Gine‐Garriga 2010.
| Methods | Type of study: RCT | |
| Participants | Number of participants randomised: 51 Losses: at end of intervention 6 control, 4 exercise; at 6 months FU a further 12 control, 4 exercise Age: 84 (± 2.9) yr Sex: 31 women, 20 men Health status as defined by authors: frail Residential status of participants: community‐dwelling Setting:Spain Inclusion: one randomly selected primary health care centre, 80 to 90 years Exclusion:unable to walk, undergoing an exercise program, severe dementia (not able to understand or follow verbal commands), or had had a stroke, hip fracture, myocardial infarction or hip‐ or knee‐ replacement surgery within the previous 6 months |
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| Interventions | EXERCISE GROUP (GBFT) (n = 26): 1 day of balance‐based activities and 1 day of lower body strength‐based exercises; both were combined with function focused activities. Balance activities were designed to challenge the visual (e.g. eyes open/closed), vestibular (e.g., move head), and somatosensory (e.g., stand on foam) systems. Balance exercises included function‐focused activities such as walking with obstacles, while wearing standard sunglasses (worn over corrective lenses as needed) to mimic a semidark environment, walking while carrying a package that obstructed the view of the feet, and walking while picking up objects from the floor. Lower body exercises included functional tasks such as rising from a chair, stair climbing, knee bends, floor transfer, lunges, leg squat, leg extension, leg flexion, calf raise, and abdominal curl using ankle weights. initially 8 reps increased to 15. The load was increased 0.5 kg when a participant could perform 15 repetitions at a lower perceived exertion intensity, up to a maximum of 2 kg. CONTROL GROUP (n = 25): met once a week for health education meetings, four health education sessions of 60 min over the 12 visits. Duration and intensity: 45 mins twice a week for 12 weeks Supervisor: investigator (not stated) Supervision: group Setting: primary care facility |
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| Outcomes | Gait speed 8 m of a 12‐m (m/s) Modified Timed Up‐and‐Go Test (includes kicking a ball) (s) Semi tandem stance (s) Tandem Stands (s) Single‐Leg stand (s) Compliance/adherence: Exercise group: compliance 90%; all participants were compliant with the exercise prescription except for 1 woman who required rest (sitting on a chair) after each exercise during the first 3 weeks. Control Group: compliance 76% Adverse events: No adverse events reported. |
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| Notes | Sample‐size calculations: thirty‐eight participants (19 per group) were needed to detect a 20% improvement in the rapid‐gait test, at a power of 80% and an α of .05, and a 20% dropout rate. Forty‐four participants (22 per group) were needed to detect a 15% improvement in the stand‐up test, analysed with the same criteria as the rapid‐gait test. These data produce extreme results in the meta‐analyses. The SE may have been reported in error. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A computer‐generated algorithm was used |
| Allocation concealment (selection bias) | Low risk | Personnel who maintained the randomisation log were not involved in screening, testing, or training procedures |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient reporting of attrition/exclusions to permit judgement |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
| Other bias | Low risk | The study appears to be free of other sources of bias |
| Blinding (participant) | Unclear risk | Not possible |
| Blinding (assessor) | Low risk | An assistant who had no role in the intervention and was unaware of the study hypothesis and of the participants’ group assignments |
| Were the treatment and control group comparable at entry? | Low risk | No differences reported on baseline characteristics with a potential to influence the effect of the intervention |
| Was the surveillance active, and of clinically appropriate duration (i.e. at least 3 months post intervention)? | Low risk | Immediately post intervention and six months after the end of the program |