephone follow‐up if no postcard received |