Effectiveness of a Program to Improve Balance, Mobility, and Fall Prevention in Older Adults: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Timed Up and Go (TUG)
研究概览
简要总结
This trial evaluates the effectiveness of the Otago Exercise Program in adults aged 65 and older. It compares supervised group-based training with an unsupervised home-based version of the same program. The primary aim is to assess changes in Timed Up and Go performance and gait speed before and after the intervention.
详细描述
This study investigates the effectiveness of the Otago Exercise Program (OEP) as a fall-prevention intervention in adults aged 65 years and older. The OEP is a structured, evidence-based program that includes strength, balance, and functional training exercises designed to reduce fall risk in older adults.
Participants will be randomly assigned to one of two groups. The experimental group will complete the Otago program in supervised group sessions led by a physiotherapist. The control group will perform the same Otago exercises individually at home without supervision, following standard instructions for independent implementation.
The primary objective of the study is to compare the effect of the supervised group-based program versus the unsupervised home-based program on functional mobility and gait performance. Primary outcomes include changes in the Timed Up and Go (TUG) test and gait speed measured before and after the intervention period.
This trial aims to determine whether supervised group training provides additional benefits over independent home-based execution of the Otago program in improving mobility and reducing fall risk among community-dwelling older adults.
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
- Single (Investigator)
盲法说明
Outcome assessors are blinded to group assignment. Participants and intervention supervisors are aware of the assigned intervention, but the evaluators measuring functional outcomes, including the Timed Up and Go test and gait speed, do not know which group participants belong to.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 65 years or older.
- •Community-dwelling individuals able to ambulate independently (with or without assistive devices).
- •Ability to understand instructions and follow the exercise program.
- •Able to attend assessment sessions at baseline and post-intervention.
排除标准
- •Severe cognitive impairment that limits ability to follow instructions.
- •Medical conditions contraindicating exercise (e.g., unstable cardiac disease, uncontrolled hypertension).
- •Recent lower-limb fracture or surgery within the last 6 months.
- •Neurological conditions significantly affecting gait or balance (e.g., advanced Parkinson's disease, recent stroke).
- •Participation in another structured exercise or fall-prevention program during the study period.
结局指标
主要结局
Timed Up and Go (TUG)
时间窗: Baseline and immediately after the intervention period (3 months)
Functional mobility is assessed using the Timed Up and Go test. Participants rise from a chair, walk 3 meters, turn, walk back, and sit down. The time to complete the task is recorded in seconds.
Gait Speed
时间窗: Baseline and immediately after the intervention period (3 months)
Walking speed is measured over a standardized distance (6 meters). The participant walks at a comfortable pace, and the time to complete the distance is recorded to calculate gait speed in meters per second.
次要结局
未报告次要终点
研究者
Jose Angel Delgado Gil
Physical therapist
Sanidad de Castilla y León