ElderlyNCT06919575
A Individualized Physical Function Improvement Program for Frailty Elderly Using Goal Attainment Scaling (GAS) as Evaluation Method: Protocol for a Randomized Controlled Trial
A study testing Multicomponent frailty intervention in people with Elderly, run by Beijing Chao Yang Hospital.
Trial summary
Frailty refers to the age-related decline in physiological functions，that is associated with adverse outcomes. Frailty is a dynamic reversible state, that requires a comprehensive individualized management. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly
- What is being tested?
- Multicomponent frailty intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Aug 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
The inclusion criteria were the following: (1)≥60-years old; (2) recognized as frailty by Fried scale.
The exclusion criteria were the following: (1) considered with life expectancy < 1 year such as advanced cancer patients; (2) difficult to communicate with such as patients with severe cognitive impairment (Mini Mental State Examination score ≤ 17); (3) severe hearing disord.
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 refers to the age-related decline in physiological functions，that is associated with adverse outcomes. Frailty is a dynamic reversible state, that requires a comprehensive individualized management. Goal Attainment Scaling (GAS) is a structured, individualized method for setting and evaluating progress toward personalized goals.
We conducted a randomized clinical trial of an individualized intervention program using GAS as evaluation method designed to improve physical functional in frailty elderly. A total of 160 individuals aged ≥60 years, who fulfill the Fried scale of frailty will be recruited from Beijing Chaoyang Hospital, Capital Medical University. All participants set personalized goals through GAS. Patients in the intervention group receive individualized interventions, implement tailored measures based on personalized goals to reverse the frailty state.The participants will be followed-up for 3 months and 24 months.
This protocol would be established to examine the efficiency of targeted individualized intervention for frailty based on the GAS. If a positive consequence could be obtained, the results of this study will provide critical data for management of frailty in the elderly, that can be carried out in routine clinical practice.
- Conditions
- Elderly
- Being tested
- Multicomponent frailty intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent frailty interventionCombination product
First, the underlying causes of the patient's frailty should be analyzed. Individualized goals should be established using Goal Attainment Scaling (GAS), followed by implementation of tailored measures. For patients presenting with malnutrition or mood-related disorders, comprehensive nutritional and psychological assessments must be conducted, with subsequent nutritional support or pharmacological treatment initiated when clinically indicated.
The patients of the intervention group with poor physical function would receive exercise prescription tailored to the subjects' physical ability from a trained specialist. For Participants requiring exercise-based interventions, a moderate and gradually increasing intensity exercise regimen home-basethree times a week, over a 12-week duration will be administer under telehealth-based monitoring.
| Study group | Role | What they receive |
|---|---|---|
| the intervention group | Experimental | the intervention group will receive individualized interventions. Receives: Combination Product: Multicomponent frailty intervention |
| The control group | No intervention | The control group will receive routine diagnosis and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scaling (GAS) Formulation of intervention objectives and attainment of goals was assessed using the Goal Attainment Scaling (GAS). GAS is a structured, individualized method for setting and evaluating progress toward personalized goals.
A pool of potential goals was developed by the research team based on the International Classification of Functioning, Disability, and Health (ICF). Each participants selected three goals through collaborative discussions among physicians, the individual, and caregivers. Participants were actively involved in the goal-setting and goal-rating process with the guidance of the research team. Participants also should weigh their goals by importance and difficulty at baseline. Goals were weighted by multiplying the importance level and the anticipated difficulty level, both graded on a 0-3 scale. For each goal, create a 5-point scale(-2 to +2) to describe potential outcomes: -2: Much worse than expected;-1: Somewhat worse than expected; 0: Expected level of success;+1: Somewhat better than expected; +2: Much better than expected. An aggregated T score with a mean of 50 and an SD of 10 was obtained.The extent to which goals are achieved is standardised into a T score by the formula
Measured: The GAS score was calculated according to a standardized formula and assessed at baseline, 3 months, and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Aug 2027 (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 ElderlyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919575
- Sponsor's protocol ID
- CYYY-Frailty-GAS
- Status last verified
- Jan 2025
- First submitted
- 2 Apr 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang Y, Qi ZC, Guo MT, Wang XJ. An individualized physical function improvement program for frailty elderly using goal attainment scaling (GAS) as evaluation method: protocol for a randomized controlled trial. BMC Geriatr. 2025 Jul 15;25(1):528. doi: 10.1186/s12877-025-06203-1.
PubMed 40665225
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Individualized Physical Function Improvement Program for Frailty Elderly Using Goal Attainment Scaling (GAS) as Evaluation Method: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06919575
- Acronym / sponsor ID
- CYYY-Frailty-GAS
- Conditions
- Elderly
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 9 Apr 2025 (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 refers to the age-related decline in physiological functions，that is associated with adverse outcomes. Frailty is a dynamic reversible state, that requires a comprehensive individualized management. Goal Attainment Scaling (GAS) is a structured, individualized method for setting and evaluating progress toward personalized goals.
We conducted a randomized clinical trial of an individualized intervention program using GAS as evaluation method designed to improve physical functional in frailty elderly. A total of 160 individuals aged ≥60 years, who fulfill the Fried scale of frailty will be recruited from Beijing Chaoyang Hospital, Capital Medical University. All participants set personalized goals through GAS. Patients in the intervention group receive individualized interventions, implement tailored measures based on personalized goals to reverse the frailty state.The participants will be followed-up for 3 months and 24 months.
This protocol would be established to examine the efficiency of targeted individualized intervention for frailty based on the GAS. If a positive consequence could be obtained, the results of this study will provide critical data for management of frailty in the elderly, that can be carried out in routine clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the intervention group | Experimental | Combination Product: Multicomponent frailty interventionthe intervention group will receive individualized interventions. |
| The control group | No intervention | –The control group will receive routine diagnosis and treatment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Multicomponent frailty interventionFirst, the underlying causes of the patient's frailty should be analyzed. Individualized goals should be established using Goal Attainment Scaling (GAS), followed by implementation of tailored measures. For patients presenting with malnutrition or mood-related disorders, comprehensive nutritional and psychological assessments must be conducted, with subsequent nutritional support or pharmacological treatment initiated when clinically indicated. The patients of the intervention group with poor physical function would receive exercise prescription tailored to the subjects' physical ability from a trained specialist. For Participants requiring exercise-based interventions, a moderate and gradually increasing intensity exercise regimen home-basethree times a week, over a 12-week duration will be administer under telehealth-based monitoring. | Combination product | the intervention group |
Primary outcome
Goal Attainment Scaling (GAS) Formulation of intervention objectives and attainment of goals was assessed using the Goal Attainment Scaling (GAS). GAS is a structured, individualized method for setting and evaluating progress toward personalized goals.
Time frame: The GAS score was calculated according to a standardized formula and assessed at baseline, 3 months, and 24 months.
A pool of potential goals was developed by the research team based on the International Classification of Functioning, Disability, and Health (ICF). Each participants selected three goals through collaborative discussions among physicians, the individual, and caregivers. Participants were actively involved in the goal-setting and goal-rating process with the guidance of the research team. Participants also should weigh their goals by importance and difficulty at baseline. Goals were weighted by multiplying the importance level and the anticipated difficulty level, both graded on a 0-3 scale. For each goal, create a 5-point scale(-2 to +2) to describe potential outcomes: -2: Much worse than expected;-1: Somewhat worse than expected; 0: Expected level of success;+1: Somewhat better than expected; +2: Much better than expected. An aggregated T score with a mean of 50 and an SD of 10 was obtained.The extent to which goals are achieved is standardised into a T score by the formula
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 9 Apr 2025.
- Derived from this study: PubMed 40665225Kang Y, Qi ZC, Guo MT, Wang XJ. An individualized physical function improvement program for frailty elderly using goal attainment scaling (GAS) as evaluation method: protocol for a randomized controlled trial. BMC Geriatr. 2025 Jul 15;25(1):528. doi: 10.1186/s12877-025-06203-1.
- Individual participant dataSharing planned: No
Related trials for Elderly
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Recruiting
SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
Depressive Disorder, Treatment-Resistant, Memory Deficits
RecruitingPhase 2
Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
Active, not recruiting
Deliver-EE: Evaluating Effects of Meal Delivery
Healthy
Not yet recruiting
Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler.
Hemorrhage, Healthy Volunteers
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 Multicomponent frailty intervention in people with Elderly, run by Beijing Chao Yang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Apr 2025. 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 xiaojuan Wang, PHD (86 13641159814, xjwang730715@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scaling (GAS) Formulation of intervention objectives and attainment of goals was assessed using the Goal Attainment Scaling (GAS). GAS is a structured, individualized method for setting and evaluating progress toward personalized goals. (time frame: The GAS score was calculated according to a standardized formula and assessed at baseline, 3 months, and 24 months.). 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 NCT06919575, 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 9 Apr 2025.