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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06741878
Enrollment
308
Registered
2024-12-19
Start date
2025-01-01
Completion date
2026-06-30
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty in Older Adults

Keywords

Multi-dimensional frailty, Biopsychosocial approach, Exercise training, Nutrition education, Psychosocial support, Older adults, Intervention programs

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.

Interventions

BEHAVIORALExercise

Involves participants engaging in physical training group sessions in light-to-moderate intensity.

BEHAVIORALPsychosocial

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.

BEHAVIORALNutritional

Involves participants attending dietary classes taught by a certified dietitian, including individualized consultation.

Sponsors

Coburg University of Applied Sciences and Arts
CollaboratorUNKNOWN
The Hong Kong Polytechnic University
CollaboratorOTHER
Tung Wah College
CollaboratorOTHER
Research Grants Council, Hong Kong
CollaboratorOTHER
Constructor University
CollaboratorUNKNOWN
Hong Kong Baptist University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Social Function (3rd test)3rd test: after 6-month follow upThe risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.
Physical Functioning-- Anthropometric Data (3rd test)3rd test: after 6-month follow upAnthropometric data (e.g. BMI in kg/m\^2) will be evaluated in 3 time frames, respectively.
Physical Functioning-- Health Related Information (pre-test)Pre-test (1st test): before interventionHealth-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.
Physical Functioning-- Health Related Information (2nd test)2nd test: after 3-month interventionHealth-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.
Physical Functioning-- Health Related Information (3rd test)3rd test: after 6-month follow upHealth-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.
Physical Functioning-- Senior Physical Fitness Test Battery (pre-test)Pre-test (1st test): before interventionThe 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).
Physical Functioning-- Senior Physical Fitness Test Battery (2nd test)2nd test: after 3-month interventionThe 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).
Physical Functioning-- Senior Physical Fitness Test Battery (3rd test)3rd test: after 6-month follow upThe 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).
Psychological Functioning (pre-test)Pre-test (1st test): before interventionA 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.
Psychological Functioning (2nd test)2nd test: after 3-month interventionA 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.
Psychological Functioning (3rd test)3rd test: after 6-month follow upA 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.
Social Function (pre-test)Pre-test (1st test): before interventionThe risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.
Social Function (2nd test)2nd test: after 3-month interventionThe risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.
Frailty Status (pre-test)Pre-test (1st test): before interventionThe 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.
Frailty Status (2nd test)2nd test: after 3-month interventionThe 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.
Frailty Status (3rd test)3rd test: after 6-month follow upThe 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.
Physical Functioning-- Anthropometic Data (pre-test)Pre-test (1st test): before interventionAnthropometric data (e.g. BMI in kg/m\^2) will be evaluated in 3 time frames, respectively.
Physical Functioning-- Anthropometric Data (2nd test)2nd test: after 3-month interventionAnthropometric data (e.g. BMI in kg/m\^2) will be evaluated in 3 time frames, respectively.

Secondary

MeasureTime frameDescription
Physical Activity Behavioural Changes (2nd test)2nd test: after 3-month interventionScales 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.
Physical Activity Behavioural Changes (3rd test)3rd test: after 6-month follow upScales 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.
Exercise Self-efficacy (pre-test)Pre-test (1st test): before interventionAssessed 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.
Exercise Self-efficacy (2nd test)2nd test: after 3-month interventionAssessed 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.
Exercise Self-efficacy (3rd test)3rd test: after 6-month follow upAssessed 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.
Nutrition Self-efficacy (pre-test)Pre-test (1st test): before interventionAssessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).
Nutrition Self-efficacy (2nd test)2nd test: after 3-month interventionAssessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).
Nutrition Self-efficacy (3rd test)3rd test: after 6-month follow upAssessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).
Nutritional Status (pre-test)Pre-test (1st test): before interventionAssessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.
Nutritional Status (2nd test)2nd test: after 3-month interventionAssessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.
Nutritional Status (3rd test)3rd test: after 6-month follow upAssessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.
Physical Activity Behavioural Changes (pre-test)Pre-test (1st test): before interventionScales 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.

Contacts

Primary ContactJiao JIAO, PhD
jojojiao@hkbu.edu.hk(852)34117005

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026