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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Change in Physical Performance Short Physical Performance Battery (SPPB) [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]
• Change in Fall Risk [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]
• Change in Instrumented Balance: Center of Pressure (CoP) Sway Area [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]
• Change in Instrumented Balance: Center of Pressure (CoP) Velocity [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]
• Change in Instrumented Balance:Center of Pressure (CoP) Path Length. [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]

Вторичные конечные точки (7)

• Functional Performance: Change in Timed Up and Go (TUG) Test [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]
• Functional Performance: Change in Gait Speed (4-Meter Walk Test) [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]
• Functional Performance: Change in FRAIL Scale Score [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]
• Muscle Strength: Change in Handgrip Strength [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]
• Muscle Strength: Change in 30-Second Sit-to-Stand Test [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]
• Balance [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]
• Aerobic Capacity [Срок оценки: Baseline (T0) and post-intervention (8-12 weeks)]

Критерии участия

Критерии включения

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

Критерии исключения

• Medical contraindication to exercise

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• A Lama — A Lama

Публикации

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• 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. PMID 31233069
• 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. PMID 32365613
• 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. PMID 38828887
• 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 PMID 34409961
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• 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. PMID 38215969
• 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. PMID 39426607

Идентификаторы

NCT: NCT07572851 · 025/447

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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