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Functional Changes and Fall Risk in Older Adults Participating in a Frailty Program (FRAIL-ALAMA)

30. april 2026 opdateret af: Lorenzo Antonio Justo Cousino, PhD, University of Vigo

Observational Study of Functional Changes and Fall Risk in Older Adults Participating in a Multicomponent Frailty and Falls Prevention Program in Primary Care

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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

56

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Pontevedra
      • A Lama, Pontevedra, Spanien, 36830
        • A Lama

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • Age ≥70 years
  • Barthel Index ≥90
  • Participation in the frailty program
  • Ability to provide informed consent

Exclusion Criteria:

  • Medical contraindication to exercise

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
Andet: Multicomponent 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.
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
Andet: Multicomponent 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Physical Performance Short Physical Performance Battery (SPPB)
Tidsramme: 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
Baseline (T0) and post-intervention (8-12 weeks)
Change in Fall Risk
Tidsramme: 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)
Baseline (T0) and post-intervention (8-12 weeks)
Change in Instrumented Balance: Center of Pressure (CoP) Sway Area
Tidsramme: 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
Baseline (T0) and post-intervention (8-12 weeks)
Change in Instrumented Balance: Center of Pressure (CoP) Velocity
Tidsramme: 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
Baseline (T0) and post-intervention (8-12 weeks)
Change in Instrumented Balance:Center of Pressure (CoP) Path Length.
Tidsramme: 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
Baseline (T0) and post-intervention (8-12 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional Performance: Change in Timed Up and Go (TUG) Test
Tidsramme: 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.
Baseline (T0) and post-intervention (8-12 weeks)
Functional Performance: Change in Gait Speed (4-Meter Walk Test)
Tidsramme: 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
Baseline (T0) and post-intervention (8-12 weeks)
Functional Performance: Change in FRAIL Scale Score
Tidsramme: 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
Baseline (T0) and post-intervention (8-12 weeks)
Muscle Strength: Change in Handgrip Strength
Tidsramme: 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
Baseline (T0) and post-intervention (8-12 weeks)
Muscle Strength: Change in 30-Second Sit-to-Stand Test
Tidsramme: Baseline (T0) and post-intervention (8-12 weeks)
  • Unit of measure: Repetitions
  • Interpretation: Higher values indicate better lower limb strength
Baseline (T0) and post-intervention (8-12 weeks)
Balance
Tidsramme: Baseline (T0) and post-intervention (8-12 weeks)
Unipodal stance or Functional Reach Test
Baseline (T0) and post-intervention (8-12 weeks)
Aerobic Capacity
Tidsramme: Baseline (T0) and post-intervention (8-12 weeks)
2-Minute Step Test
Baseline (T0) and post-intervention (8-12 weeks)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Completion Rate of Pressure Platform Assessments
Tidsramme: Baseline (T0) and post-intervention (8-12 weeks)

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)
Number of Attempts Required for Successful Assessment
Tidsramme: Baseline (T0) and post-intervention (8-12 weeks)

Number of attempts needed to obtain valid measurements.

• Unit of measure: Count
Baseline (T0) and post-intervention (8-12 weeks)
Technical Issues During Assessment
Tidsramme: Baseline (T0) and post-intervention (8-12 weeks)

Number of technical incidents encountered during measurement.

• Unit of measure: Count
Baseline (T0) and post-intervention (8-12 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Vigo

Efterforskere

  • Ledende efterforsker: Lorenzo Justo-Cousiño, PhD, Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Pontevedra, Spain

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. april 2026

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

30. juli 2026

Datoer for studieregistrering

Først indsendt

2. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 025/447

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

Protocol states data will not be shared with third parties

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