Frail Elderly PatientsNCT07136935
A Multicenter Observational Study of an Integrated Traditional Chinese and Western Medicine Care Model in Post-Acute Treatment of Frail Elderly Patients
A study testing Traditional Chinese Medicine treatment in people with Frail Elderly Patients, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Exploring the Impact and Effectiveness of an Integrated Traditional Chinese and Western Medicine Treatment Model in Post-Acute Care for Frail Older Patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Frail Elderly Patients
- What is being tested?
- Traditional Chinese Medicine treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jul 2025to 31 Mar 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients aged ≥75 years.
- A history of at least one of the following conditions: Parkinson's disease, chronic obstructive pulmonary disease (COPD), mild dementia, or chronic kidney disease at stage 3 or above.
- Hospitalized due to an acute illness (length of hospital stay >72 hours).
- Functional decline within one month after completion of treatment.
- Clinical Frailty Scale (CFS) score of 5-7 (indicating moderate or greater frailty, with retained rehabilitation potential).
- Can answer clinical questionnaires and scales.
Who cannot join
- Medically unstable (requiring intensive medical interventions, diagnostic testing, or supplemental oxygen).
- Unable to cooperate with treatment or communication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 403
About this study
Exploring the Impact and Effectiveness of an Integrated Traditional Chinese and Western Medicine Treatment Model in Post-Acute Care for Frail Older Patients.
Read the detailed description
Frailty Syndrome is a common syndrome in the geriatric population, with prevalence of 14% in a population of 65 years old and 26% in 85 years old. Clinically, frailty syndrome is associated with increased vulnerability, decreased physical strength and a decline in daily function. There are five main signs include low grip strength, low energy, slowed walking speed, low physical activity, and/or unintentional weight loss. Patients with frailty syndrome are more likely to experience adverse events such as falls, fractures, hospitalizations, and infections, which may even lead to increased mortality. The progression of frailty can significantly reduce patients' quality of life, and increase the medical burden along with burden on families and society.In the modern society as people live longer lives, the incidence of frailty syndrome is increasing year by year, and strategies for managing and delaying the frailty syndrome progression are warranted.
Traditional Chinese Medicine (TCM) is based on empirical clinical experience over thousands of years and long-established knowledge. It implements "syndrome differentiations" that are based on regulating the balance of Qi (energy) and blood in the body, restoring organ functions, and improving the body's self-regulation ability, through those concepts TCM provides a treatment potential. For frailty syndrome, TCM can play an important role in improving patients' physical strength, enhancing muscle strength, alleviating chronic inflammation, and improving quality of life.TCM has the advantages of simplicity, safety, and is suitable for the elderly. Therefore, the comprehensive treatment model of TCM not only provides a potentially effective intervention method for patients with frailty syndrome but also provides new approaches for the integrative management of geriatric diseases.
Methods: patients with mild to moderate frailty syndrome will be included in this study. Western physicians and Chinese medicine practitioners jointly evaluate those who are suitable for inclusion. The combined Chinese and Western medicine intervention will begin after informed consent signature by patients or their families. TCM interventions include acupuncture, herbal medicine/ herbal formulas, acupoint stimulation, TCM diet and lifestyle education, etc. The TCM doctor will determine the type of TCM intervention recommended based on the patient's needs and TCM diagnosis and discussion with Western medicine doctor. A total of 20 patients are expected to be admitted and case records will be recorded.
- Conditions
- Frail Elderly Patients
- Being tested
- Traditional Chinese Medicine treatment
- Keywords
- frailty, Chinese and Western Integrated medicine
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine treatmentDrug
- Oral Chinese herbal medicine or decoction: prescribe Chinese medicine based on syndrome differentiation and treatment of the patient's condition.
- Acupuncture or laser acupuncture treatment: Traditional Chinese medicine practitioners select acupuncture points to treat based on the patient's condition, and treat them once a week.
- Acupoint massage: Select treatment acupoints and techniques according to the patient's condition, 20 minutes at a time.
- Traditional Chinese Medicine Cake Acupoint Application: Warm Navel Cream to the CV-4 (Guanyuan) acupoint, the application time is 2 to 4 hours.
- Nursing and health education and guidance.
- Dietary hygiene education: personalized western nutrition and TCM dietary guidance suggestions based on TCM constitution syndromes.
- Lifestyle health education and sports rehabilitation: Playing Baduanjin, ten skilled hand exercise, and health preservation videos, and providing personalized TCM exercise recommendations.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 1. Oral Chinese herbal medicine or decoction
2. Acupuncture or laser acupuncture treatment
3. Acupoint massage
4. Traditional Chinese Medicine Cake Acupoint Application
5. Nursing and health education and guidance
6. Dietary hygiene education
7. Lifestyle health education and sports rehabilitation Receives: Drug: Traditional Chinese Medicine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of Osteoporotic Fractures
Measured by the Study of Osteoporotic Fractures (SOF Index) ,score of 0~2 : 0=robust,1 =prefrail,2= frail.
Measured: At baseline, End of treatment(4 weeks)
comprehensive geriatric assessment
Measured by comprehensive geriatric assessment(CGA)
Measured: At baseline, End of treatment(4 weeks)
Body Constitution Questionnaire / Constitution in Chinese Medicine Questionnaire
Measured by Body Constitution Questionnaire(BCQ) / Constitution in Chinese Medicine Questionnaire(CCMQ)
Measured: At baseline, End of treatment(4 weeks)
Secondary outcomes (5)
Height
height in cm.
Measured: At baseline, End of treatment(4 weeks)
Weight
weight in kilograms
Measured: At baseline, End of treatment(4 weeks)
Calf circumference
Keep your knee bent at a 90-degree angle, and measure the circumference of your calf at its widest point horizontally.
Measured: At baseline, End of treatment(4 weeks)
Grip strength
Use a handheld Jamar dynamometer in a sitting position with the elbow bent 90-degrees ,You can use either hand or your dominant hand. Record the highest value from two measurements.
Measured: At baseline, End of treatment(4 weeks)
Gait speed
6-m usual walking speed test
Measured: At baseline, End of treatment(4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start28 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly PatientsStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136935
- Sponsor's protocol ID
- CMUH114-REC2-105
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Study of an Integrated Traditional Chinese and Western Medicine Care Model in Post-Acute Treatment of Frail Elderly Patients
- ClinicalTrials.gov ID
- NCT07136935
- Acronym / sponsor ID
- CMUH114-REC2-105
- Conditions
- Frail Elderly Patients
- Keywords
- frailty, Chinese and Western Integrated medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Aug 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.
Exploring the Impact and Effectiveness of an Integrated Traditional Chinese and Western Medicine Treatment Model in Post-Acute Care for Frail Older Patients.
Detailed description
Frailty Syndrome is a common syndrome in the geriatric population, with prevalence of 14% in a population of 65 years old and 26% in 85 years old. Clinically, frailty syndrome is associated with increased vulnerability, decreased physical strength and a decline in daily function. There are five main signs include low grip strength, low energy, slowed walking speed, low physical activity, and/or unintentional weight loss. Patients with frailty syndrome are more likely to experience adverse events such as falls, fractures, hospitalizations, and infections, which may even lead to increased mortality. The progression of frailty can significantly reduce patients' quality of life, and increase the medical burden along with burden on families and society.In the modern society as people live longer lives, the incidence of frailty syndrome is increasing year by year, and strategies for managing and delaying the frailty syndrome progression are warranted.
Traditional Chinese Medicine (TCM) is based on empirical clinical experience over thousands of years and long-established knowledge. It implements "syndrome differentiations" that are based on regulating the balance of Qi (energy) and blood in the body, restoring organ functions, and improving the body's self-regulation ability, through those concepts TCM provides a treatment potential. For frailty syndrome, TCM can play an important role in improving patients' physical strength, enhancing muscle strength, alleviating chronic inflammation, and improving quality of life.TCM has the advantages of simplicity, safety, and is suitable for the elderly. Therefore, the comprehensive treatment model of TCM not only provides a potentially effective intervention method for patients with frailty syndrome but also provides new approaches for the integrative management of geriatric diseases.
Methods: patients with mild to moderate frailty syndrome will be included in this study. Western physicians and Chinese medicine practitioners jointly evaluate those who are suitable for inclusion. The combined Chinese and Western medicine intervention will begin after informed consent signature by patients or their families. TCM interventions include acupuncture, herbal medicine/ herbal formulas, acupoint stimulation, TCM diet and lifestyle education, etc. The TCM doctor will determine the type of TCM intervention recommended based on the patient's needs and TCM diagnosis and discussion with Western medicine doctor. A total of 20 patients are expected to be admitted and case records will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Traditional Chinese Medicine treatment1. Oral Chinese herbal medicine or decoction 2. Acupuncture or laser acupuncture treatment 3. Acupoint massage 4. Traditional Chinese Medicine Cake Acupoint Application 5. Nursing and health education and guidance 6. Dietary hygiene education 7. Lifestyle health education and sports rehabilitation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Elderly patients aged ≥75 years.
- A history of at least one of the following conditions: Parkinson's disease, chronic obstructive pulmonary disease (COPD), mild dementia, or chronic kidney disease at stage 3 or above.
- Hospitalized due to an acute illness (length of hospital stay >72 hours).
- Functional decline within one month after completion of treatment.
- Clinical Frailty Scale (CFS) score of 5-7 (indicating moderate or greater frailty, with retained rehabilitation potential).
Key exclusion criteria (2 listed)
- Medically unstable (requiring intensive medical interventions, diagnostic testing, or supplemental oxygen).
- Unable to cooperate with treatment or communication.
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 |
|---|---|---|
| Traditional Chinese Medicine treatment1. Oral Chinese herbal medicine or decoction: prescribe Chinese medicine based on syndrome differentiation and treatment of the patient's condition. 2. Acupuncture or laser acupuncture treatment: Traditional Chinese medicine practitioners select acupuncture points to treat based on the patient's condition, and treat them once a week. 3. Acupoint massage: Select treatment acupoints and techniques according to the patient's condition, 20 minutes at a time. 4. Traditional Chinese Medicine Cake Acupoint Application: Warm Navel Cream to the CV-4 (Guanyuan) acupoint, the application time is 2 to 4 hours. 5. Nursing and health education and guidance. 6. Dietary hygiene education: personalized western nutrition and TCM dietary guidance suggestions based on TCM constitution syndromes. 7. Lifestyle health education and sports rehabilitation: Playing Baduanjin, ten skilled hand exercise, and health preservation videos, and providing personalized TCM exercise recommendations. | Drug | intervention group |
Primary outcome
Study of Osteoporotic Fractures
Time frame: At baseline, End of treatment(4 weeks)
Measured by the Study of Osteoporotic Fractures (SOF Index) ,score of 0~2 : 0=robust,1 =prefrail,2= frail.
comprehensive geriatric assessment
Time frame: At baseline, End of treatment(4 weeks)
Measured by comprehensive geriatric assessment(CGA)
Body Constitution Questionnaire / Constitution in Chinese Medicine Questionnaire
Time frame: At baseline, End of treatment(4 weeks)
Measured by Body Constitution Questionnaire(BCQ) / Constitution in Chinese Medicine Questionnaire(CCMQ)
5 secondary outcomes
Height
Time frame: At baseline, End of treatment(4 weeks)
Weight
Time frame: At baseline, End of treatment(4 weeks)
Calf circumference
Time frame: At baseline, End of treatment(4 weeks)
Grip strength
Time frame: At baseline, End of treatment(4 weeks)
Gait speed
Time frame: At baseline, End of treatment(4 weeks)
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 22 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese Medicine treatment in people with Frail Elderly Patients, run by China Medical University Hospital at 1 site in Taiwan.
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 2 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yu-Chen Lee (886-4-22052121 ext. 14564, 005167@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of Osteoporotic Fractures (time frame: At baseline, End of treatment(4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025.