Functional Changes and Fall Risk in Older Adults Participating in a Frailty Program (FRAIL-ALAMA)
Observational Study of Functional Changes and Fall Risk in Older Adults Participating in a Multicomponent Frailty and Falls Prevention Program in Primary Care
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Pontevedra
-
A Lama, Pontevedra, España, 36830
- A Lama
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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.
Descripción
Inclusion Criteria:
- Age ≥70 years
- Barthel Index ≥90
- Participation in the frailty program
- Ability to provide informed consent
Exclusion Criteria:
- Medical contraindication to exercise
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
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
|
Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 2 times per week.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Physical Performance Short Physical Performance Battery (SPPB)
Periodo de tiempo: 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.
|
Baseline (T0) and post-intervention (8-12 weeks)
|
|
Change in Fall Risk
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional Performance: Change in Timed Up and Go (TUG) Test
Periodo de tiempo: Baseline (T0) and post-intervention (8-12 weeks)
|
Time required to stand up, walk 3 meters, turn, return, and sit down.
The interpretation of TUG results depends on the population (healthy adults, older adults, clinical populations), but general reference thresholds are as follows:
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)
Periodo de tiempo: 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
Periodo de tiempo: Baseline (T0) and post-intervention (8-12 weeks)
|
Assessment of frailty status using the FRAIL scale.
|
Baseline (T0) and post-intervention (8-12 weeks)
|
|
Muscle Strength: Change in Handgrip Strength
Periodo de tiempo: Baseline (T0) and post-intervention (8-12 weeks)
|
Assessment of maximal isometric grip strength using a dynamometer.
|
Baseline (T0) and post-intervention (8-12 weeks)
|
|
Muscle Strength: Change in 30-Second Sit-to-Stand Test
Periodo de tiempo: Baseline (T0) and post-intervention (8-12 weeks)
|
|
Baseline (T0) and post-intervention (8-12 weeks)
|
|
Balance
Periodo de tiempo: Baseline (T0) and post-intervention (8-12 weeks)
|
Unipodal stance or Functional Reach Test
|
Baseline (T0) and post-intervention (8-12 weeks)
|
|
Aerobic Capacity
Periodo de tiempo: Baseline (T0) and post-intervention (8-12 weeks)
|
2-Minute Step Test
|
Baseline (T0) and post-intervention (8-12 weeks)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Completion Rate of Pressure Platform Assessments
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lorenzo Justo-Cousiño, PhD, Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Pontevedra, Spain
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006 May;54(5):743-9. doi: 10.1111/j.1532-5415.2006.00701.x.
- Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
- 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.
- 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.
- Angulo J, El Assar M, Alvarez-Bustos A, Rodriguez-Manas L. Physical activity and exercise: Strategies to manage frailty. Redox Biol. 2020 Aug;35:101513. doi: 10.1016/j.redox.2020.101513. Epub 2020 Mar 20.
- Lee H, Lee E, Jang IY. Frailty and Comprehensive Geriatric Assessment. J Korean Med Sci. 2020 Jan 20;35(3):e16. doi: 10.3346/jkms.2020.35.e16.
- Beckwee D, Delaere A, Aelbrecht S, Baert V, Beaudart C, Bruyere O, de Saint-Hubert M, Bautmans I. Exercise Interventions for the Prevention and Treatment of Sarcopenia. A Systematic Umbrella Review. J Nutr Health Aging. 2019;23(6):494-502. doi: 10.1007/s12603-019-1196-8.
- 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.
- Chittrakul J, Siviroj P, Sungkarat S, Sapbamrer R. Multi-System Physical Exercise Intervention for Fall Prevention and Quality of Life in Pre-Frail Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Apr 29;17(9):3102. doi: 10.3390/ijerph17093102.
- Choi JY, Park JW, Kim KI, Lee YK, Kim CH. Prediction of 5-Year Survival Rate After Hip Fracture Surgery Using a Comprehensive Geriatric Assessment-Based Frailty Score Model. J Korean Med Sci. 2025 Mar 31;40(12):e40. doi: 10.3346/jkms.2025.40.e40.
- Sato R, Vatic M, Peixoto da Fonseca GW, Anker SD, von Haehling S. Biological basis and treatment of frailty and sarcopenia. Cardiovasc Res. 2024 Jul 31;120(9):982-998. doi: 10.1093/cvr/cvae073.
- Allison R 2nd, Assadzandi S, Adelman M. Frailty: Evaluation and Management. Am Fam Physician. 2021 Feb 15;103(4):219-226.
- Vazquez-Guajardo M, Rivas D, Duque G. Exercise as a Therapeutic Tool in Age-Related Frailty and Cardiovascular Disease: Challenges and Strategies. Can J Cardiol. 2024 Aug;40(8):1458-1467. doi: 10.1016/j.cjca.2024.01.005. Epub 2024 Jan 10.
- Yang X, Li S, Xu L, Liu H, Li Y, Song X, Bao J, Liao S, Xi Y, Guo G. Effects of multicomponent exercise on frailty status and physical function in frail older adults: A meta-analysis and systematic review. Exp Gerontol. 2024 Nov;197:112604. doi: 10.1016/j.exger.2024.112604. Epub 2024 Oct 21.
- Sadjapong U, Yodkeeree S, Sungkarat S, Siviroj P. Multicomponent Exercise Program Reduces Frailty and Inflammatory Biomarkers and Improves Physical Performance in Community-Dwelling Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 May 26;17(11):3760. doi: 10.3390/ijerph17113760.
- Dent E, Daly RM, Hoogendijk EO, Scott D. Exercise to Prevent and Manage Frailty and Fragility Fractures. Curr Osteoporos Rep. 2023 Apr;21(2):205-215. doi: 10.1007/s11914-023-00777-8. Epub 2023 Mar 28.
- Lee JE, Chun H, Kim YS, Jung HW, Jang IY, Cha HM, Son KY, Cho B, Kwon IS, Yoon JL. Association between Timed Up and Go Test and Subsequent Functional Dependency. J Korean Med Sci. 2020 Jan 20;35(3):e25. doi: 10.3346/jkms.2020.35.e25.
- 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.
- Deng Y, Zhang K, Zhu J, Hu X, Liao R. Healthy aging, early screening, and interventions for frailty in the elderly. Biosci Trends. 2023 Sep 15;17(4):252-261. doi: 10.5582/bst.2023.01204. Epub 2023 Aug 23.
- Proietti M, Cesari M. Frailty: What Is It? Adv Exp Med Biol. 2020;1216:1-7. doi: 10.1007/978-3-030-33330-0_1.
- 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.
- Brar S, Hopkins M, Margolius D. Time to Next Available Appointment as an Access to Care Metric. Jt Comm J Qual Patient Saf. 2019 Nov;45(11):779-780. doi: 10.1016/j.jcjq.2019.07.007. Epub 2019 Aug 29. No abstract available.
Enlaces Útiles
- 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 025/447
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .