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

30 kwietnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

56

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Hiszpania
    • Pontevedra
      • A Lama, Pontevedra, Hiszpania, 36830
        • A Lama

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

Inclusion Criteria:

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

Exclusion Criteria:

  • Medical contraindication to exercise

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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
Inny: 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
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Physical Performance Short Physical Performance Battery (SPPB)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Functional Performance: Change in Timed Up and Go (TUG) Test
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline (T0) and post-intervention (8-12 weeks)
Unipodal stance or Functional Reach Test
Baseline (T0) and post-intervention (8-12 weeks)
Aerobic Capacity
Ramy czasowe: Baseline (T0) and post-intervention (8-12 weeks)
2-Minute Step Test
Baseline (T0) and post-intervention (8-12 weeks)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Completion Rate of Pressure Platform Assessments
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Vigo

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 kwietnia 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2026

Ukończenie studiów (Szacowany)

30 lipca 2026

Daty rejestracji na studia

Pierwszy przesłany

2 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

7 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 kwietnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 025/447

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

Protocol states data will not be shared with third parties

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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