Fall Risk, Frail Elderly
Conditions
Keywords
Frailty, Falls prevention, Older adults, Physical function, SPPB, Sit-to-Stand, Primary care physiotherapy
Brief summary
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.
Detailed description
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.
Interventions
OTHERMulticomponent Exercise Program- 1 times per week.
Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 1 times per week.
OTHERMulticomponent Exercise Program- 2 times per week.
Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 2 times per week.
Sponsors
University of Vigo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥70 years * Barthel Index ≥90 * Participation in the frailty program * Ability to provide informed consent
Exclusion criteria
* Medical contraindication to exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Instrumented Balance: Center of Pressure (CoP) Sway Area | 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 | 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. | 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 |
| Change in Physical Performance Short Physical Performance Battery (SPPB) | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Performance: Change in Timed Up and Go (TUG) Test | Baseline (T0) and post-intervention (8-12 weeks) | Time required to stand up, walk 3 meters, turn, return, and sit down. * Unit of measure: Seconds * Interpretation: Lower values indicate better performance The interpretation of TUG results depends on the population (healthy adults, older adults, clinical populations), but general reference thresholds are as follows: * Older Adults (Community-Dwelling) \< 12 seconds: Normal functional mobility 12-20 seconds: Mild impairment / increased risk of functional decline \> 20 seconds: Significant mobility impairment * Fall Risk Interpretation \> 13.5 seconds: Increased risk of falls (commonly used cut-off) Clinical Populations (frail patients) 20-30 seconds: Moderate functional limitation \> 30 seconds: Severe dependency in mobility A change of approximately ≥ 2-3 seconds is often considered clinically meaningful, depending on the population studied. |
| Functional Performance: Change in Gait Speed (4-Meter Walk Test) | Baseline (T0) and post-intervention (8-12 weeks) | Change in usual walking speed assessed over a 4-meter distance. Gait speed is calculated as distance divided by time and expressed in meters per second (m/s). Only gait speed is reported as the outcome measure. Unit of measure: meters per second (m/s). Higher values indicate better functional performance. Minimum value: 0 m/s Maximum value: Not applicable (no fixed upper limit; typically \< 2.5 m/s in adults) Interpretation: Higher values indicate better functional performance |
| Functional Performance: Change in FRAIL Scale Score | Baseline (T0) and post-intervention (8-12 weeks) | Assessment of frailty status using the FRAIL scale. * Score range: 0 to 5 * Interpretation: Higher scores indicate greater frailty * Unit of measure: Points on a scale |
| Muscle Strength: Change in Handgrip Strength | Baseline (T0) and post-intervention (8-12 weeks) | Assessment of maximal isometric grip strength using a dynamometer. * Unit of measure: kg (or Newtons, depending on device) * Interpretation: Higher values indicate greater strength |
| Muscle Strength: Change in 30-Second Sit-to-Stand Test | Baseline (T0) and post-intervention (8-12 weeks) | * Unit of measure: Repetitions * Interpretation: Higher values indicate better lower limb strength |
| Balance | Baseline (T0) and post-intervention (8-12 weeks) | Unipodal stance or Functional Reach Test |
| Aerobic Capacity | Baseline (T0) and post-intervention (8-12 weeks) | 2-Minute Step Test |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORLorenzo Justo-Cousiño, PhD
Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Pontevedra, Spain
Outcome results
None listed