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

December 15, 2024 updated by: JIAO Jiao, Hong Kong Baptist University
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
308

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frailty Status (pre-test)
Time Frame: Pre-test (1st test): before intervention
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)
Time Frame: 2nd test: after 3-month intervention
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)
Time Frame: 3rd test: after 6-month follow up
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)
Time Frame: Pre-test (1st test): before intervention
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)
Time Frame: 2nd test: after 3-month intervention
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)
Time Frame: 3rd test: after 6-month follow up
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)
Time Frame: Pre-test (1st test): before intervention
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)
Time Frame: 2nd test: after 3-month intervention
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)
Time Frame: 3rd test: after 6-month follow up
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)
Time Frame: Pre-test (1st test): before intervention
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)
Time Frame: 2nd test: after 3-month intervention
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)
Time Frame: 3rd test: after 6-month follow up
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)
Time Frame: Pre-test (1st test): before intervention
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)
Time Frame: 2nd test: after 3-month intervention
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)
Time Frame: 3rd test: after 6-month follow up
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)
Time Frame: Pre-test (1st test): before intervention
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)
Time Frame: 2nd test: after 3-month intervention
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)
Time Frame: 3rd test: after 6-month follow up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical Activity Behavioural Changes (pre-test)
Time Frame: Pre-test (1st test): before intervention
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)
Time Frame: 2nd test: after 3-month intervention
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)
Time Frame: 3rd test: after 6-month follow up
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)
Time Frame: Pre-test (1st test): before intervention
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)
Time Frame: 2nd test: after 3-month intervention
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)
Time Frame: 3rd test: after 6-month follow up
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)
Time Frame: Pre-test (1st test): before intervention
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)
Time Frame: 2nd test: after 3-month intervention
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)
Time Frame: 3rd test: after 6-month follow up
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)
Time Frame: Pre-test (1st test): before intervention
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)
Time Frame: 2nd test: after 3-month intervention
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)
Time Frame: 3rd test: after 6-month follow up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hong Kong Baptist University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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