Evaluate the Effect of Dietary Supplement Combined Exercise Among Patients With Sarcopenia Comorbid With Lung Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

supervised exercise: All participants are required to walk 6500 steps every day for 12 weeks, and the data are recorded by Xiaomi-smart-band.

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Change of physical performance (Grip strength) — 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. — 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 — 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) — 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. ) — 12 weeks
  SpO2%, HR, Borg score, and the walking distance
• Change of body composition: BMI(kg/m^2) — 12 weeks
• Change of body composition: SMI (kg/m^2) — 12 weeks
  PBF (%), ASM (kg), LMM (kg), BMD (T-score), RASM (kg/m\^2)
• PBF (%) — 12 weeks
  Change of body composition
• ASM (kg) — 12 weeks
  Change of body composition
• LMM (kg) — 12 weeks
  Change of body composition
• BMD (T-score) — 12 weeks
  Change of body composition
• RASM (kg/m^2) — 12 weeks
  Change of body composition
• Forced Expiratory Volume in 1 second(FEV1(L)) — 12 weeks
  Change of lung function
• Forced Expiratory Volume in 1 second as a percentage of predicted value(FEV1 (%)) — 12 weeks
  Change of lung function
• ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage(FEV1/FVC (%)) — 12 weeks
  Change of lung function
• Peak Expiratory Flow(PEF (L/min)) — 12 weeks
  Change of lung function
• RBC (/μL) — 12 weeks
  Complete blood count
• WBC (/μL) — 12 weeks
  Complete blood count
• PLT (/μL) — 12 weeks
  Complete blood count
• Hb — 12 weeks
  Complete blood count
• Hematocrit — 12 weeks
  Complete blood count
• TG — 12 weeks
  Hepatic function
• SGOT (U/L) — 12 weeks
  Hepatic function
• SGPT (U/L) — 12 weeks
  Hepatic function
• Total cholesterol(mg/dL) — 12 weeks
  Hepatic function
• LDL-C (mg/dL) — 12 weeks
  LDL-C (mg/dL)
• Fasting glucose (mg/dL) — 12 weeks
  Fasting glucose (mg/dL)
• HbA1c (%) — 12 weeks
  HbA1c (%)
• Total protein (g/dL) — 12 weeks
  Total protein (g/dL)
• Albumin (g/dL) — 12 weeks
  Albumin (g/dL)
• Renal function — 12 weeks
  BUN、CREAT(mg/dL)
• Hs-CRP — 12 weeks
  Hs-CRP
• Vitamin D — 12 weeks
  Vitamin D

Trial sites (1)

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