SarcopeniaNCT05926713
Evaluate the Effect of Dietary Supplement Combined Exercise Among Patients With Sarcopenia Comorbid With Lung Disease
A study testing Sarcojoint® and supervised exercise in people with Sarcopenia and COPD, run by Orient Europharma Co., Ltd. at 1 site in Taiwan.
Trial summary
This trial is a prospective multi-center study. The purpose of this study is to evaluate the effect of dietary supplement combined with supervised exercised on the physical performance, body composition and lung function among patients with Sarcopenia and severe Sarcopenia in chronic lung disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcopenia, COPD, ILD
- What is being tested?
- Sarcojoint® and supervised exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2023to 31 Oct 2032
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Outpatients with COPD (chronic obstructive pulmonary disease) or ILD (interstitial lung disease) from Department of Chest medicine in Taichung Veterans General Hospital, judged by the doctor that they do not need hospitalization or emergent treatment.
- Outpatients who meet the diagnostic criteria for Sarcopenia after evaluation by a physician.
Who cannot join
- Patients who refuse to sign the consent form
- Patients who are under 20 years old
- Patients who are bedridden or unable to walk due to physical disabilities
- Patients with terminal cancer or human-acquired immunodeficiency syndrome
- Patients with edema (grading pitting edema +2)
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
Taichung Veterans General Hospital
Taichung
Pin-Kuei Fu, PhD, 04-23592525 ext. 6536, yetquen@vghtc.gov.tw
About this study
Official title: Evaluate the Effect of Dietary Supplement Combined Supervised Exercise on Physical Performance and Body Composition Among Patients With Sarcopenia and Severe Sarcopenia Comorbid With COPD or ILD: A Prospective, Multi-center Cohort Study
This trial is a prospective multi-center study. The purpose of this study is to evaluate the effect of dietary supplement combined with supervised exercised on the physical performance, body composition and lung function among patients with Sarcopenia and severe Sarcopenia in chronic lung disease. After participants enroll in this study, 12-week clinical trial will be conducted to analyze the improvement regarding Sarcopenia and different severity of Sarcopenia before and after the intervention of exercise and nutritional products, which can further provide reference for clinical intervention and rehabilitation.
Read the detailed description
The design of clinical trial
This study is a prospective, multi-center, and non-invasive cohort study. All participants are diagnosed with COPD or ILD with Sarcopenia or severe Sarcopenia. The intervention consisted of providing nutritional supplements and supervised exercise for 12 weeks. After the intervention (the 12th week), the trial commissioned company provides nutritional supplements with a market price of about NT$4,000 per month for three months free to participants who are willing to continue taking the products. Those participants will be tracked for one year. The primary purpose of the study is to investigate improvement of physical performance, body composition and lung function before and after the intervention. The secondary purpose of the study is to compare the effect of the same intervention on Sarcopenia and different severity of Sarcopenia regarding the improvement of physical performance, body composition and lung function. Furthermore, the subgroup analysis is conducted to compare those who achieve the exercise requirement with those who do not concerning their physical performance, body composition and lung function.
Trail procedures
- Baseline demographic characteristic, health behavior and exercise habits are collected by questionnaires.
- The main disease diagnosis, medication, clinical assessment questionnaire or biochemical examination and radiological examination results are collected.
- According to the 2019 Asian Sarcopenia Consensus, participants are examined by SARC-Calf questionnaire, grip strength test and a physical performance test, including sit-stand test, short physical performance battery (SPPB), gait speed test and six-minute walk test. Afterward, bioelectrical impedance analysis (BIA) and Dual-energy X-ray absorptiometry (DXA) are applied to all participants to analyze body composition. Participants are classified into Sarcopenia group and severe Sarcopenia group.
- All patients receive pulmonary function test and blood test ( complete blood count, hepatic function, including [CHOL、TG、UA、SGOT、SGPT、ALK、BIL、TOTAL.BIL、DIRECT、LDH], renal function [BUN、CREAT、CA、CL、NA、K、T、P、ALB], Albumin, Vitamin D before and after the trail.
- All participants are administered Sarcojoint® containing leucinine 1 g, arginine 1.5 g, Vitamin D 7.5μg, chondroitin 400 mg, calcium 300 mg, and glucosamine 700 mg per package, and take 1 package twice a day.
- All participants are required to walk 6500 steps every day for 12 weeks, and the data are recorded by Xiaomi-smart-band.
- The research nurse provides health education and a recording handbook for exercise and dietary record to participants before the intervention. During the intervention, the research nurse tracks participants' compliance and records the adverse reaction by telephone interview at the first week, and every other week.
- At the 12th week, all participants receive a comprehensive functional assessment as that at baseline after intervention to investigate the intervention effect on different severity of Sarcopenia.
- At the 12th week, trial commissioned manufacturer provide nutritional supplements free for 3 months. Those patients will be continuously tracked for the follow-up data for the post hoc analysis.
- Conditions
- Sarcopenia, COPD, ILD
- Being tested
- Sarcojoint®, supervised exercise
- Medical subject headings
- Sarcopenia, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcojoint®Dietary supplement
All participants are administered Sarcojoint® containing leucinine 1 g, arginine 1.5 g, Vitamin D 7.5μg, chondroitin 400 mg, calcium 300 mg, and glucosamine 700 mg per package, and take 1 package twice a day.
supervised exerciseBehavioural
All participants are required to walk 6500 steps every day for 12 weeks, and the data are recorded by Xiaomi-smart-band.
| Study group | Role | What they receive |
|---|---|---|
| nutritional supplements and supervised exercise on Sarcopenia group and Severe Sarcopenia group | Experimental | The intervention consisted of providing nutritional supplements and supervised exercise for 12 weeks. After the intervention (the 12th week), the trial commissioned company provides nutritional supplements with a market price of about NT$4,000 per month for three months free to participants who are willing to continue taking the products. Those participants will be tracked for one year. Receives: Dietary Supplement: Sarcojoint®; Behavioral: supervised exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of physical performance (Grip strength)
Grip strength (kg) Instrument: Smedley dynamometer
Measured: 12 weeks
Change of physical performance(Sit to stand test) :SpO2%, HR, Borg score, times and second will be reported to present the result of Sit to stand test.
SpO2%, HR, Borg score, times and second
Measured: 12 weeks
Change of physical performance (SPPB): Sit to stand test, balance test and 4-meter walk test will be combined to report SPPB score
Sit to stand test, balance test and 4-meter walk test will be combined to report SPPB score
Measured: 12 weeks
Change of physical performance :6-meter walk test (second)
- 6-miniute walk test ( SpO2%, HR, Borg score, and the walking distance will be reported to present the result of 6-miniute walk test. )
Measured: 12 weeks
Change of physical performance :6-miniute walk test ( SpO2%, HR, Borg score, and the walking distance will be reported to present the result of 6-miniute walk test. )
SpO2%, HR, Borg score, and the walking distance
Measured: 12 weeks
Change of body composition: BMI(kg/m^2)
Measured: 12 weeks
Change of body composition: SMI (kg/m^2)
PBF (%), ASM (kg), LMM (kg), BMD (T-score), RASM (kg/m^2)
Measured: 12 weeks
PBF (%)
Change of body composition
Measured: 12 weeks
ASM (kg)
Change of body composition
Measured: 12 weeks
LMM (kg)
Change of body composition
Measured: 12 weeks
BMD (T-score)
Change of body composition
Measured: 12 weeks
RASM (kg/m^2)
Change of body composition
Measured: 12 weeks
Forced Expiratory Volume in 1 second(FEV1(L))
Change of lung function
Measured: 12 weeks
Forced Expiratory Volume in 1 second as a percentage of predicted value(FEV1 (%))
Change of lung function
Measured: 12 weeks
ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage(FEV1/FVC (%))
Change of lung function
Measured: 12 weeks
Peak Expiratory Flow(PEF (L/min))
Change of lung function
Measured: 12 weeks
RBC (/μL)
Complete blood count
Measured: 12 weeks
WBC (/μL)
Complete blood count
Measured: 12 weeks
PLT (/μL)
Complete blood count
Measured: 12 weeks
Hb
Complete blood count
Measured: 12 weeks
Hematocrit
Complete blood count
Measured: 12 weeks
TG
Hepatic function
Measured: 12 weeks
SGOT (U/L)
Hepatic function
Measured: 12 weeks
SGPT (U/L)
Hepatic function
Measured: 12 weeks
Total cholesterol(mg/dL)
Hepatic function
Measured: 12 weeks
LDL-C (mg/dL)
LDL-C (mg/dL)
Measured: 12 weeks
Fasting glucose (mg/dL)
Fasting glucose (mg/dL)
Measured: 12 weeks
HbA1c (%)
HbA1c (%)
Measured: 12 weeks
Total protein (g/dL)
Total protein (g/dL)
Measured: 12 weeks
Albumin (g/dL)
Albumin (g/dL)
Measured: 12 weeks
Renal function
BUN、CREAT(mg/dL)
Measured: 12 weeks
Hs-CRP
Hs-CRP
Measured: 12 weeks
Vitamin D
Vitamin D
Measured: 12 weeks
Secondary outcomes (12)
SARC-Calf questionnaire
compare the effect of the same intervention on Sarcopenia and different severity of Sarcopenia.
Measured: 12 weeks
Grip strength test
compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.
Measured: 12 weeks
Sit-stand test
compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.
Measured: 12 weeks
Short physical performance battery (SPPB)
compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.
Measured: 12 weeks
Gait speed test
compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.
Measured: 12 weeks
Six-minute walk test.
compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.
Measured: 12 weeks
Bioelectrical impedance analysis (BIA)
compare the effect of the same intervention on Sarcopenia and different severity of Sarcopenia on the outcome of body composition
Measured: 12 weeks
SMI (kg/m^2)
DXA is an X-ray machine that can generate two types of low-energy X-rays. X-rays of different energies are attenuated to different degrees by different media. The higher the density of the medium, the greater the attenuation caused by X-rays. Through computer calculations, DXA can not only measure bone density but also analyze body composition, determining the quantity and ratio of muscle and fat. Bone density: L-spine (g/cm^2) and T-score , Femoral neck (g/cm^2) and T-score
Measured: 12 weeks
Forced Expiratory Volume in 1 second (FEV1)
Pulmonary function
Measured: 12 weeks
Forced Expiratory Volume in 1 second as a percentage of predicted value (FEV1 (%))
Pulmonary function
Measured: 12 weeks
ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage (FEV1/FVC (%))
Pulmonary function
Measured: 12 weeks
Peak Expiratory Flow (PEF (L/min))
Pulmonary function
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Mar 2023
- Primary completion31 Oct 2032 (estimated)
- Study completion31 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orient Europharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pin-Kuei Fu, Principal investigator, Department of Chest Medicine of Taichung Veterans General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926713
- Sponsor's protocol ID
- OEP-Sarcojoint
- Status last verified
- Jun 2023
- First submitted
- 22 Nov 2022
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effect of Dietary Supplement Combined Supervised Exercise on Physical Performance and Body Composition Among Patients With Sarcopenia and Severe Sarcopenia Comorbid With COPD or ILD: A Prospective, Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT05926713
- Acronym / sponsor ID
- OEP-Sarcojoint
- Conditions
- Sarcopenia, COPD, ILD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Orient Europharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Oct 2032 (estimated)
- Study completion
- 31 Oct 2032 (estimated)
- First posted
- 3 Jul 2023 (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.
This trial is a prospective multi-center study. The purpose of this study is to evaluate the effect of dietary supplement combined with supervised exercised on the physical performance, body composition and lung function among patients with Sarcopenia and severe Sarcopenia in chronic lung disease. After participants enroll in this study, 12-week clinical trial will be conducted to analyze the improvement regarding Sarcopenia and different severity of Sarcopenia before and after the intervention of exercise and nutritional products, which can further provide reference for clinical intervention and rehabilitation.
Detailed description
The design of clinical trial
This study is a prospective, multi-center, and non-invasive cohort study. All participants are diagnosed with COPD or ILD with Sarcopenia or severe Sarcopenia. The intervention consisted of providing nutritional supplements and supervised exercise for 12 weeks. After the intervention (the 12th week), the trial commissioned company provides nutritional supplements with a market price of about NT$4,000 per month for three months free to participants who are willing to continue taking the products. Those participants will be tracked for one year. The primary purpose of the study is to investigate improvement of physical performance, body composition and lung function before and after the intervention. The secondary purpose of the study is to compare the effect of the same intervention on Sarcopenia and different severity of Sarcopenia regarding the improvement of physical performance, body composition and lung function. Furthermore, the subgroup analysis is conducted to compare those who achieve the exercise requirement with those who do not concerning their physical performance, body composition and lung function.
Trail procedures
- Baseline demographic characteristic, health behavior and exercise habits are collected by questionnaires.
- The main disease diagnosis, medication, clinical assessment questionnaire or biochemical examination and radiological examination results are collected.
- According to the 2019 Asian Sarcopenia Consensus, participants are examined by SARC-Calf questionnaire, grip strength test and a physical performance test, including sit-stand test, short physical performance battery (SPPB), gait speed test and six-minute walk test. Afterward, bioelectrical impedance analysis (BIA) and Dual-energy X-ray absorptiometry (DXA) are applied to all participants to analyze body composition. Participants are classified into Sarcopenia group and severe Sarcopenia group.
- All patients receive pulmonary function test and blood test ( complete blood count, hepatic function, including [CHOL、TG、UA、SGOT、SGPT、ALK、BIL、TOTAL.BIL、DIRECT、LDH], renal function [BUN、CREAT、CA、CL、NA、K、T、P、ALB], Albumin, Vitamin D before and after the trail.
- All participants are administered Sarcojoint® containing leucinine 1 g, arginine 1.5 g, Vitamin D 7.5μg, chondroitin 400 mg, calcium 300 mg, and glucosamine 700 mg per package, and take 1 package twice a day.
- All participants are required to walk 6500 steps every day for 12 weeks, and the data are recorded by Xiaomi-smart-band.
- The research nurse provides health education and a recording handbook for exercise and dietary record to participants before the intervention. During the intervention, the research nurse tracks participants' compliance and records the adverse reaction by telephone interview at the first week, and every other week.
- At the 12th week, all participants receive a comprehensive functional assessment as that at baseline after intervention to investigate the intervention effect on different severity of Sarcopenia.
- At the 12th week, trial commissioned manufacturer provide nutritional supplements free for 3 months. Those patients will be continuously tracked for the follow-up data for the post hoc analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nutritional supplements and supervised exercise on Sarcopenia group and Severe Sarcopenia group | Experimental | Dietary Supplement: Sarcojoint®, Behavioral: supervised exerciseThe intervention consisted of providing nutritional supplements and supervised exercise for 12 weeks. After the intervention (the 12th week), the trial commissioned company provides nutritional supplements with a market price of about NT$4,000 per month for three months free to participants who are willing to continue taking the products. Those participants will be tracked for one year. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients with COPD (chronic obstructive pulmonary disease) or ILD (interstitial lung disease) from Department of Chest medicine in Taichung Veterans General Hospital, judged by the doctor that they do not need hospitalization or emergent treatment.
- Outpatients who meet the diagnostic criteria for Sarcopenia after evaluation by a physician.
Key exclusion criteria (5 listed)
- Patients who refuse to sign the consent form
- Patients who are under 20 years old
- Patients who are bedridden or unable to walk due to physical disabilities
- Patients with terminal cancer or human-acquired immunodeficiency syndrome
- Patients with edema (grading pitting edema +2)
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 |
|---|---|---|
| Sarcojoint®All participants are administered Sarcojoint® containing leucinine 1 g, arginine 1.5 g, Vitamin D 7.5μg, chondroitin 400 mg, calcium 300 mg, and glucosamine 700 mg per package, and take 1 package twice a day. | Dietary supplement | nutritional supplements and supervised exercise on Sarcopenia group and Severe Sarcopenia group |
| supervised exerciseAll participants are required to walk 6500 steps every day for 12 weeks, and the data are recorded by Xiaomi-smart-band. | Behavioural | nutritional supplements and supervised exercise on Sarcopenia group and Severe Sarcopenia group |
Primary outcome
Change of physical performance (Grip strength)
Time frame: 12 weeks
Grip strength (kg) Instrument: Smedley dynamometer
Change of physical performance(Sit to stand test) :SpO2%, HR, Borg score, times and second will be reported to present the result of Sit to stand test.
Time frame: 12 weeks
SpO2%, HR, Borg score, times and second
Change of physical performance (SPPB): Sit to stand test, balance test and 4-meter walk test will be combined to report SPPB score
Time frame: 12 weeks
Sit to stand test, balance test and 4-meter walk test will be combined to report SPPB score
Change of physical performance :6-meter walk test (second)
Time frame: 12 weeks
5. 6-miniute walk test ( SpO2%, HR, Borg score, and the walking distance will be reported to present the result of 6-miniute walk test. )
Change of physical performance :6-miniute walk test ( SpO2%, HR, Borg score, and the walking distance will be reported to present the result of 6-miniute walk test. )
Time frame: 12 weeks
SpO2%, HR, Borg score, and the walking distance
Change of body composition: BMI(kg/m^2)
Time frame: 12 weeks
Change of body composition: SMI (kg/m^2)
Time frame: 12 weeks
PBF (%), ASM (kg), LMM (kg), BMD (T-score), RASM (kg/m^2)
PBF (%)
Time frame: 12 weeks
Change of body composition
ASM (kg)
Time frame: 12 weeks
Change of body composition
LMM (kg)
Time frame: 12 weeks
Change of body composition
BMD (T-score)
Time frame: 12 weeks
Change of body composition
RASM (kg/m^2)
Time frame: 12 weeks
Change of body composition
Forced Expiratory Volume in 1 second(FEV1(L))
Time frame: 12 weeks
Change of lung function
Forced Expiratory Volume in 1 second as a percentage of predicted value(FEV1 (%))
Time frame: 12 weeks
Change of lung function
ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage(FEV1/FVC (%))
Time frame: 12 weeks
Change of lung function
Peak Expiratory Flow(PEF (L/min))
Time frame: 12 weeks
Change of lung function
RBC (/μL)
Time frame: 12 weeks
Complete blood count
WBC (/μL)
Time frame: 12 weeks
Complete blood count
PLT (/μL)
Time frame: 12 weeks
Complete blood count
Hb
Time frame: 12 weeks
Complete blood count
Hematocrit
Time frame: 12 weeks
Complete blood count
TG
Time frame: 12 weeks
Hepatic function
SGOT (U/L)
Time frame: 12 weeks
Hepatic function
SGPT (U/L)
Time frame: 12 weeks
Hepatic function
Total cholesterol(mg/dL)
Time frame: 12 weeks
Hepatic function
LDL-C (mg/dL)
Time frame: 12 weeks
LDL-C (mg/dL)
Fasting glucose (mg/dL)
Time frame: 12 weeks
Fasting glucose (mg/dL)
HbA1c (%)
Time frame: 12 weeks
HbA1c (%)
Total protein (g/dL)
Time frame: 12 weeks
Total protein (g/dL)
Albumin (g/dL)
Time frame: 12 weeks
Albumin (g/dL)
Renal function
Time frame: 12 weeks
BUN、CREAT(mg/dL)
Hs-CRP
Time frame: 12 weeks
Hs-CRP
Vitamin D
Time frame: 12 weeks
Vitamin D
12 secondary outcomes
SARC-Calf questionnaire
Time frame: 12 weeks
Grip strength test
Time frame: 12 weeks
Sit-stand test
Time frame: 12 weeks
Short physical performance battery (SPPB)
Time frame: 12 weeks
Gait speed test
Time frame: 12 weeks
Six-minute walk test.
Time frame: 12 weeks
Bioelectrical impedance analysis (BIA)
Time frame: 12 weeks
SMI (kg/m^2)
Time frame: 12 weeks
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 12 weeks
Forced Expiratory Volume in 1 second as a percentage of predicted value (FEV1 (%))
Time frame: 12 weeks
ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage (FEV1/FVC (%))
Time frame: 12 weeks
Peak Expiratory Flow (PEF (L/min))
Time frame: 12 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 3 Jul 2023.
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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.
Pin-Kuei Fu principal investigator
Department of Chest Medicine of Taichung Veterans General
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sarcojoint® and supervised exercise in people with Sarcopenia and COPD, run by Orient Europharma Co., Ltd. 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 2 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: looking for participants now, as of the sponsor's last update on 3 Jul 2023. 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 Pin-Kuei Fu, PhD (04-23592525 ext. 6536, yetquen@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of physical performance (Grip strength) (time frame: 12 weeks). The study lists 33 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 3 Jul 2023.