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)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ángel Moisés Reyes Abreu, Registered Nurse
- 전화번호: +34922474058
- 이메일: enf.enlacetacoronte@gmail.com
연구 연락처 백업
- 이름: Alberto Bermejo Franco, PhD (Physiotherapy)
- 전화번호: +34656932144
- 이메일: alberto.bermejo@universidadeuropea.es
연구 장소
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Santa Cruz de Tenerife
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Tacoronte, Santa Cruz de Tenerife, 스페인, 38350
- 모병
- Centro de Salud Tacoronte
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연락하다:
- Ángel Moisés Reyes Abreu, Registered Nurse
- 전화번호: +34922474058
- 이메일: enf.enlacetacoronte@gmail.com
-
연락하다:
- Alberto Bermejo Franco, PhD (Physiotherapy)
- 전화번호: +34656932144
- 이메일: alberto.bermejo@universidadeuropea.es
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부수사관:
- Carlos Eusebio Esparza Ferrera, Physiotherapist
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참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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활성 비교기: 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.
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Standard primary care management according to regional healthcare guidelines without structured exercise intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in frailty status measured by the FRAIL Scale
기간: Baseline and 12 weeks
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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).
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Baseline and 12 weeks
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Change in physical performance measured by the Short Physical Performance Battery (SPPB)
기간: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Falls
기간: Baseline and 12 weeks
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Number of falls recorded during the study period using participant diaries and verified through electronic medical records.
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Baseline and 12 weeks
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Musculoskeletal Pain Intensity
기간: Baseline and 12 weeks
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Change in perceived musculoskeletal pain measured using a 10-cm Visual Analog Scale (VAS), with higher scores indicating greater pain intensity.
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Baseline and 12 weeks
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Mood and Affective Status
기간: Baseline and 12 weeks
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Change in depressive symptoms measured using the 15-item Geriatric Depression Scale (GDS-15), with higher scores indicating greater depressive symptomatology.
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Baseline and 12 weeks
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Functional Independence
기간: Baseline and 12 weeks
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Change in functional independence measured using the Barthel Index.
Higher scores indicate greater independence in activities of daily living.
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Baseline and 12 weeks
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Nutritional Status
기간: Baseline and 12 weeks
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Change in nutritional status measured using the Mini Nutritional Assessment (MNA), a validated tool for identifying malnutrition and risk of malnutrition in older adults.
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Baseline and 12 weeks
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Handgrip Strength
기간: Baseline and 12 weeks
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Change in upper-limb muscle strength measured by handgrip dynamometry.
The highest value obtained from standardized testing procedures will be recorded.
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Baseline and 12 weeks
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Comorbidity Burden
기간: Baseline and 12 weeks
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Change in clinical comorbidity status assessed using the Charlson Comorbidity Index.
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Baseline and 12 weeks
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Healthcare Resource Utilization
기간: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ángel Moisés Reyes Abreu, Registered Nurse, Centro médico Tacoronte. Adress: Carr. Gral. del Nte., 5, 38350 Tacoronte, Santa Cruz de Tenerife
- 연구 책임자: Alberto Bermejo Franco, PhD (Physiotherapy), Universidad Europea de Madrid. Adress: C/ Tajo, S/N. 28670 Villaviciosa de Odón (Madrid)
간행물 및 유용한 링크
일반 간행물
- Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
- Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
- Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2.
- Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.
- Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
- Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.
- Beard JR, Officer A, de Carvalho IA, Sadana R, Pot AM, Michel JP, Lloyd-Sherlock P, Epping-Jordan JE, Peeters GMEEG, Mahanani WR, Thiyagarajan JA, Chatterji S. The World report on ageing and health: a policy framework for healthy ageing. Lancet. 2016 May 21;387(10033):2145-2154. doi: 10.1016/S0140-6736(15)00516-4. Epub 2015 Oct 29.
- 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.
- Dent E, Martin FC, Bergman H, Woo J, Romero-Ortuno R, Walston JD. Management of frailty: opportunities, challenges, and future directions. Lancet. 2019 Oct 12;394(10206):1376-1386. doi: 10.1016/S0140-6736(19)31785-4.
- Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters DL, Won Won C, Woo J, Vellas B, Fiatarone Singh M. International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. J Nutr Health Aging. 2021;25(7):824-853. doi: 10.1007/s12603-021-1665-8.
- Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Alegre-Tamariz J, Sanchez-Medina J, Runzer-Colmenares FM, Avila-Rodriguez C, Bermejo-Franco A, Parodi JF. Impact of a functional gait training program as a complementary strategy to improve physical function in older adults: a randomized clinical trial. BMC Geriatr. 2025 Oct 21;25(1):789. doi: 10.1186/s12877-025-06471-x.
- Rodriguez-Manas L, Feart C, Mann G, Vina J, Chatterji S, Chodzko-Zajko W, Gonzalez-Colaco Harmand M, Bergman H, Carcaillon L, Nicholson C, Scuteri A, Sinclair A, Pelaez M, Van der Cammen T, Beland F, Bickenbach J, Delamarche P, Ferrucci L, Fried LP, Gutierrez-Robledo LM, Rockwood K, Rodriguez Artalejo F, Serviddio G, Vega E; FOD-CC group (Appendix 1). Searching for an operational definition of frailty: a Delphi method based consensus statement: the frailty operative definition-consensus conference project. J Gerontol A Biol Sci Med Sci. 2013 Jan;68(1):62-7. doi: 10.1093/gerona/gls119. Epub 2012 Apr 16.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHUC_2026_19
- PIFIISC 25/28 (기타 보조금/기금 번호: Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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