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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorHong Kong Baptist University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Exercise

    Behavioral

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

  • Psychosocial

    Behavioral

    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.

  • Nutritional

    Behavioral

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

Treatment groups

308 Participants
are divided into 4 treatment groups
Group A: Exercise Training (Biological) + Board Games (Psychosocial) + Diet Consultation (Nutritional)Active comparator 3 interventions
Group B: Exercise Training (Biological) + Diet Consultation (Nutritional)Active comparator 2 interventions
Group C: Board Games (Psychosocial) + Diet Consultation (Nutritional)Active comparator 2 interventions
Group D: Inactive Control (No Treatment)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Pre-test (1st test): before intervention
2

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.

Time frame
2nd test: after 3-month intervention
3

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.

Time frame
3rd test: after 6-month follow up
4

Physical Functioning-- Anthropometic Data (pre-test)

Anthropometric data (e.g. BMI in kg/m\^2) will be evaluated in 3 time frames, respectively.

Time frame
Pre-test (1st test): before intervention

Secondary outcomes

1

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.

Time frame
Pre-test (1st test): before intervention
2

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.

Time frame
2nd test: after 3-month intervention
3

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.

Time frame
3rd test: after 6-month follow up
4

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.

Time frame
Pre-test (1st test): before intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hong Kong Baptist University

Lead sponsor

Coburg University of Applied Sciences and Arts

Collaborator

The Hong Kong Polytechnic University

Collaborator

Tung Wah College

Collaborator

Research Grants Council, Hong Kong

Collaborator

Constructor University

Collaborator

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