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NCT Number: NCT07572851

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

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.

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Key information

Conditions

Frail Elderly Fall Risk Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A Lama

A Lama, Pontevedra, 36830, Spain

About this study

Frailty is a clinical condition associated with increased vulnerability to adverse health outcomes, including falls, disability, and mortality. In the Galician public health system, a structured frailty and falls prevention program is implemented within primary care physiotherapy services.

This study is designed as a prospective, longitudinal observational study with pre-post evaluation under real-world clinical conditions, without modifying clinical decision-making or healthcare organization.

Participants aged 70 years and older enrolled in the routine program undergo baseline (T0) and post-intervention (T1) assessments after 8 weeks. The intervention consists of a multicomponent exercise program including strength, balance, and functional training.

The primary objective is to describe changes in physical function and fall risk. Secondary objectives include the characterization of participants, analysis of adherence, recording of adverse events, and evaluation of the feasibility and utility of pressure-platform-based balance assessment.

Additional functional variables (muscle strength, aerobic capacity, and clinical balance tests) are included as part of the standardized functional assessment protocol implemented in routine care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Medical contraindication to exercise

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Physical Performance Short Physical Performance Battery (SPPB)

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    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

  2. Change in Fall Risk

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    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)

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

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    -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

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

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    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

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

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    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

Secondary outcomes

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

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    Time required to stand up, walk 3 meters, turn, return, and sit down.

    • Unit of measure: Seconds
    • Interpretation: Lower values indicate better performance

    The interpretation of TUG results depends on the population (healthy adults, older adults, clinical populations), but general reference thresholds are as follows:

    • Older Adults (Community-Dwelling) < 12 seconds: Normal functional mobility 12-20 seconds: Mild impairment / increased risk of functional decline > 20 seconds: Significant mobility impairment
    • Fall Risk Interpretation > 13.5 seconds: Increased risk of falls (commonly used cut-off)

    Clinical Populations (frail patients) 20-30 seconds: Moderate functional limitation > 30 seconds: Severe dependency in mobility

    A change of approximately ≥ 2-3 seconds is often considered clinically meaningful, depending on the population studied.

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

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    Change in usual walking speed assessed over a 4-meter distance. Gait speed is calculated as distance divided by time and expressed in meters per second (m/s).

    Only gait speed is reported as the outcome measure. Unit of measure: meters per second (m/s). Higher values indicate better functional performance.

    Minimum value: 0 m/s Maximum value: Not applicable (no fixed upper limit; typically < 2.5 m/s in adults) Interpretation: Higher values indicate better functional performance

  3. Functional Performance: Change in FRAIL Scale Score

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    Assessment of frailty status using the FRAIL scale.

    • Score range: 0 to 5
    • Interpretation: Higher scores indicate greater frailty
    • Unit of measure: Points on a scale

  4. Muscle Strength: Change in Handgrip Strength

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    Assessment of maximal isometric grip strength using a dynamometer.

    • Unit of measure: kg (or Newtons, depending on device)
    • Interpretation: Higher values indicate greater strength

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

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    • Unit of measure: Repetitions
    • Interpretation: Higher values indicate better lower limb strength

  6. Balance

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    Unipodal stance or Functional Reach Test

  7. Aerobic Capacity

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    2-Minute Step Test

Other outcomes

  1. Completion Rate of Pressure Platform Assessments

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    Proportion of participants who successfully complete the pressure platform assessment protocol.

    Completion is defined as the participant performing all required trials according to the study protocol.

    Unit of measure: Percentage (%). Higher values indicate better feasibility.

  2. Number of Attempts Required for Successful Assessment

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    Number of attempts needed to obtain valid measurements.

    • Unit of measure: Count

  3. Technical Issues During Assessment

    Time frame: Baseline (T0) and post-intervention (8-12 weeks)

    Number of technical incidents encountered during measurement.

    • Unit of measure: Count

Sponsors and collaborators

Lead sponsor

University of Vigo

Other

Registry information

Official study title

Observational Study of Functional Changes and Fall Risk in Older Adults Participating in a Multicomponent Frailty and Falls Prevention Program in Primary Care

Acronym: FRAIL-ALAMA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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