Frailty in Older AdultsNCT06741878
A Biopsychosocial Approach to Improving Multidimensional Frailty Status in Community-Dwelling Older Adults
A study testing Exercise, Psychosocial and Nutritional in people with Frailty in Older Adults, run by Hong Kong Baptist University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty in Older Adults
- What is being tested?
- Exercise, Psychosocial and Nutritional
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Frailty in Older Adults
- Being tested
- Exercise, Psychosocial, Nutritional
- Keywords
- Multi-dimensional frailty, Biopsychosocial approach, Exercise training, Nutrition education, Psychosocial support, Older adults, Intervention programs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Involves participants engaging in physical training group sessions in light-to-moderate intensity.
PsychosocialBehavioural
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.
NutritionalBehavioural
Involves participants attending dietary classes taught by a certified dietitian, including individualized consultation.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training (Biological) + Board Games (Psychosocial) + Diet Consultation (Nutritional) | Active comparator | Not described Receives: Behavioral: Exercise; Behavioral: Psychosocial; Behavioral: Nutritional |
| Exercise Training (Biological) + Diet Consultation (Nutritional) | Active comparator | Not described Receives: Behavioral: Exercise; Behavioral: Nutritional |
| Board Games (Psychosocial) + Diet Consultation (Nutritional) | Active comparator | Not described Receives: Behavioral: Psychosocial; Behavioral: Nutritional |
| Inactive Control (No Treatment) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3rd test: after 6-month follow up
Secondary outcomes (12)
Physical Activity Behavioural Changes (pre-test)
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.
Measured: Pre-test (1st test): before intervention
Physical Activity Behavioural Changes (2nd test)
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.
Measured: 2nd test: after 3-month intervention
Physical Activity Behavioural Changes (3rd test)
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.
Measured: 3rd test: after 6-month follow up
Exercise Self-efficacy (pre-test)
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.
Measured: Pre-test (1st test): before intervention
Exercise Self-efficacy (2nd test)
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.
Measured: 2nd test: after 3-month intervention
Exercise Self-efficacy (3rd test)
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.
Measured: 3rd test: after 6-month follow up
Nutrition Self-efficacy (pre-test)
Assessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).
Measured: Pre-test (1st test): before intervention
Nutrition Self-efficacy (2nd test)
Assessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).
Measured: 2nd test: after 3-month intervention
Nutrition Self-efficacy (3rd test)
Assessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).
Measured: 3rd test: after 6-month follow up
Nutritional Status (pre-test)
Assessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.
Measured: Pre-test (1st test): before intervention
Nutritional Status (2nd test)
Assessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.
Measured: 2nd test: after 3-month intervention
Nutritional Status (3rd test)
Assessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.
Measured: 3rd test: after 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty in Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- Coburg University of Applied Sciences and Arts, The Hong Kong Polytechnic University, Tung Wah College, Research Grants Council, Hong Kong, Constructor University
- Responsible party
- Principal investigator, JIAO Jiao, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741878
- Sponsor's protocol ID
- 12600824
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the application of university human ethics, the investigators have declared non-disclosure of individual data.
Publications
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.
PubMed 40665217
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biopsychosocial Approach to Improving Multidimensional Frailty Status in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT06741878
- Acronym / sponsor ID
- 12600824
- Conditions
- Frailty in Older Adults
- Keywords
- Multi-dimensional frailty, Biopsychosocial approach, Exercise training, Nutrition education, Psychosocial support, Older adults, Intervention programs
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- Coburg University of Applied Sciences and Arts, The Hong Kong Polytechnic University, Tung Wah College, Research Grants Council, Hong Kong, Constructor University
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseInvolves participants engaging in physical training group sessions in light-to-moderate intensity. | Behavioural | Exercise Training (Biological) + Board Games (Psychosocial) + Diet Consultation (Nutritional), Exercise Training (Biological) + Diet Consultation (Nutritional) |
| PsychosocialInvolves participants engaging in selected board and card games which require cognitive and socialization skills to play in a group setting of 2-4 people. | Behavioural | Board Games (Psychosocial) + Diet Consultation (Nutritional), Exercise Training (Biological) + Board Games (Psychosocial) + Diet Consultation (Nutritional) |
| NutritionalInvolves participants attending dietary classes taught by a certified dietitian, including individualized consultation. | Behavioural | Board Games (Psychosocial) + Diet Consultation (Nutritional), Exercise Training (Biological) + Board Games (Psychosocial) + Diet Consultation (Nutritional), Exercise Training (Biological) + Diet Consultation (Nutritional) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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.
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.
12 secondary outcomes
Physical Activity Behavioural Changes (pre-test)
Time frame: Pre-test (1st test): before intervention
Physical Activity Behavioural Changes (2nd test)
Time frame: 2nd test: after 3-month intervention
Physical Activity Behavioural Changes (3rd test)
Time frame: 3rd test: after 6-month follow up
Exercise Self-efficacy (pre-test)
Time frame: Pre-test (1st test): before intervention
Exercise Self-efficacy (2nd test)
Time frame: 2nd test: after 3-month intervention
Exercise Self-efficacy (3rd test)
Time frame: 3rd test: after 6-month follow up
Nutrition Self-efficacy (pre-test)
Time frame: Pre-test (1st test): before intervention
Nutrition Self-efficacy (2nd test)
Time frame: 2nd test: after 3-month intervention
Nutrition Self-efficacy (3rd test)
Time frame: 3rd test: after 6-month follow up
Nutritional Status (pre-test)
Time frame: Pre-test (1st test): before intervention
Nutritional Status (2nd test)
Time frame: 2nd test: after 3-month intervention
Nutritional Status (3rd test)
Time frame: 3rd test: after 6-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Derived from this study: PubMed 40665217Jiao 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.
- Individual participant dataSharing planned: No. In the application of university human ethics, the investigators have declared non-disclosure of individual data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Psychosocial and Nutritional in people with Frailty in Older Adults, run by Hong Kong Baptist University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiao JIAO, PhD ((852)34117005, jojojiao@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Status (pre-test) (time frame: Pre-test (1st test): before intervention). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06741878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.