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

Hong Kong Baptist University

Status: Not yet enrolling

Conditions: Frailty in Older Adults

Treatments: Behavioral: Nutritional; Behavioral: Exercise; Behavioral: Psychosocial

Study type: Interventional

Funder types: Other

Identifiers

NCT06741878

12600824

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 308 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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308 participants in 4 patient groups

Exercise Training (Biological) + Board Games (Psychosocial) + Diet Consultation (Nutritional)

Active Comparator group

Treatment:

Behavioral: Psychosocial

Behavioral: Exercise

Behavioral: Nutritional

Exercise Training (Biological) + Diet Consultation (Nutritional)

Active Comparator group

Treatment:

Behavioral: Exercise

Behavioral: Nutritional

Board Games (Psychosocial) + Diet Consultation (Nutritional)

Active Comparator group

Treatment:

Behavioral: Psychosocial

Behavioral: Nutritional

Inactive Control (No Treatment)

No Intervention group