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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent Exercise Program- 1 times per week. | Other | Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 1 times per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Performance Short Physical Performance Battery (SPPB) | 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.
| Baseline (T0) and post-intervention (8-12 weeks) |
| Change in Fall Risk | 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) | Baseline (T0) and post-intervention (8-12 weeks) |
| Change in Instrumented Balance: Center of Pressure (CoP) Sway Area | -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 | Baseline (T0) and post-intervention (8-12 weeks) |
| Change in Instrumented Balance: Center of Pressure (CoP) Velocity | 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 | Baseline (T0) and post-intervention (8-12 weeks) |
| Change in Instrumented Balance:Center of Pressure (CoP) Path Length. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Performance: Change in Timed Up and Go (TUG) Test | Time required to stand up, walk 3 meters, turn, return, and sit down.
The interpretation of TUG results depends on the population (healthy adults, older adults, clinical populations), but general reference thresholds are as follows:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion Rate of Pressure Platform Assessments | Proportion of participants who successfully complete the pressure platform assessment protocol. Completion is defined as the participant performing all required trials according to the study protocol. Unit of measure: Percentage (%). Higher values indicate better feasibility. | Baseline (T0) and post-intervention (8-12 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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The study population consists of older adults aged 70 years and above who are currently enrolled in the frailty prevention program within the Galician public health system. These individuals have been identified as frail or pre-frail through routine primary care screening and demonstrate sufficient functional capacity, as indicated by a Barthel Index score of 90 or higher, reflecting independence in basic activities of daily living.
Eligible participants must be able to understand the study procedures and provide informed consent, ensuring that they can engage safely and meaningfully in the intervention. All participants are actively involved in the structured frailty program delivered by primary care physiotherapy services, which focuses on preventing functional decline and reducing the risk of falls.
Individuals will be excluded if they present with any medical contraindication to exercise.
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Justo-Cousiño, PhD | Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Pontevedra, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A Lama | A Lama | Pontevedra | 36830 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31343601 | Background | Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230. | |
| 31233069 | Background | Beckwee D, Delaere A, Aelbrecht S, Baert V, Beaudart C, Bruyere O, de Saint-Hubert M, Bautmans I. Exercise Interventions for the Prevention and Treatment of Sarcopenia. A Systematic Umbrella Review. J Nutr Health Aging. 2019;23(6):494-502. doi: 10.1007/s12603-019-1196-8. |
| Label | URL |
|---|---|
| World Health Organization. World report on ageing and health. Geneva: World Health Organization; 2015. | View source |
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Protocol states data will not be shared with third parties
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Multicomponent Exercise Program- 2 times per week. | Other | Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 2 times per week. |
|
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 |
| Baseline (T0) and post-intervention (8-12 weeks) |
| Baseline (T0) and post-intervention (8-12 weeks) |
| Functional Performance: Change in Gait Speed (4-Meter Walk Test) | 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 | Baseline (T0) and post-intervention (8-12 weeks) |
| Functional Performance: Change in FRAIL Scale Score | Assessment of frailty status using the FRAIL scale.
| Baseline (T0) and post-intervention (8-12 weeks) |
| Muscle Strength: Change in Handgrip Strength | Assessment of maximal isometric grip strength using a dynamometer.
| Baseline (T0) and post-intervention (8-12 weeks) |
| Muscle Strength: Change in 30-Second Sit-to-Stand Test |
| Baseline (T0) and post-intervention (8-12 weeks) |
| Balance | Unipodal stance or Functional Reach Test | Baseline (T0) and post-intervention (8-12 weeks) |
| Aerobic Capacity | 2-Minute Step Test | Baseline (T0) and post-intervention (8-12 weeks) |
| Number of Attempts Required for Successful Assessment | Number of attempts needed to obtain valid measurements. • Unit of measure: Count | Baseline (T0) and post-intervention (8-12 weeks) |
| Technical Issues During Assessment | Number of technical incidents encountered during measurement. • Unit of measure: Count | Baseline (T0) and post-intervention (8-12 weeks) |
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