COPD Clinical Trial
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 31, 2032 |
Est. primary completion date | October 31, 2032 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taichung Veterans General Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
Orient Europharma Co., Ltd. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of physical performance (Grip strength) | Grip strength (kg) Instrument: Smedley dynamometer | 12 weeks | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Change of body composition: BMI(kg/m^2) | 12 weeks | ||
Primary | Change of body composition: SMI (kg/m^2) | PBF (%), ASM (kg), LMM (kg), BMD (T-score), RASM (kg/m^2) | 12 weeks | |
Primary | PBF (%) | Change of body composition | 12 weeks | |
Primary | ASM (kg) | Change of body composition | 12 weeks | |
Primary | LMM (kg) | Change of body composition | 12 weeks | |
Primary | BMD (T-score) | Change of body composition | 12 weeks | |
Primary | RASM (kg/m^2) | Change of body composition | 12 weeks | |
Primary | Forced Expiratory Volume in 1 second(FEV1(L)) | Change of lung function | 12 weeks | |
Primary | Forced Expiratory Volume in 1 second as a percentage of predicted value(FEV1 (%)) | Change of lung function | 12 weeks | |
Primary | ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage(FEV1/FVC (%)) | Change of lung function | 12 weeks | |
Primary | Peak Expiratory Flow(PEF (L/min)) | Change of lung function | 12 weeks | |
Primary | RBC (/µL) | Complete blood count | 12 weeks | |
Primary | WBC (/µL) | Complete blood count | 12 weeks | |
Primary | PLT (/µL) | Complete blood count | 12 weeks | |
Primary | Hb | Complete blood count | 12 weeks | |
Primary | Hematocrit | Complete blood count | 12 weeks | |
Primary | TG | Hepatic function | 12 weeks | |
Primary | SGOT (U/L) | Hepatic function | 12 weeks | |
Primary | SGPT (U/L) | Hepatic function | 12 weeks | |
Primary | Total cholesterol(mg/dL) | Hepatic function | 12 weeks | |
Primary | LDL-C (mg/dL) | LDL-C (mg/dL) | 12 weeks | |
Primary | Fasting glucose (mg/dL) | Fasting glucose (mg/dL) | 12 weeks | |
Primary | HbA1c (%) | HbA1c (%) | 12 weeks | |
Primary | Total protein (g/dL) | Total protein (g/dL) | 12 weeks | |
Primary | Albumin (g/dL) | Albumin (g/dL) | 12 weeks | |
Primary | Renal function | BUN?CREAT(mg/dL) | 12 weeks | |
Primary | Hs-CRP | Hs-CRP | 12 weeks | |
Primary | Vitamin D | Vitamin D | 12 weeks | |
Secondary | SARC-Calf questionnaire | compare the effect of the same intervention on Sarcopenia and different severity of Sarcopenia. | 12 weeks | |
Secondary | Grip strength test | compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia. | 12 weeks | |
Secondary | Sit-stand test | compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia. | 12 weeks | |
Secondary | Short physical performance battery (SPPB) | compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia. | 12 weeks | |
Secondary | Gait speed test | compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia. | 12 weeks | |
Secondary | Six-minute walk test. | compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia. | 12 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Forced Expiratory Volume in 1 second (FEV1) | Pulmonary function | 12 weeks | |
Secondary | Forced Expiratory Volume in 1 second as a percentage of predicted value (FEV1 (%)) | Pulmonary function | 12 weeks | |
Secondary | ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage (FEV1/FVC (%)) | Pulmonary function | 12 weeks | |
Secondary | Peak Expiratory Flow (PEF (L/min)) | Pulmonary function | 12 weeks |
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