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

June 7, 2026 updated by: Alberto Bermejo Franco, Universidad Europea de Madrid

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

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 Contact

Study Contact Backup

Study Locations

  • Spain
    • Santa Cruz de Tenerife
      • Tacoronte, Santa Cruz de Tenerife, Spain, 38350
        • Recruiting
        • Centro de Salud Tacoronte
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Carlos Eusebio Esparza Ferrera, Physiotherapist

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:

  • 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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
Other: Usual Care
Standard primary care management according to regional healthcare guidelines without structured exercise intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in frailty status measured by the FRAIL Scale
Time Frame: Baseline and 12 weeks
Change in FRAIL Scale score from baseline to the end of the 12-week intervention. The FRAIL Scale classifies participants as robust (0), pre-frail (1-2), or frail (3-5).
Baseline and 12 weeks
Change in physical performance measured by the Short Physical Performance Battery (SPPB)
Time Frame: Baseline and 12 weeks
Change in SPPB score from baseline to the end of the 12-week intervention. The SPPB evaluates balance, gait speed, and lower-extremity strength, with higher scores indicating better physical performance.
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Falls
Time Frame: 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
Musculoskeletal Pain Intensity
Time Frame: Baseline and 12 weeks
Change in perceived musculoskeletal pain measured using a 10-cm Visual Analog Scale (VAS), with higher scores indicating greater pain intensity.
Baseline and 12 weeks
Mood and Affective Status
Time Frame: Baseline and 12 weeks
Change in depressive symptoms measured using the 15-item Geriatric Depression Scale (GDS-15), with higher scores indicating greater depressive symptomatology.
Baseline and 12 weeks
Functional Independence
Time Frame: Baseline and 12 weeks
Change in functional independence measured using the Barthel Index. Higher scores indicate greater independence in activities of daily living.
Baseline and 12 weeks
Nutritional Status
Time Frame: Baseline and 12 weeks
Change in nutritional status measured using the Mini Nutritional Assessment (MNA), a validated tool for identifying malnutrition and risk of malnutrition in older adults.
Baseline and 12 weeks
Handgrip Strength
Time Frame: 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
Time Frame: Baseline and 12 weeks
Change in clinical comorbidity status assessed using the Charlson Comorbidity Index.
Baseline and 12 weeks
Healthcare Resource Utilization
Time Frame: 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

Collaborators and Investigators

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

Sponsor

Universidad Europea de Madrid

Investigators

  • Principal Investigator: Ángel Moisés Reyes Abreu, Registered Nurse, Centro médico Tacoronte. Adress: Carr. Gral. del Nte., 5, 38350 Tacoronte, Santa Cruz de Tenerife
  • Study Director: Alberto Bermejo Franco, PhD (Physiotherapy), Universidad Europea de Madrid. Adress: C/ Tajo, S/N. 28670 Villaviciosa de Odón (Madrid)

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

Helpful Links

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)

May 28, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 7, 2026

First Submitted That Met QC Criteria

June 7, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 7, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUC_2026_19
  • PIFIISC 25/28 (Other Grant/Funding Number: Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

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.

Clinical Trials on Frail Elderly

Clinical Trials on FRAIL+AP Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe