Multicomponent Versus Balance Exercise for Fallrelated Physical Function in Older Adults With Recurrent Falls: a Singlecenter, Threearm Randomized Controlled Trial With 6month Followup
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
To compare the short-term effects and 6-month durability of supervised multicomponent exercise, balance exercise alone, and fall-prevention education on balance, strength, walking performance, and health-related quality of life in older adults with recurrent falls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older,
- •more than two falls during the preceding year,
- •unimpaired Timed Up and Go performance,
- •Beck Depression Inventory score consistent with safe participation
排除标准
- •Contraindication to exercise,
- •fracture,
- •active joint disease or infection,
- •pulmonary disease,
- •uncontrolled diabetes mellitus or hypertension,
- •congestive heart failure, or
- •serious neurological disease.
研究组 & 干预措施
Multicomponent exercise
Supervised balance-coordination exercises followed by elastic-band strengthening of the quadriceps, hamstrings, hip abductors, and hip adductors, plus mini-squats. Sessions were delivered 3 days per week for 8 weeks.
干预措施: Multicomponent exercise (Behavioral)
Balance exercise
Supervised balance-coordination tasks, warm-up, and stretching only, without resistance exercises or mini-squats. Sessions were delivered 3 days per week for 8 weeks.
干预措施: Balance exercise (Behavioral)
Control
Standardized education on reducing fall risk only, without any supervised exercise program.
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: Baseline, 8 weeks, and 6 months
A 14-item performance measure scored from 0 to 56; higher scores indicate better balance.
Functional balance assessed by the Berg Balance Scale (BBS)
时间窗: Baseline, 8 weeks (immediately post-treatment), and 6 months (follow-up)
A 14-item performance-based measure used to evaluate static and dynamic balance capacity. The total score ranges from 0 to 56, where higher scores indicate better functional balance and lower fall risk.
次要结局
- Handgrip strength(Baseline, 8 weeks, and 6 months.)
- 10-m walk time(Baseline, 8 weeks, and 6 months.)
- Short Form-36 (SF-36)(Baseline, 8 weeks, and 6 months.)
- Maximal handgrip strength measured using a hand dynamometer(Baseline, 8 weeks (post-treatment), and 6 months (follow-up))
- Gait speed assessed by the 10-Meter Walk Test (10MWT)(Baseline, 8 weeks (post-treatment), and 6 months (follow-up))
- Health-related quality of life assessed by the 36-Item Short Form Survey (SF-36)(Baseline, 8 weeks (post-treatment), and 6 months (follow-up))
研究者
Nilay Sahin
Prof. Dr.
Balikesir University