A Biopsychosocial Approach to Improving Multidimensional Frailty Status in Community-Dwelling Older Adults

Обзор

Frailty is a common clinical syndrome that is becoming increasingly important as populations age worldwide. Individuals who are frail are at a higher risk for negative outcomes, such as falls, disability, hospitalizations, and even death. The understanding of frailty has evolved from a straightforward concept to a complex model that includes physical, psychological, cognitive, and social factors. Since frailty is not static and can change over time, early interventions can be beneficial. Nevertheless, research in this area has been challenging due to a lack of agreement on what frailty encompasses and an inadequate understanding of how its different components interact. Defining frailty as a multidimensional issue is essential to recognize the adverse effects that can arise from medical, psychological, and social influences. However, recent studies have not sufficiently addressed how these different aspects work together or developed effective multidimensional interventions.

Подробное описание

The study will be designed as a four-arm, double-blinded, cluster-randomised controlled trial. A sample (N = 308) of prefrail older adults aged 60-80 years will be recruited from 32 randomly selected elderly community centres in Hong Kong and classified into four frailty deficit patterns (multi-frailty, physical-to-psycho/social, nonphysical-to-psycho/social, and a robust control). With the hypothesised biopsychosocial framework pinpointing the intertwined relationships of these three domains of frailty, four intervention strategies (biological/psychosocial/nutritional, biological/nutritional, psychosocial/nutritional, and an inactive control) will be proposed to improve their overall frailty, regarding their physical, psychological, and social functioning, nutritional status, and lifestyle changes in a 9-month intervention and follow-up period. The primary objective will be to assess the effectiveness of the intervention strategies for improving the frailty status of participants in each of the four frailty deficit pattern groups, and to determine the most effective intervention strategy.

Вмешательства

• Поведенческое Exercise
  Involves participants engaging in physical training group sessions in light-to-moderate intensity.
• Поведенческое Psychosocial
  Involves participants engaging in selected board and card games which require cognitive and socialization skills to play in a group setting of 2-4 people.
• Поведенческое Nutritional
  Involves participants attending dietary classes taught by a certified dietitian, including individualized consultation.

Первичные конечные точки

• Frailty Status (pre-test) [Срок оценки: Pre-test (1st test): before intervention]
• Frailty Status (2nd test) [Срок оценки: 2nd test: after 3-month intervention]
• Frailty Status (3rd test) [Срок оценки: 3rd test: after 6-month follow up]
• Physical Functioning-- Anthropometic Data (pre-test) [Срок оценки: Pre-test (1st test): before intervention]
• Physical Functioning-- Anthropometric Data (2nd test) [Срок оценки: 2nd test: after 3-month intervention]
• Physical Functioning-- Anthropometric Data (3rd test) [Срок оценки: 3rd test: after 6-month follow up]
• Physical Functioning-- Health Related Information (pre-test) [Срок оценки: Pre-test (1st test): before intervention]
• Physical Functioning-- Health Related Information (2nd test) [Срок оценки: 2nd test: after 3-month intervention]
• Physical Functioning-- Health Related Information (3rd test) [Срок оценки: 3rd test: after 6-month follow up]
• Physical Functioning-- Senior Physical Fitness Test Battery (pre-test) [Срок оценки: Pre-test (1st test): before intervention]

Вторичные конечные точки (12)

• Physical Activity Behavioural Changes (pre-test) [Срок оценки: Pre-test (1st test): before intervention]
• Physical Activity Behavioural Changes (2nd test) [Срок оценки: 2nd test: after 3-month intervention]
• Physical Activity Behavioural Changes (3rd test) [Срок оценки: 3rd test: after 6-month follow up]
• Exercise Self-efficacy (pre-test) [Срок оценки: Pre-test (1st test): before intervention]
• Exercise Self-efficacy (2nd test) [Срок оценки: 2nd test: after 3-month intervention]
• Exercise Self-efficacy (3rd test) [Срок оценки: 3rd test: after 6-month follow up]
• Nutrition Self-efficacy (pre-test) [Срок оценки: Pre-test (1st test): before intervention]
• Nutrition Self-efficacy (2nd test) [Срок оценки: 2nd test: after 3-month intervention]
• Nutrition Self-efficacy (3rd test) [Срок оценки: 3rd test: after 6-month follow up]
• Nutritional Status (pre-test) [Срок оценки: Pre-test (1st test): before intervention]
• Nutritional Status (2nd test) [Срок оценки: 2nd test: after 3-month intervention]
• Nutritional Status (3rd test) [Срок оценки: 3rd test: after 6-month follow up]

Критерии участия

Критерии включения

• Age 60 to 80
• Willing and capable to participate in this study and training
• Willing and capable to give informed consent to participate in this study
• Preliminarily classified as physically prefrail/robust, in that they possess no more than three of the indicators on the Fried Frailty Index (FFI; unintentional weight loss, exhaustion, low physical activity, slow walking speed, weak grip strength; Bieniek et al., 2016)
• Can walk independently to an elderly centre
• Have a smartphone for internal group communication and remote interaction with their peers and the instructor

Критерии исключения

• History of systematic cardiovascular diseases causing stroke, Parkinson's disease, early stages of Alzheimer's disease, or cognitive impairment
• Physical injuries or other conditions that would hinder regular attendance and participation in the assessments for the study
• Concurrent major psychiatric disorder (e.g. major depressive disorder, schizophrenia) or drug and alcohol abuse
• Unable to handle digital devices
• Currently undergoing exercise programmes or classified as physically 'very active' (i.e. performing strenuous activity for 5+ hours each week)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Jiao J, Man DW, Lippke S, Hassel H, Tam BT, Chan CH, Ng YL, Lo KK. A biopsychosocial approach to improving multidimensional frailty status in community-dwelling older adults: a protocol for a cluster randomized controlled trial. BMC Geriatr. 2025 Jul 15;25(1):530. doi: 10.1186/s12877-025-06053-x. PMID 40665217

Идентификаторы

NCT: NCT06741878 · 12600824

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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