Designing a Multicomponent Intervention for Improving Frailty. A Pilot Study in the Basque Country
10 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
32
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Gipuzkoa
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San Sebastián, Gipuzkoa, Spagna, 20014
- Biogipuzkoa Health Research Institute. Primary Care Group. Epidemiology, Public Health and Primary Care Area.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Recruitment rates
Lasso di tempo: Baseline
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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.
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Baseline
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Time required to recruit the sample
Lasso di tempo: Baseline
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The time required to recruit the sample needed for the study was recorded.
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Baseline
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Participants evaluation time
Lasso di tempo: From baseline to 8 months
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The professionals recorded the evaluation time each participant required
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From baseline to 8 months
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Professionals' opinion on the difficulty and adequacy of the process
Lasso di tempo: From baseline to 8 months
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Professionals who performed the baseline and follow-up assessments completed a questionnaire on the difficulty and adequacy of the process
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From baseline to 8 months
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Adherence to the intervention
Lasso di tempo: From baseline to 4 months
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Number of attended sessions was registered
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From baseline to 4 months
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Participant satisfaction
Lasso di tempo: Month 4
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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.
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Month 4
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from Baseline in Pharmacological treatments at 4 months
Lasso di tempo: From Baseline to 4 months
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Change in the number of pharmacological treatments.
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From Baseline to 4 months
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Change from Baseline in the Health-related quality of life at 4 and 8 months
Lasso di tempo: From baseline to 8 months
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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.
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From baseline to 8 months
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Change from Baseline in Anxiety and Depression Status at 4 and 8 months
Lasso di tempo: From baseline to 8 months
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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.
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From baseline to 8 months
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Change from Baseline in Dependence at 4 and 8 months
Lasso di tempo: From Baseline to 8 months
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Lawton instrumental activities of daily living based on 8 items, with higher values indicating more independence.
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From Baseline to 8 months
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Change from Baseline in Social Connectedness at 4 and 8 months
Lasso di tempo: From baseline to 8 months
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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.
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From baseline to 8 months
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Change from Baseline in Functional Capacity at 4 and 8 months
Lasso di tempo: From baseline to 8 months
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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.
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From baseline to 8 months
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Change from Baseline in Physical Activity at 4 and 8 months
Lasso di tempo: From baseline to 8 months
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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.
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From baseline to 8 months
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Change from Baseline in Handgrip Strength at 4 and 8 months
Lasso di tempo: From baseline to 8 months
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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.
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From baseline to 8 months
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Change from Baseline in Eating Habits at 4 and 8 months
Lasso di tempo: From baseline to 8 months
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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.
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From baseline to 8 months
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Change from Baseline in Nutritional Status at 4 and 8 months
Lasso di tempo: From Baseline to 8 months
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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.
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From Baseline to 8 months
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Change from Baseline in Blood tests at 4 months
Lasso di tempo: Frome baseline to 4 months
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Complete blood count, biochemistry (glucose, urea, creatinine, thyroid hormones, vitamins B12 and D, ions, iron profile), albumin, and C-reactive protein were collected.
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Frome baseline to 4 months
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Change from Baseline in Cognitive Status at 4 and 8 months
Lasso di tempo: From baseline to 8 months
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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.
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From baseline to 8 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Gutierrez-Valencia M, Izquierdo M, Cesari M, Casas-Herrero A, Inzitari M, Martinez-Velilla N. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-1444. doi: 10.1111/bcp.13590. Epub 2018 May 3.
- O'Caoimh R, Sezgin D, O'Donovan MR, Molloy DW, Clegg A, Rockwood K, Liew A. Prevalence of frailty in 62 countries across the world: a systematic review and meta-analysis of population-level studies. Age Ageing. 2021 Jan 8;50(1):96-104. doi: 10.1093/ageing/afaa219.
- Rivas-Ruiz F, Machon M, Contreras-Fernandez E, Vrotsou K, Padilla-Ruiz M, Diez Ruiz AI, de Mesa Berenguer Y, Vergara I; Group GIFEA. Prevalence of frailty among community-dwelling elderly persons in Spain and factors associated with it. Eur J Gen Pract. 2019 Oct;25(4):190-196. doi: 10.1080/13814788.2019.1635113. Epub 2019 Oct 22.
- Yang X, Li S, Xu L, Liu H, Li Y, Song X, Bao J, Liao S, Xi Y, Guo G. Effects of multicomponent exercise on frailty status and physical function in frail older adults: A meta-analysis and systematic review. Exp Gerontol. 2024 Nov;197:112604. doi: 10.1016/j.exger.2024.112604. Epub 2024 Oct 21.
- Tao A, Ho KHM, Yang C, Chan HYL. Effects of non-pharmacological interventions on psychological outcomes among older people with frailty: A systematic review and meta-analysis. Int J Nurs Stud. 2023 Apr;140:104437. doi: 10.1016/j.ijnurstu.2023.104437. Epub 2023 Jan 14.
- Sirikul W, Buawangpong N, Pinyopornpanish K, Siviroj P. Impact of multicomponent exercise and nutritional supplement interventions for improving physical frailty in community-dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2024 Nov 18;24(1):958. doi: 10.1186/s12877-024-05551-8.
- Morin KH. Clarifying the Importance of Pilot Studies. J Nurs Educ. 2023 Sep;62(9):487-488. doi: 10.3928/01484834-20230712-03. Epub 2023 Sep 1. No abstract available.
- Rashidi Pour Fard N, Amirabdollahian F, Haghighatdoost F. Dietary patterns and frailty: a systematic review and meta-analysis. Nutr Rev. 2019 Jul 1;77(7):498-513. doi: 10.1093/nutrit/nuz007.
- Nan J, Duan Y, Wu S, Liao L, Li X, Zhao Y, Zhang H, Zeng X, Feng H. Perspectives of older adults, caregivers, healthcare providers on frailty screening in primary care: a systematic review and qualitative meta-synthesis. BMC Geriatr. 2022 Jun 3;22(1):482. doi: 10.1186/s12877-022-03173-6.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
23 dicembre 2024
Completamento primario (Effettivo)
25 settembre 2025
Completamento dello studio (Effettivo)
25 settembre 2025
Date di iscrizione allo studio
Primo inviato
27 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
4 giugno 2026
Primo Inserito (Effettivo)
10 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GUT-FRG-2024-11
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .