Clinical trial NCT06741878: A Biopsychosocial Approach to Improving Multidimensional Frailty Status in Community-Dwelling Older Adults
Official title: A Biopsychosocial Approach to Improving Multidimensional Frailty Status in Community-Dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty in Older Adults
Keywords: Multi-dimensional frailty
Biopsychosocial approach
Exercise training
Nutrition education
Psychosocial support
Older adults
Intervention programs
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Coburg University of Applied Sciences and Arts
name: The Hong Kong Polytechnic University
name: Tung Wah College
name: Research Grants Council, Hong Kong
name: Constructor University
First posted: 2024-12-19
Enrollment: 308
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Frailty Status (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Frailty Status (2nd test)
timeFrame: 2nd test: after 3-month intervention
measure: Frailty Status (3rd test)
timeFrame: 3rd test: after 6-month follow up
measure: Physical Functioning-- Anthropometic Data (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Physical Functioning-- Anthropometric Data (2nd test)
timeFrame: 2nd test: after 3-month intervention
measure: Physical Functioning-- Anthropometric Data (3rd test)
timeFrame: 3rd test: after 6-month follow up
measure: Physical Functioning-- Health Related Information (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Physical Functioning-- Health Related Information (2nd test)
timeFrame: 2nd test: after 3-month intervention
measure: Physical Functioning-- Health Related Information (3rd test)
timeFrame: 3rd test: after 6-month follow up
measure: Physical Functioning-- Senior Physical Fitness Test Battery (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Physical Functioning-- Senior Physical Fitness Test Battery (2nd test)
timeFrame: 2nd test: after 3-month intervention
measure: Physical Functioning-- Senior Physical Fitness Test Battery (3rd test)
timeFrame: 3rd test: after 6-month follow up
measure: Psychological Functioning (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Psychological Functioning (2nd test)
timeFrame: 2nd test: after 3-month intervention
measure: Psychological Functioning (3rd test)
timeFrame: 3rd test: after 6-month follow up
measure: Social Function (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Social Function (2nd test)
timeFrame: 2nd test: after 3-month intervention
measure: Social Function (3rd test)
timeFrame: 3rd test: after 6-month follow up
Secondary outcomes:
measure: Physical Activity Behavioural Changes (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Physical Activity Behavioural Changes (2nd test)
timeFrame: 2nd test: after 3-month intervention
measure: Physical Activity Behavioural Changes (3rd test)
timeFrame: 3rd test: after 6-month follow up
measure: Exercise Self-efficacy (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Exercise Self-efficacy (2nd test)
timeFrame: 2nd test: after 3-month intervention
measure: Exercise Self-efficacy (3rd test)
timeFrame: 3rd test: after 6-month follow up
measure: Nutrition Self-efficacy (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Nutrition Self-efficacy (2nd test)
timeFrame: 2nd test: after 3-month intervention
measure: Nutrition Self-efficacy (3rd test)
timeFrame: 3rd test: after 6-month follow up
measure: Nutritional Status (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Nutritional Status (2nd test)
timeFrame: 2nd test: after 3-month intervention
measure: Nutritional Status (3rd test)
timeFrame: 3rd test: after 6-month follow up
Other outcomes:
Locations:
Study officials:
References: