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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty in Older Adults
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Psychosocial; Behavioral: Nutritional

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.

• Study Type: Interventional
• Enrollment (Estimated): 308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiao JIAO, PhD; Phone Number: (852)34117005; Email: jojojiao@hkbu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise Training (Biological) + Board Games (Psychosocial) + Diet Consultation (Nutritional)	Behavioral: Exercise; Involves participants engaging in physical training group sessions in light-to-moderate intensity.; Behavioral: 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.; Behavioral: Nutritional; Involves participants attending dietary classes taught by a certified dietitian, including individualized consultation.
Active Comparator: Exercise Training (Biological) + Diet Consultation (Nutritional)	Behavioral: Exercise; Involves participants engaging in physical training group sessions in light-to-moderate intensity.; Behavioral: Nutritional; Involves participants attending dietary classes taught by a certified dietitian, including individualized consultation.
Active Comparator: Board Games (Psychosocial) + Diet Consultation (Nutritional)	Behavioral: 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.; Behavioral: Nutritional; Involves participants attending dietary classes taught by a certified dietitian, including individualized consultation.
No Intervention: Inactive Control (No Treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty Status (pre-test)	The Tilburg Frailty Indicator (TFI), with three subdomains (physical, psychological, and social), will be used in three evaluation time frames, respectively. The total TFI score ranges from 0 to 15, with a score of 5 (or above) indicating frailty.	Pre-test (1st test): before intervention
Frailty Status (2nd test)	The Tilburg Frailty Indicator (TFI), with three subdomains (physical, psychological, and social), will be used in three evaluation time frames, respectively. The total TFI score ranges from 0 to 15, with a score of 5 (or above) indicating frailty.	2nd test: after 3-month intervention
Frailty Status (3rd test)	The Tilburg Frailty Indicator (TFI), with three subdomains (physical, psychological, and social), will be used in three evaluation time frames, respectively. The total TFI score ranges from 0 to 15, with a score of 5 (or above) indicating frailty.	3rd test: after 6-month follow up
Physical Functioning-- Anthropometic Data (pre-test)	Anthropometric data (e.g. BMI in kg/m^2) will be evaluated in 3 time frames, respectively.	Pre-test (1st test): before intervention
Physical Functioning-- Anthropometric Data (2nd test)	Anthropometric data (e.g. BMI in kg/m^2) will be evaluated in 3 time frames, respectively.	2nd test: after 3-month intervention
Physical Functioning-- Anthropometric Data (3rd test)	Anthropometric data (e.g. BMI in kg/m^2) will be evaluated in 3 time frames, respectively.	3rd test: after 6-month follow up
Physical Functioning-- Health Related Information (pre-test)	Health-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.	Pre-test (1st test): before intervention
Physical Functioning-- Health Related Information (2nd test)	Health-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.	2nd test: after 3-month intervention
Physical Functioning-- Health Related Information (3rd test)	Health-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.	3rd test: after 6-month follow up
Physical Functioning-- Senior Physical Fitness Test Battery (pre-test)	The senior physical fitness test battery (SPFT) (Jones, 2013) will be used in three evaluation time frames, respectively. The SPFT consists of six physical tests for assessing functional fitness in the elderly: 30 sec arm curl (muscular strength), 30 sec chair stand (muscular strength), 2 min step test (aerobic endurance), chair sit-and-reach (flexibility), back scratch test (flexibility), and up-and-go (dynamic balance).	Pre-test (1st test): before intervention
Physical Functioning-- Senior Physical Fitness Test Battery (2nd test)	The senior physical fitness test battery (SPFT) (Jones, 2013) will be used in three evaluation time frames, respectively. The SPFT consists of six physical tests for assessing functional fitness in the elderly: 30 sec arm curl (muscular strength), 30 sec chair stand (muscular strength), 2 min step test (aerobic endurance), chair sit-and-reach (flexibility), back scratch test (flexibility), and up-and-go (dynamic balance).	2nd test: after 3-month intervention
Physical Functioning-- Senior Physical Fitness Test Battery (3rd test)	The senior physical fitness test battery (SPFT) (Jones, 2013) will be used in three evaluation time frames, respectively. The SPFT consists of six physical tests for assessing functional fitness in the elderly: 30 sec arm curl (muscular strength), 30 sec chair stand (muscular strength), 2 min step test (aerobic endurance), chair sit-and-reach (flexibility), back scratch test (flexibility), and up-and-go (dynamic balance).	3rd test: after 6-month follow up
Psychological Functioning (pre-test)	A seven-item scale of psychological well-being, which is an indicator of psychological functioning in the Comprehensive Model of Frailty (CMF) (Kwan et al., 2015), will be used in three evaluation time frames, respectively.	Pre-test (1st test): before intervention
Psychological Functioning (2nd test)	A seven-item scale of psychological well-being, which is an indicator of psychological functioning in the Comprehensive Model of Frailty (CMF) (Kwan et al., 2015), will be used in three evaluation time frames, respectively.	2nd test: after 3-month intervention
Psychological Functioning (3rd test)	A seven-item scale of psychological well-being, which is an indicator of psychological functioning in the Comprehensive Model of Frailty (CMF) (Kwan et al., 2015), will be used in three evaluation time frames, respectively.	3rd test: after 6-month follow up
Social Function (pre-test)	The risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.	Pre-test (1st test): before intervention
Social Function (2nd test)	The risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.	2nd test: after 3-month intervention
Social Function (3rd test)	The risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.	3rd test: after 6-month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Behavioural Changes (pre-test)	Scales of physical activity behavioural change, intention/motivation, loneliness, subjective physical health, and health status will be measured using a survey that was used in a previous project (Chow et al., 2022), in three time frames.	Pre-test (1st test): before intervention
Physical Activity Behavioural Changes (2nd test)	Scales of physical activity behavioural change, intention/motivation, loneliness, subjective physical health, and health status will be measured using a survey that was used in a previous project (Chow et al., 2022), in three time frames.	2nd test: after 3-month intervention
Physical Activity Behavioural Changes (3rd test)	Scales of physical activity behavioural change, intention/motivation, loneliness, subjective physical health, and health status will be measured using a survey that was used in a previous project (Chow et al., 2022), in three time frames.	3rd test: after 6-month follow up
Exercise Self-efficacy (pre-test)	Assessed using the validated Chinese scales of the Physical Exercise Self-efficacy Scale (PESES), a 5-item instrument with a 4-point Likert-type scale, ranging from 5 to 20. Higher scores shows higher routine physical exercise self-efficacy.	Pre-test (1st test): before intervention
Exercise Self-efficacy (2nd test)	Assessed using the validated Chinese scales of the Physical Exercise Self-efficacy Scale (PESES), a 5-item instrument with a 4-point Likert-type scale, ranging from 5 to 20. Higher scores shows higher routine physical exercise self-efficacy.	2nd test: after 3-month intervention
Exercise Self-efficacy (3rd test)	Assessed using the validated Chinese scales of the Physical Exercise Self-efficacy Scale (PESES), a 5-item instrument with a 4-point Likert-type scale, ranging from 5 to 20. Higher scores shows higher routine physical exercise self-efficacy.	3rd test: after 6-month follow up
Nutrition Self-efficacy (pre-test)	Assessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).	Pre-test (1st test): before intervention
Nutrition Self-efficacy (2nd test)	Assessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).	2nd test: after 3-month intervention
Nutrition Self-efficacy (3rd test)	Assessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).	3rd test: after 6-month follow up
Nutritional Status (pre-test)	Assessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.	Pre-test (1st test): before intervention
Nutritional Status (2nd test)	Assessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.	2nd test: after 3-month intervention
Nutritional Status (3rd test)	Assessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.	3rd test: after 6-month follow up

Collaborators and Investigators

• Sponsor: Hong Kong Baptist University
• Collaborators: The Hong Kong Polytechnic University; Tung Wah College; Research Grants Council, Hong Kong; Coburg University of Applied Sciences and Arts; Constructor University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 15, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Older adults; Exercise training; Psychosocial support; Nutrition education; Intervention programs; Multi-dimensional frailty; Biopsychosocial approach
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 12600824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In the application of university human ethics, the investigators have declared non-disclosure of individual data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No