Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06741878

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
308 (estimated)
Sponsor
Hong Kong Baptist University · Academic / Other
Sex
All
Age
60 Years – 80 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExerciseInvolves participants engaging in physical training group sessions in light-to-moderate intensity.
BEHAVIORALPsychosocialInvolves participants engaging in selected board and card games which require cognitive and socialization skills to play in a group setting of 2-4 people.
BEHAVIORALNutritionalInvolves participants attending dietary classes taught by a certified dietitian, including individualized consultation.

Timeline

Start date
2025-01-01
Primary completion
2026-03-31
Completion
2026-06-30
First posted
2024-12-19
Last updated
2024-12-19

Source: ClinicalTrials.gov record NCT06741878. Inclusion in this directory is not an endorsement.