Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06741878

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Frailty in Older Adults

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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).

  12. 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).

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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).

  9. 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).

  10. 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.

  11. 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.

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiao JIAO, PhD

CONTACT

[email protected]

(852)34117005

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Collaborators

  • Coburg University of Applied Sciences and Arts
  • Constructor University
  • Research Grants Council, Hong Kong
  • The Hong Kong Polytechnic University
  • Tung Wah College

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.