Functional Changes and Fall Risk in Older Adults Participating in a Frailty Program

NCT07572851 | Enrolling By Invitation

• 1 other identifier: 025/447
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to describe changes in physical function and fall risk in adults aged 70 years and older participating in a routine multicomponent frailty and falls prevention program in primary care. Participants are evaluated before and after the intervention, and additional postural control variables are recorded using a pressure platform without modifying routine clinical care.

Conditions

Frail Elderly; Fall Risk

Keywords

Frailty; Falls prevention; Older adults; Physical function; SPPB; Sit-to-Stand; Primary care physiotherapy

Outcome Measures

Primary Outcomes (5)

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

  Change in Short Physical Performance Battery (SPPB) total score. The SPPB is a composite measure of lower extremity function including balance, gait speed, and chair stand tests. * Score range: 0 to 12 * Interpretation: Higher scores indicate better physical performance * Unit of measure: Points on a scale

  Baseline (T0) and post-intervention (8-12 weeks)

• Change in Fall Risk

  Change in fall risk indicators based on clinical assessment (falls history and gait impairment). Minimum value: 0 Maximum value: Not applicable (composite clinical indicator; upper bound not fixed) Interpretation: Higher values indicate worse outcome (greater fall risk)

  Baseline (T0) and post-intervention (8-12 weeks)

• Change in Instrumented Balance: Center of Pressure (CoP) Sway Area

  -Change in Center of Pressure (CoP) Sway Area Change in postural sway area measured using a pressure platform. The Center of Pressure (CoP) sway area represents the area covered by the CoP trajectory during quiet standing. Unit of measure: square millimeters (mm²). Higher values indicate worse postural stability. Minimum value: 0 mm² Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability

  Baseline (T0) and post-intervention (8-12 weeks)

• Change in Instrumented Balance: Center of Pressure (CoP) Velocity

  Change in Center of Pressure (CoP) Velocity Change in mean velocity of center of pressure displacement. • Unit of measure: mm/s Minimum value: 0 mm/s Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability

  Baseline (T0) and post-intervention (8-12 weeks)

• Change in Instrumented Balance:Center of Pressure (CoP) Path Length.

  Change in Center of Pressure (CoP) Path Length Change in total trajectory length of center of pressure. • Unit of measure: mm Minimum value: 0 mm Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability

  Baseline (T0) and post-intervention (8-12 weeks)

Secondary Outcomes (7)

• Functional Performance: Change in Timed Up and Go (TUG) Test

  Baseline (T0) and post-intervention (8-12 weeks)

• Functional Performance: Change in Gait Speed (4-Meter Walk Test)

  Baseline (T0) and post-intervention (8-12 weeks)

• Functional Performance: Change in FRAIL Scale Score

  Baseline (T0) and post-intervention (8-12 weeks)

• Muscle Strength: Change in Handgrip Strength

  Baseline (T0) and post-intervention (8-12 weeks)

• Muscle Strength: Change in 30-Second Sit-to-Stand Test

  Baseline (T0) and post-intervention (8-12 weeks)

Other Outcomes (3)

• Completion Rate of Pressure Platform Assessments

  Baseline (T0) and post-intervention (8-12 weeks)

• Number of Attempts Required for Successful Assessment

  Baseline (T0) and post-intervention (8-12 weeks)

• Technical Issues During Assessment

  Baseline (T0) and post-intervention (8-12 weeks)

Study Arms (2)

Frailty Program Participants- 1 day/week exercise program

Adults aged ≥70 years with preserved basic functional independence (Barthel Index ≥90) participating in a routine multicomponent exercise program for frailty and fall prevention in primary care. The participants of this group will attend one multicomponent exercise session per week

Other: Multicomponent Exercise Program- 1 times per week.

Frailty Program Participants- 2 day/week exercise program

Adults aged ≥70 years with preserved basic functional independence (Barthel Index ≥90) participating in a routine multicomponent exercise program for frailty and fall prevention in primary care. The participants of this group will attend two multicomponent exercise session per week

Other: Multicomponent Exercise Program- 2 times per week.

Interventions

Multicomponent Exercise Program- 1 times per week. OTHER

Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 1 times per week.

Frailty Program Participants- 1 day/week exercise program

Multicomponent Exercise Program- 2 times per week. OTHER

Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 2 times per week.

Frailty Program Participants- 2 day/week exercise program

Eligibility Criteria

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

Study Population

The study population consists of older adults aged 70 years and above who are currently enrolled in the frailty prevention program within the Galician public health system. These individuals have been identified as frail or pre-frail through routine primary care screening and demonstrate sufficient functional capacity, as indicated by a Barthel Index score of 90 or higher, reflecting independence in basic activities of daily living. Eligible participants must be able to understand the study procedures and provide informed consent, ensuring that they can engage safely and meaningfully in the intervention. All participants are actively involved in the structured frailty program delivered by primary care physiotherapy services, which focuses on preventing functional decline and reducing the risk of falls. Individuals will be excluded if they present with any medical contraindication to exercise.

You may qualify if:

• Age ≥70 years
• Barthel Index ≥90
• Participation in the frailty program
• Ability to provide informed consent

You may not qualify if:

• Medical contraindication to exercise

Sponsors & Collaborators

• University of Vigo: lead

Study Sites (1)

A Lama

A Lama, Pontevedra, 36830, Spain

Location

Related Publications (23)

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Related Links

• World Health Organization. World report on ageing and health. Geneva: World Health Organization; 2015.
• European Commission. The European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) \[Internet\]. Brussels: European Commission
• Consejo General de Colegios de Fisioterapia de España. Libro Blanco: Fisioterapia y Fragilidad. 2025
• 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

Study Officials

• Lorenzo Justo-Cousiño, PhD

  Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Pontevedra, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physical therapist

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: May 7, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

ES (1)