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Functional Changes and Fall Risk in Older Adults Participating in a Frailty Program (FRAIL-ALAMA)

2026년 4월 30일 업데이트: Lorenzo Antonio Justo Cousino, PhD, University of Vigo

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

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.

연구 개요

상태

초대로 등록

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

56

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 스페인
    • Pontevedra
      • A Lama, Pontevedra, 스페인, 36830
        • A Lama

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

Inclusion Criteria:

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

Exclusion Criteria:

  • Medical contraindication to exercise

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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
다른: Multicomponent Exercise Program- 1 times per week.
Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 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
다른: Multicomponent Exercise Program- 2 times per week.
Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 2 times per week.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Physical Performance Short Physical Performance Battery (SPPB)
기간: 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
Baseline (T0) and post-intervention (8-12 weeks)
Change in Fall Risk
기간: 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)
Baseline (T0) and post-intervention (8-12 weeks)
Change in Instrumented Balance: Center of Pressure (CoP) Sway Area
기간: 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
Baseline (T0) and post-intervention (8-12 weeks)
Change in Instrumented Balance: Center of Pressure (CoP) Velocity
기간: 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
Baseline (T0) and post-intervention (8-12 weeks)
Change in Instrumented Balance:Center of Pressure (CoP) Path Length.
기간: 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
Baseline (T0) and post-intervention (8-12 weeks)

2차 결과 측정

결과 측정
측정값 설명
기간
Functional Performance: Change in Timed Up and Go (TUG) Test
기간: 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.
Baseline (T0) and post-intervention (8-12 weeks)
Functional Performance: Change in Gait Speed (4-Meter Walk Test)
기간: 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
Baseline (T0) and post-intervention (8-12 weeks)
Functional Performance: Change in FRAIL Scale Score
기간: 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
Baseline (T0) and post-intervention (8-12 weeks)
Muscle Strength: Change in Handgrip Strength
기간: 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
Baseline (T0) and post-intervention (8-12 weeks)
Muscle Strength: Change in 30-Second Sit-to-Stand Test
기간: Baseline (T0) and post-intervention (8-12 weeks)
  • Unit of measure: Repetitions
  • Interpretation: Higher values indicate better lower limb strength
Baseline (T0) and post-intervention (8-12 weeks)
Balance
기간: Baseline (T0) and post-intervention (8-12 weeks)
Unipodal stance or Functional Reach Test
Baseline (T0) and post-intervention (8-12 weeks)
Aerobic Capacity
기간: Baseline (T0) and post-intervention (8-12 weeks)
2-Minute Step Test
Baseline (T0) and post-intervention (8-12 weeks)

기타 결과 측정

결과 측정
측정값 설명
기간
Completion Rate of Pressure Platform Assessments
기간: 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.
Baseline (T0) and post-intervention (8-12 weeks)
Number of Attempts Required for Successful Assessment
기간: Baseline (T0) and post-intervention (8-12 weeks)

Number of attempts needed to obtain valid measurements.

• Unit of measure: Count
Baseline (T0) and post-intervention (8-12 weeks)
Technical Issues During Assessment
기간: Baseline (T0) and post-intervention (8-12 weeks)

Number of technical incidents encountered during measurement.

• Unit of measure: Count
Baseline (T0) and post-intervention (8-12 weeks)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Vigo

수사관

  • 수석 연구원: Lorenzo Justo-Cousiño, PhD, Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Pontevedra, Spain

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 2일

기본 완료 (추정된)

2026년 6월 1일

연구 완료 (추정된)

2026년 7월 30일

연구 등록 날짜

최초 제출

2026년 4월 2일

QC 기준을 충족하는 최초 제출

2026년 4월 30일

처음 게시됨 (실제)

2026년 5월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 30일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 025/447

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Protocol states data will not be shared with third parties

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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