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Clinical Efficacy of a Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) in Frail Older Adults Within Primary Care: A Randomized Controlled Trial (FRAIL+AP)

7. juni 2026 opdateret af: Alberto Bermejo Franco, Universidad Europea de Madrid

Frailty is a multidimensional clinical syndrome associated with increased vulnerability to adverse health outcomes in older adults. Despite strong evidence supporting multicomponent exercise interventions, their implementation in primary care settings remains limited.

This randomized controlled trial aims to evaluate the efficacy of the FRAIL+AP program, which integrates Comprehensive Geriatric Assessment (CGA) with a 12-week multicomponent exercise intervention, including visual-spatial gait retraining using the Tapiz Fisior system.

The study will assess whether this intervention improves frailty status, physical performance, and functional independence, while reducing falls among community-dwelling older adults compared to standard care.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Frailty is a prevalent geriatric syndrome characterized by decreased physiological reserve and increased vulnerability to adverse health outcomes, including falls, disability, hospitalization, institutionalization, and mortality. The Canary Islands have one of the highest rates of frailty and pre-frailty among community-dwelling older adults in Spain, highlighting the need for effective and scalable interventions within primary care settings.

Comprehensive Geriatric Assessment (CGA) is considered the gold standard for identifying multidimensional health needs in older adults and for guiding individualized care plans. In parallel, multicomponent exercise programs incorporating strength, balance, endurance, and flexibility training have demonstrated effectiveness in improving physical function and reducing frailty-related impairments. However, challenges remain regarding the implementation of these interventions in routine primary care practice.

The FRAIL+AP study is a multicenter, randomized controlled trial designed to evaluate the clinical efficacy of a primary care-based intervention combining Comprehensive Geriatric Assessment, health education, and a supervised multicomponent exercise program in frail and pre-frail older adults. The intervention also incorporates visual-spatial gait retraining using the Tapiz Fisior system, a structured floor-grid tool aimed at improving gait control, balance, coordination, and fall prevention.

A total of 200 community-dwelling adults aged 70 years and older will be recruited from five primary care centers in Tenerife, Spain. Eligible participants will be randomly allocated in a 1:1 ratio to either the intervention group or a control group receiving usual care. The intervention will last 12 weeks and will consist of supervised and home-based exercise sessions, together with educational activities focused on healthy lifestyles, nutrition, frailty awareness, and fall prevention.

Primary outcomes include changes in frailty status assessed by the FRAIL Scale and physical performance measured using the Short Physical Performance Battery (SPPB). Secondary outcomes include incidence of falls, pain perception, mood, functional independence, nutritional status, handgrip strength, healthcare resource utilization, and comorbidity measures. Outcomes will be assessed at baseline and one week after completion of the intervention by blinded evaluators.

The study aims to determine whether the FRAIL+AP protocol can improve physical performance, reduce frailty, and support healthy aging through an integrated and scalable model that can be implemented within routine primary care services.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Spanien
    • Santa Cruz de Tenerife
      • Tacoronte, Santa Cruz de Tenerife, Spanien, 38350
        • Rekruttering
        • Centro de Salud Tacoronte
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Carlos Eusebio Esparza Ferrera, Physiotherapist

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

Beskrivelse

Inclusion Criteria:

  • Community-dwelling adults aged 70 years or older.
  • Ability and willingness to provide written informed consent.
  • Medical clearance to participate in low-to-moderate intensity physical exercise.
  • Presence of frailty or pre-frailty defined by meeting at least two of the following criteria:
  • Functional independence sufficient to participate in the intervention (Barthel Index >80.
  • FRAIL Scale score ≥ 1.
  • Short Physical Performance Battery (SPPB) score < 10.
  • Gait speed < 0.8 m/s.
  • Timed Up and Go (TUG) test > 12 seconds.
  • Registered at one of the participating primary care centers.

Exclusion Criteria:

  • Absolute contraindications to physical exercise, including recent acute myocardial infarction, unstable angina, severe uncontrolled cardiovascular disease, or severe uncorrected aortic stenosis.
  • Severe cognitive impairment preventing comprehension of study procedures or exercise instructions.
  • Severe psychiatric disorders interfering with participation.
  • Absence of a legally authorized representative when required.
  • Severe uncontrolled behavioral disturbances.
  • Any acute or chronic medical condition considered by the investigators to make participation unsafe.

Discontinuation Criteria:

  • Failure to attend the initial mandatory health education workshop.
  • Attendance at fewer than 6 of the 12 scheduled supervised exercise sessions.
  • Development of an acute medical condition that results in a temporary or permanent contraindication to physical activity.
  • Participant withdrawal of informed consent.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: FRAIL+AP Program
Participants receive a 12-week intervention consisting of a Comprehensive Geriatric Assessment (CGA), health education, and a multicomponent exercise program combining strength, balance, mobility, flexibility, and visual-spatial gait retraining using the Tapiz Fisior system. The intervention includes one supervised session and one home-based session per week.
Adfærdsmæssigt: FRAIL+AP Program
A 12-week multicomponent intervention including Comprehensive Geriatric Assessment, health education, strength training, balance exercises, mobility training, flexibility exercises, and visual-spatial gait retraining using the Tapiz Fisior system. Participants attend one supervised session and perform one home-based session per week.
Aktiv komparator: Usual Care
Participants receive standard primary care follow-up according to the Canary Health Service guidelines, including routine medical care and general lifestyle recommendations, without participation in the FRAIL+AP structured exercise program.
Andet: Usual Care
Standard primary care management according to regional healthcare guidelines without structured exercise intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in frailty status measured by the FRAIL Scale
Tidsramme: Baseline and 12 weeks
Change in FRAIL Scale score from baseline to the end of the 12-week intervention. The FRAIL Scale classifies participants as robust (0), pre-frail (1-2), or frail (3-5).
Baseline and 12 weeks
Change in physical performance measured by the Short Physical Performance Battery (SPPB)
Tidsramme: Baseline and 12 weeks
Change in SPPB score from baseline to the end of the 12-week intervention. The SPPB evaluates balance, gait speed, and lower-extremity strength, with higher scores indicating better physical performance.
Baseline and 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Falls
Tidsramme: Baseline and 12 weeks
Number of falls recorded during the study period using participant diaries and verified through electronic medical records.
Baseline and 12 weeks
Musculoskeletal Pain Intensity
Tidsramme: Baseline and 12 weeks
Change in perceived musculoskeletal pain measured using a 10-cm Visual Analog Scale (VAS), with higher scores indicating greater pain intensity.
Baseline and 12 weeks
Mood and Affective Status
Tidsramme: Baseline and 12 weeks
Change in depressive symptoms measured using the 15-item Geriatric Depression Scale (GDS-15), with higher scores indicating greater depressive symptomatology.
Baseline and 12 weeks
Functional Independence
Tidsramme: Baseline and 12 weeks
Change in functional independence measured using the Barthel Index. Higher scores indicate greater independence in activities of daily living.
Baseline and 12 weeks
Nutritional Status
Tidsramme: Baseline and 12 weeks
Change in nutritional status measured using the Mini Nutritional Assessment (MNA), a validated tool for identifying malnutrition and risk of malnutrition in older adults.
Baseline and 12 weeks
Handgrip Strength
Tidsramme: Baseline and 12 weeks
Change in upper-limb muscle strength measured by handgrip dynamometry. The highest value obtained from standardized testing procedures will be recorded.
Baseline and 12 weeks
Comorbidity Burden
Tidsramme: Baseline and 12 weeks
Change in clinical comorbidity status assessed using the Charlson Comorbidity Index.
Baseline and 12 weeks
Healthcare Resource Utilization
Tidsramme: Baseline and 12 weeks
Healthcare utilization assessed through review of electronic medical records, including primary care visits, emergency department attendance, hospital admissions, and other healthcare contacts during the study period.
Baseline and 12 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Universidad Europea de Madrid

Efterforskere

  • Ledende efterforsker: Ángel Moisés Reyes Abreu, Registered Nurse, Centro médico Tacoronte. Adress: Carr. Gral. del Nte., 5, 38350 Tacoronte, Santa Cruz de Tenerife
  • Studieleder: Alberto Bermejo Franco, PhD (Physiotherapy), Universidad Europea de Madrid. Adress: C/ Tajo, S/N. 28670 Villaviciosa de Odón (Madrid)

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)

28. maj 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

7. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHUC_2026_19
  • PIFIISC 25/28 (Andet bevillings-/finansieringsnummer: Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Data sharing plans have not yet been finalized. Any future sharing of de-identified individual participant data will be considered in accordance with ethical, legal, and institutional requirements.

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Kliniske forsøg med FRAIL+AP Program

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