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

NCT ID: NCT06741878

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Frailty in Older Adults

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

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

Psychosocial

Intervention Type 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

Intervention Type BEHAVIORAL

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

Exercise Training (Biological) + Diet Consultation (Nutritional)

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

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

Nutritional

Intervention Type BEHAVIORAL

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

Board Games (Psychosocial) + Diet Consultation (Nutritional)

Group Type ACTIVE_COMPARATOR

Psychosocial

Intervention Type 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

Intervention Type BEHAVIORAL

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

Inactive Control (No Treatment)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Nutritional

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coburg University of Applied Sciences and Arts

UNKNOWN

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role collaborator

Tung Wah College

OTHER

Sponsor Role collaborator

Research Grants Council, Hong Kong

OTHER

Sponsor Role collaborator

Constructor University

UNKNOWN

Sponsor Role collaborator

Hong Kong Baptist University

OTHER

Sponsor Role lead

Responsible Party

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JIAO Jiao

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jiao JIAO, PhD

Role: CONTACT

Phone: (852)34117005

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 40665217 (View on PubMed)

Other Identifiers

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12600824

Identifier Type: -

Identifier Source: org_study_id