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Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) for Frail Older Adults in Primary Care (FRAIL+AP)

4. august 2026 oppdatert av: Alberto Bermejo Franco

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Spania
    • Santa Cruz de Tenerife
      • Tacoronte, Santa Cruz de Tenerife, Spania, 38350
        • Rekruttering
        • Centro de Salud Tacoronte
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Carlos Eusebio Esparza Ferrera, Physiotherapist

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Annen: Usual Care
Standard primary care management according to regional healthcare guidelines without structured exercise intervention.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in frailty status measured by the FRAIL Scale
Tidsramme: Baseline and 12 weeks
Change in FRAIL Scale score from baseline to 12 weeks. The FRAIL Scale ranges from 0 to 5, with higher scores indicating greater frailty (0 = robust, 1-2 = pre-frail, 3-5 = frail).
Baseline and 12 weeks
Change in physical performance measured by the Short Physical Performance Battery (SPPB)
Tidsramme: Baseline and 12 weeks
Change in the total Short Physical Performance Battery (SPPB) score from baseline to 12 weeks. The SPPB total score ranges from 0 to 12, with higher scores indicating better physical performance.
Baseline and 12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
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
Musculoskeletal Pain Intensity
Tidsramme: Baseline and 12 weeks
Change in musculoskeletal pain intensity measured using the Numeric Rating Scale (NRS). The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate 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). The GDS-15 total score ranges from 0 to 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. The Barthel Index total score ranges from 0 to 100, with higher scores indicating 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). The MNA total score ranges from 0 to 30, with higher scores indicating better nutritional status. Scores <17 indicate malnutrition, 17-23.5 indicate risk of malnutrition, and 24-30 indicate normal nutritional status.
Baseline and 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alberto Bermejo Franco

Etterforskere

  • Hovedetterforsker: 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)

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

28. mai 2026

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

7. juni 2026

Først innsendt som oppfylte QC-kriteriene

7. juni 2026

Først lagt ut (Faktiske)

11. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CHUC_2026_19
  • PIFIISC 25/28 (Annet stipend/finansieringsnummer: Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC))

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

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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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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