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

10. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

32

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: Multi-component intervention: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Recruitment rates
Zeitfenster: 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
Zeitfenster: Baseline
The time required to recruit the sample needed for the study was recorded.
Baseline
Participants evaluation time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From baseline to 4 months
Number of attended sessions was registered
From baseline to 4 months
Participant satisfaction
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Pharmacological treatments at 4 months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Biogipuzkoa Health Research Institute

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. Dezember 2024

Primärer Abschluss (Tatsächlich)

25. September 2025

Studienabschluss (Tatsächlich)

25. September 2025

Studienanmeldedaten

Zuerst eingereicht

27. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GUT-FRG-2024-11

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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