Kovacs 2012.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 41 (21 in the intervention group; 20 in the usual activity group) Number analyzed: 41 Number of centers: 1 Date of first enrollment: February 2010 Length of follow‐up: 8 weeks Sample size estimation: the author reported this study had small sample size which reduced the statistical power of their analyses. Based on their results, a post hoc power analysis indicated that at least 171 participants in each group would require to achieve a statistical power of 80%. |
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Participants | Country: Hungary Age: mean 70 years (SD: 7 years) Sex: 100% female Key inclusion criteria: living in nursing homes with age‐related visual impairment, being female. Key exclusion criteria: being totally blind, had lived in the nursing home for less than 2 months, being unable to walk around their own residence, progressively being unable to walk around their own residence, progressively increasing severity of neurological, and unstable cardiovascular diseases that would limit participation in exercise program, planned moving away from the nursing home during the study period and participated in an exercise program including balance exercise within 6 months Comparability of baseline characteristics: comparable |
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Interventions |
Behavioral intervention #1: participants joined twice a week in a multimodal exercise program for 30 min and twice a week in the standard osteoporosis exercise program. The multimodal exercise program included balance and strength exercises based on Otago Exercise Program. Control intervention #2: participants joined in the standard osteoporosis exercise program alone for four times a week in 30 min. |
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Outcomes | Primary outcome: Berg Balance Scale at 6 months, Secondary outcomes: (1) Timed Up and Go, (2) Barthel activity of daily living, (3) number of fallers, (4) mean length of time to first fall in weeks. |
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Notes | Funding sources: the study was not sponsored Statistical analyses: appropriate Subgroup analyses: not reported Registration: not available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Blocked randomization was performed (with a block size of 4). |
Allocation concealment (selection bias) | Low risk | Assignment was numbered opaque identical sealed envelopes. The envelopes were prepared by an independent physiotherapist. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Therapist and participants were not blinded to group allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The outcome assessor was uninformed about group allocation and was not involved in proceedings of the exercise programs. Participants were asked not to reveal details of their treatment to the outcome assessor. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed 8‐week of follow‐up. No participants were excluded from the study. |
Selective reporting (reporting bias) | Low risk | Outcomes specified in the study protocol were reported |
Other bias | Low risk | No other sources of bias identified |