Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program

NCT07848802 | Recruiting

• 1 other identifier: 2026/386
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study will describe changes in physical function and fall risk among adults aged 70 years or older who participate in the routine Frailty and Falls Prevention Program at the Centro Integral de Saúde de Lalín. Clinical assessments obtained before the program (T0) and at its completion (T1, approximately 8-12 weeks later) will be analyzed. The study does not assign treatment or change routine care.

Conditions

Frailty; Fall Risk, Fall Prevention

Keywords

Older Adults; Physical Function; Falls Prevention; Short Physical Performance Battery; Primary Care Physiotherapy; Multicomponent Exercise

Outcome Measures

Primary Outcomes (2)

• Change in Short Physical Performance Battery (SPPB) Total Score

  Change in SPPB total score, a composite measure of lower-extremity function comprising standing balance, gait speed and chair rise. Score range: 0-12 points. Higher scores indicate better physical performance. Unit: points.

  Baseline (T0) and end of the care program (T1, 8-12 weeks).

• Change in Fall Risk Indicators

  Change in the three protocol-defined yes/no indicators: a fall in the preceding year requiring healthcare, two or more falls in the preceding year, and clinically relevant gait impairment. Each indicator is recorded as No or Yes; no composite score or fixed numerical range is specified. A Yes response indicates the corresponding risk feature.

  Baseline (T0) and end of the care program (T1, 8-12 weeks); each assessment uses the protocol-defined recall or clinical assessment.

Secondary Outcomes (12)

• Change in Timed Up and Go Test Time

  Baseline (T0) and end of the care program (T1, 8-12 weeks).

• Change in FRAIL Scale Total Score

  Baseline (T0) and end of the care program (T1, 8-12 weeks).

• Change in Number of Chronic Prescription Medications

  Baseline (T0) and end of the care program (T1, 8-12 weeks).

• Change in 4 Meter Gait Speed

  Baseline (T0) and end of the care program (T1, 8-12 weeks).

• Change in 6 Minute Walk Test Performance

  Baseline (T0) and end of the care program (T1, 8-12 weeks), when the 6-minute walk test is feasible.

Study Arms (1)

Participants in the Lalín Frailty and Falls Prevention Program: adults aged 70 years or older with B

Routine multicomponent therapeutic exercise program; 12 supervised sessions, one per week, with individualized progression. Strength, aerobic, flexibility, balance, functional and dual-task components are described in the care protocol. Home aerobic activity is advised by the treating physiotherapist.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 70 years or older linked to the Centro Integral de Saúde de Lalín who enter its routine Frailty and Falls Prevention Program through usual care and can provide informed consent.

You may not qualify if:

• Medical contraindication to physical activity; inability to consent to study participation.

Sponsors & Collaborators

• University of Vigo: lead
• Servicio Gallego de Salud: collaborator

Study Sites (1)

Centro Integral de Saúde de Lalín

Lalín, Pontevedra, 36500, Spain

RECRUITING

Related Publications (28)

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• Pilotto A, Custodero C, Maggi S, Polidori MC, Veronese N, Ferrucci L. A multidimensional approach to frailty in older people. Ageing Res Rev. 2020 Jul;60:101047. doi: 10.1016/j.arr.2020.101047. Epub 2020 Mar 21.

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• Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019 Oct 12;394(10206):1365-1375. doi: 10.1016/S0140-6736(19)31786-6.

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• Kim KJ, Lee SB, Kim CO. How to Assess Frailty: Role of Comprehensive Geriatric Assessment. J Korean Med Sci. 2020 Jan 20;35(3):e34. doi: 10.3346/jkms.2020.35.e34. No abstract available.

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Related Links

• Description World Health Organization. World report on ageing and health. Geneva: World Health Organization; 2015.
• Description European Commission. The European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) \[Internet\]. Brussels: European Commission
• Description Consejo General de Colegios de Fisioterapia de España. Libro Blanco: Fisioterapia y Fragilidad. 2025
• Description Dirección Xeral de Asistencia Sanitaria. Servizo Galego de Saúde. Carteira de Servizos de Fisioterapia de Atencion Primaria e Comunitaria do Servizo Galego de Saúde. 2023

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lorenzo Antonio Justo Cousiño, PhD

CONTACT

+34 986 801 758; lorenzo.justo@uvigo.gal

Eva Villar Díaz

CONTACT

+34 986 787 093; Eva.Villar.Diaz@sergas.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor's degree in Physiotherapy, PhD in Neuroscience

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 30, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

ES (1)