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Designing a Multicomponent Intervention for Improving Frailty. A Pilot Study in the Basque Country

10 juni 2026 bijgewerkt door: Biogipuzkoa Health Research Institute

This pilot study tested whether a new program for older adults with frailty could realistically be carried out in primary health care. That is why the main objective of this study was to evaluate the viability and feasibility of the newly designed frailty intervention.

People over 65 were recruited in two health centers and invited to join a 3 month program combining group exercise, a medication review by a pharmacist, and nutrition workshops. The study also collected information on mobility, strength, nutrition, mood, cognition, and quality of life. Most measures were taken at the start and again four and eight months later.

The results will help refine the program and guide the design of a larger clinical trial.

Studie Overzicht

Gedetailleerde beschrijving

The study assessed the viability and feasibility of a frailty intervention in routine clinical practice through a prospective one-arm pilot conducted in two primary care centers in Donostia (Gipuzkoa, Basque Country, Spain). Participants were adults aged 65 or older, functionally independent (Barthel >90) and classified as frail (Short Physical Performance Battery <10), who received a 12-week physical exercise program, nutritional counseling, and a pharmacological review.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

32

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Gipuzkoa
      • San Sebastián, Gipuzkoa, Spanje, 20014
        • Biogipuzkoa Health Research Institute. Primary Care Group. Epidemiology, Public Health and Primary Care Area.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • >65 years old
  • Barthel >90 points (independent)
  • Short Physical Performance Battery <10 points (frail)

Exclusion Criteria:

  • Having a terminal condition
  • Suffering from pathologies with a poor prognosis
  • Having difficulty in performing physical activities
  • Not being able to communicate fluently in Spanish
  • Presenting intellectual disabilities

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention: physical exercise, polypharmacy review and nutritional care
The arm is composed of people aged >65, independent (≥95 points) and frail (Short Physical Performance Battery <10 points). The entire arm group receives the multi-component intervention based on physical exercise, polypharmacy review and nutritional care.
Physical exercise: one-hour group sessions, twice a week for 12 consecutive weeks, at the Municipal Sports centre led by a licensed sports instructor. All sessions followed a standardized structure consisting of a warm-up phase of approximately 25 minutes, a strengthening phase of about 25 minutes adjusted to each participant's physical condition, and a final 10-minute relaxation phase including flexibility and balance exercises. Polypharmacy review: a primary care pharmacist reviewed the pharmacological treatments of each participant in order to detect potentially inappropriate prescriptions, following the STOPP/START criteria. Nutritional care: the dietary intervention consisted of three group workshops, one per month, lasting for an hour each. The three workshops, led by a nutritionist, covered the basics of healthy eating, dietary adaptations for specific conditions with recipe ideas, and strategies to prevent malnutrition and sarcopenia.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recruitment rates
Tijdsspanne: Baseline
The numbers of pre-selected participants who met the inclusion criteria and eventually agreed to participate, as well as the drop-outs and their reasons were registered.
Baseline
Time required to recruit the sample
Tijdsspanne: Baseline
The time required to recruit the sample needed for the study was recorded.
Baseline
Participants evaluation time
Tijdsspanne: From baseline to 8 months
The professionals recorded the evaluation time each participant required
From baseline to 8 months
Professionals' opinion on the difficulty and adequacy of the process
Tijdsspanne: From baseline to 8 months
Professionals who performed the baseline and follow-up assessments completed a questionnaire on the difficulty and adequacy of the process
From baseline to 8 months
Adherence to the intervention
Tijdsspanne: From baseline to 4 months
Number of attended sessions was registered
From baseline to 4 months
Participant satisfaction
Tijdsspanne: Month 4
Satisfaction was measured with an anonymous ad-hoc questionnaire, containing a total of 25 questions: The physical exercise and the nutritional components were evaluated with six questions each; general health improvements obtained during the intervention with 11; two last questions asked about the intention to keep exercising after the intervention ended and whether they would recommend this program to others.
Month 4

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Pharmacological treatments at 4 months
Tijdsspanne: From Baseline to 4 months
Change in the number of pharmacological treatments.
From Baseline to 4 months
Change from Baseline in the Health-related quality of life at 4 and 8 months
Tijdsspanne: From baseline to 8 months
The Euroqol Visual Analog Scale (EQ-VAS) was used for assessing self-reported quality of life. It is a vertical 0-100 line measuring overall health "today", with 100 being the best possible health.
From baseline to 8 months
Change from Baseline in Anxiety and Depression Status at 4 and 8 months
Tijdsspanne: From baseline to 8 months
Anxiety and depression was determined by the Goldberg Anxiety and Depression Scale. A brief screening instrument used to identify symptoms of anxiety and depression in adults. It consists of two subscales with nine items each, and the total scores help detect individuals at risk of clinically relevant emotional distress. Lower values indicate less anxiety and depression.
From baseline to 8 months
Change from Baseline in Dependence at 4 and 8 months
Tijdsspanne: From Baseline to 8 months
Lawton instrumental activities of daily living based on 8 items, with higher values indicating more independence.
From Baseline to 8 months
Change from Baseline in Social Connectedness at 4 and 8 months
Tijdsspanne: From baseline to 8 months
The Lubben Social Networks Scale is a brief, standardised tool used to assess social connectedness in older people. It measures the number and frequency of contacts within family and friends and the perception on the availability of support. The family and friends sub-scales account for a maximum of 15 points each, with the total scale score ranging from 0 to 30 points. Higher values indicate more social ties.
From baseline to 8 months
Change from Baseline in Functional Capacity at 4 and 8 months
Tijdsspanne: From baseline to 8 months
The Timed Up and Go (TUG) test was used to assess functional capacity. TUG is a simple functional assessment used to evaluate mobility, balance, and fall risk. Participants are timed while standing up from a chair, walking three meters, turning, returning, and sitting down. Shorter times (in seconds) indicate better functional mobility, while longer times suggest impaired performance.
From baseline to 8 months
Change from Baseline in Physical Activity at 4 and 8 months
Tijdsspanne: From baseline to 8 months
Physical activity was assessed using the International Physical Activity Questionnaire (IPAQ). It is a standardized instrument used to assess physical activity performed during the previous seven days, including walking, moderate activity, vigorous activity, and sedentary behavior. The questionnaire applies Metabolic Equivalent of Task (MET) values to estimate weekly energy expenditure and classify participants into low, moderate, or high physical activity levels. The unit of measurement is MET.
From baseline to 8 months
Change from Baseline in Handgrip Strength at 4 and 8 months
Tijdsspanne: From baseline to 8 months
Handgrip strength measured with a dynamometer. Three dominant hand consecutive measurement were taken per participant. The finally considered values per follow-up were the means of those three. The unit of measurement is kg.
From baseline to 8 months
Change from Baseline in Eating Habits at 4 and 8 months
Tijdsspanne: From baseline to 8 months
The Predimed questionnaire is a validated 14-item tool used to assess adherence to the Mediterranean diet, by asking about key dietary habits. Its score oscillates between 0-14 points, with higher values indicating greater adherence.
From baseline to 8 months
Change from Baseline in Nutritional Status at 4 and 8 months
Tijdsspanne: From Baseline to 8 months
The 6-item Mini Nutritional Assessment-Short Form (MNA-SF) was applied to evaluate the nutritional status of patients. The Mini Nutritional Assessment (MNA) is an 18-item validated tool used to evaluate nutritional status in older adults. The unit of measurement is points.
From Baseline to 8 months
Change from Baseline in Blood tests at 4 months
Tijdsspanne: Frome baseline to 4 months
Complete blood count, biochemistry (glucose, urea, creatinine, thyroid hormones, vitamins B12 and D, ions, iron profile), albumin, and C-reactive protein were collected.
Frome baseline to 4 months
Change from Baseline in Cognitive Status at 4 and 8 months
Tijdsspanne: From baseline to 8 months
The Abbreviated Mini-Mental State Examination (MMSE-Short Form) was performed to assess the global cognitive function of the participants. It evaluates orientation, memory, attention, and language in 21 items, and provides a rapid estimate of cognitive status, with lower scores indicating greater impairment.
From baseline to 8 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 december 2024

Primaire voltooiing (Werkelijk)

25 september 2025

Studie voltooiing (Werkelijk)

25 september 2025

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 juni 2026

Eerst geplaatst (Werkelijk)

10 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • GUT-FRG-2024-11

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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