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

30. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

56

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

Inclusion Criteria:

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

Exclusion Criteria:

  • Medical contraindication to exercise

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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
Sonstiges: 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
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Physical Performance Short Physical Performance Battery (SPPB)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Functional Performance: Change in Timed Up and Go (TUG) Test
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline (T0) and post-intervention (8-12 weeks)
Unipodal stance or Functional Reach Test
Baseline (T0) and post-intervention (8-12 weeks)
Aerobic Capacity
Zeitfenster: Baseline (T0) and post-intervention (8-12 weeks)
2-Minute Step Test
Baseline (T0) and post-intervention (8-12 weeks)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Completion Rate of Pressure Platform Assessments
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Vigo

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

2. April 2026

Primärer Abschluss (Geschätzt)

1. Juni 2026

Studienabschluss (Geschätzt)

30. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

2. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. April 2026

Zuerst gepostet (Tatsächlich)

7. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 025/447

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Beschreibung des IPD-Plans

Protocol states data will not be shared with third parties

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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