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

June 10, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rates
Time Frame: 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
Time Frame: Baseline
The time required to recruit the sample needed for the study was recorded.
Baseline
Participants evaluation time
Time Frame: 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
Time Frame: 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
Time Frame: From baseline to 4 months
Number of attended sessions was registered
From baseline to 4 months
Participant satisfaction
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Pharmacological treatments at 4 months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogipuzkoa Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2024

Primary Completion (Actual)

September 25, 2025

Study Completion (Actual)

September 25, 2025

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUT-FRG-2024-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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