Observational Study of Functional Changes and Fall Risk in Older Adults Participating in a Multicomponent Frailty and Falls Prevention Program in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Physical Performance Short Physical Performance Battery (SPPB)
研究概览
简要总结
This prospective observational study aims to describe changes in physical function and fall risk in adults aged 70 years and older participating in a routine multicomponent frailty and falls prevention program in primary care. Participants are evaluated before and after the intervention, and additional postural control variables are recorded using a pressure platform without modifying routine clinical care.
详细描述
Frailty is a clinical condition associated with increased vulnerability to adverse health outcomes, including falls, disability, and mortality. In the Galician public health system, a structured frailty and falls prevention program is implemented within primary care physiotherapy services.
This study is designed as a prospective, longitudinal observational study with pre-post evaluation under real-world clinical conditions, without modifying clinical decision-making or healthcare organization.
Participants aged 70 years and older enrolled in the routine program undergo baseline (T0) and post-intervention (T1) assessments after 8 weeks. The intervention consists of a multicomponent exercise program including strength, balance, and functional training.
The primary objective is to describe changes in physical function and fall risk. Secondary objectives include the characterization of participants, analysis of adherence, recording of adverse events, and evaluation of the feasibility and utility of pressure-platform-based balance assessment.
Additional functional variables (muscle strength, aerobic capacity, and clinical balance tests) are included as part of the standardized functional assessment protocol implemented in routine care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥70 years
- •Barthel Index ≥90
- •Participation in the frailty program
- •Ability to provide informed consent
排除标准
- •Medical contraindication to exercise
研究组 & 干预措施
Frailty Program Participants- 1 day/week exercise program
Adults aged ≥70 years with preserved basic functional independence (Barthel Index ≥90) participating in a routine multicomponent exercise program for frailty and fall prevention in primary care. The participants of this group will attend one multicomponent exercise session per week
干预措施: Multicomponent Exercise Program- 1 times per week. (Other)
Frailty Program Participants- 2 day/week exercise program
Adults aged ≥70 years with preserved basic functional independence (Barthel Index ≥90) participating in a routine multicomponent exercise program for frailty and fall prevention in primary care. The participants of this group will attend two multicomponent exercise session per week
干预措施: Multicomponent Exercise Program- 2 times per week. (Other)
结局指标
主要结局
Change in Physical Performance Short Physical Performance Battery (SPPB)
时间窗: Baseline (T0) and post-intervention (8-12 weeks)
Change in Short Physical Performance Battery (SPPB) total score. The SPPB is a composite measure of lower extremity function including balance, gait speed, and chair stand tests. * Score range: 0 to 12 * Interpretation: Higher scores indicate better physical performance * Unit of measure: Points on a scale
Change in Fall Risk
时间窗: Baseline (T0) and post-intervention (8-12 weeks)
Change in fall risk indicators based on clinical assessment (falls history and gait impairment). Minimum value: 0 Maximum value: Not applicable (composite clinical indicator; upper bound not fixed) Interpretation: Higher values indicate worse outcome (greater fall risk)
Change in Instrumented Balance: Center of Pressure (CoP) Sway Area
时间窗: Baseline (T0) and post-intervention (8-12 weeks)
-Change in Center of Pressure (CoP) Sway Area Change in postural sway area measured using a pressure platform. The Center of Pressure (CoP) sway area represents the area covered by the CoP trajectory during quiet standing. Unit of measure: square millimeters (mm²). Higher values indicate worse postural stability. Minimum value: 0 mm² Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability
Change in Instrumented Balance: Center of Pressure (CoP) Velocity
时间窗: Baseline (T0) and post-intervention (8-12 weeks)
Change in Center of Pressure (CoP) Velocity Change in mean velocity of center of pressure displacement. • Unit of measure: mm/s Minimum value: 0 mm/s Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability
Change in Instrumented Balance:Center of Pressure (CoP) Path Length.
时间窗: Baseline (T0) and post-intervention (8-12 weeks)
Change in Center of Pressure (CoP) Path Length Change in total trajectory length of center of pressure. • Unit of measure: mm Minimum value: 0 mm Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability
次要结局
- Muscle Strength: Change in 30-Second Sit-to-Stand Test(Baseline (T0) and post-intervention (8-12 weeks))
- Functional Performance: Change in Timed Up and Go (TUG) Test(Baseline (T0) and post-intervention (8-12 weeks))
- Functional Performance: Change in Gait Speed (4-Meter Walk Test)(Baseline (T0) and post-intervention (8-12 weeks))
- Functional Performance: Change in FRAIL Scale Score(Baseline (T0) and post-intervention (8-12 weeks))
- Muscle Strength: Change in Handgrip Strength(Baseline (T0) and post-intervention (8-12 weeks))
- Balance(Baseline (T0) and post-intervention (8-12 weeks))
- Aerobic Capacity(Baseline (T0) and post-intervention (8-12 weeks))
研究者
Lorenzo Antonio Justo Cousino, PhD
physical therapist
University of Vigo