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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of physical performance (Grip strength) | Grip strength (kg) Instrument: Smedley dynamometer | 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 | 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 | 12 weeks |
| Change of physical performance :6-meter walk test (second) | 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. ) | 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 | 12 weeks |
| Change of body composition: BMI(kg/m^2) | 12 weeks | |
| Change of body composition: SMI (kg/m^2) | PBF (%), ASM (kg), LMM (kg), BMD (T-score), RASM (kg/m^2) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SARC-Calf questionnaire | compare the effect of the same intervention on Sarcopenia and different severity of Sarcopenia. | 12 weeks |
| Grip strength test | compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pin-Kuei Fu, PhD | Contact | 04-23592525 | 6536 | yetquen@vghtc.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Pin-Kuei Fu | Department of Chest Medicine of Taichung Veterans General | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Recruiting | Taichung | Taiwan |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| supervised exercise | Behavioral | All participants are required to walk 6500 steps every day for 12 weeks, and the data are recorded by Xiaomi-smart-band. |
|
| PBF (%) | Change of body composition | 12 weeks |
| ASM (kg) | Change of body composition | 12 weeks |
| LMM (kg) | Change of body composition | 12 weeks |
| BMD (T-score) | Change of body composition | 12 weeks |
| RASM (kg/m^2) | Change of body composition | 12 weeks |
| Forced Expiratory Volume in 1 second(FEV1(L)) | Change of lung function | 12 weeks |
| Forced Expiratory Volume in 1 second as a percentage of predicted value(FEV1 (%)) | Change of lung function | 12 weeks |
| ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage(FEV1/FVC (%)) | Change of lung function | 12 weeks |
| Peak Expiratory Flow(PEF (L/min)) | Change of lung function | 12 weeks |
| RBC (/μL) | Complete blood count | 12 weeks |
| WBC (/μL) | Complete blood count | 12 weeks |
| PLT (/μL) | Complete blood count | 12 weeks |
| Hb | Complete blood count | 12 weeks |
| Hematocrit | Complete blood count | 12 weeks |
| TG | Hepatic function | 12 weeks |
| SGOT (U/L) | Hepatic function | 12 weeks |
| SGPT (U/L) | Hepatic function | 12 weeks |
| Total cholesterol(mg/dL) | Hepatic function | 12 weeks |
| LDL-C (mg/dL) | LDL-C (mg/dL) | 12 weeks |
| Fasting glucose (mg/dL) | Fasting glucose (mg/dL) | 12 weeks |
| HbA1c (%) | HbA1c (%) | 12 weeks |
| Total protein (g/dL) | Total protein (g/dL) | 12 weeks |
| Albumin (g/dL) | Albumin (g/dL) | 12 weeks |
| Renal function | BUN、CREAT(mg/dL) | 12 weeks |
| Hs-CRP | Hs-CRP | 12 weeks |
| Vitamin D | Vitamin D | 12 weeks |
| 12 weeks |
| Sit-stand test | compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia. | 12 weeks |
| Short physical performance battery (SPPB) | compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia. | 12 weeks |
| Gait speed test | compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia. | 12 weeks |
| Six-minute walk test. | compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia. | 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 | 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 | 12 weeks |
| Forced Expiratory Volume in 1 second (FEV1) | Pulmonary function | 12 weeks |
| Forced Expiratory Volume in 1 second as a percentage of predicted value (FEV1 (%)) | Pulmonary function | 12 weeks |
| ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage (FEV1/FVC (%)) | Pulmonary function | 12 weeks |
| Peak Expiratory Flow (PEF (L/min)) | Pulmonary function | 12 weeks |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |