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

NCT06741878 | Not Yet Recruiting

• 1 other identifier: 12600824
• Study Type: interventional
• Target: 308
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frailty in Older Adults

Keywords

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

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (12)

• Physical Activity Behavioural Changes (pre-test)

  Pre-test (1st test): before intervention

• Physical Activity Behavioural Changes (2nd test)

  2nd test: after 3-month intervention

• Physical Activity Behavioural Changes (3rd test)

  3rd test: after 6-month follow up

• Exercise Self-efficacy (pre-test)

  Pre-test (1st test): before intervention

• Exercise Self-efficacy (2nd test)

  2nd test: after 3-month intervention

Study Arms (4)

Exercise Training (Biological) + Board Games (Psychosocial) + Diet Consultation (Nutritional)

ACTIVE COMPARATOR

Behavioral: Exercise; Behavioral: Psychosocial; Behavioral: Nutritional

Exercise Training (Biological) + Diet Consultation (Nutritional)

ACTIVE COMPARATOR

Behavioral: Exercise; Behavioral: Nutritional

Board Games (Psychosocial) + Diet Consultation (Nutritional)

ACTIVE COMPARATOR

Behavioral: Psychosocial; Behavioral: Nutritional

Inactive Control (No Treatment)

NO INTERVENTION

Interventions

Exercise BEHAVIORAL

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

Exercise Training (Biological) + Board Games (Psychosocial) + Diet Consultation (Nutritional); Exercise Training (Biological) + Diet Consultation (Nutritional)

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.

Board Games (Psychosocial) + Diet Consultation (Nutritional); Exercise Training (Biological) + Board Games (Psychosocial) + Diet Consultation (Nutritional)

Nutritional BEHAVIORAL

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

Board Games (Psychosocial) + Diet Consultation (Nutritional); Exercise Training (Biological) + Board Games (Psychosocial) + Diet Consultation (Nutritional); Exercise Training (Biological) + Diet Consultation (Nutritional)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• 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

Related Publications (1)

• Jiao J, Man DW, Lippke S, Hassel H, Tam BT, Chan CH, Ng YL, Lo KK. A biopsychosocial approach to improving multidimensional frailty status in community-dwelling older adults: a protocol for a cluster randomized controlled trial. BMC Geriatr. 2025 Jul 15;25(1):530. doi: 10.1186/s12877-025-06053-x.

  PMID: 40665217 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jiao JIAO, PhD

CONTACT

(852)34117005; jojojiao@hkbu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 19, 2024
• Study Start: January 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share