Evaluate the Effect of Dietary Supplement Combined Exercise Among Patients With Sarcopenia Comorbid With Lung Disease
- Conditions
- SarcopeniaCOPDILD
- Interventions
- Dietary Supplement: Sarcojoint®Behavioral: supervised exercise
- Registration Number
- NCT05926713
- Lead Sponsor
- Orient Europharma Co., Ltd.
- Brief 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.
- 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
1. Baseline demographic characteristic, health behavior and exercise habits are collected by questionnaires.
2. The main disease diagnosis, medication, clinical assessment questionnaire or biochemical examination and radiological examination results are collected.
3. 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.
4. 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.
5. 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.
6. All participants are required to walk 6500 steps every day for 12 weeks, and the data are recorded by Xiaomi-smart-band.
7. 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.
8. 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.
9. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description nutritional supplements and supervised exercise on Sarcopenia group and Severe Sarcopenia group supervised exercise 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. nutritional supplements and supervised exercise on Sarcopenia group and Severe Sarcopenia group Sarcojoint® 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.
- Primary Outcome Measures
Name Time Method Total cholesterol(mg/dL) 12 weeks Hepatic function
LDL-C (mg/dL) 12 weeks LDL-C (mg/dL)
Change of body composition: BMI(kg/m^2) 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. 12 weeks SpO2%, HR, Borg score, times and second
Change of physical performance (Grip strength) 12 weeks Grip strength (kg) Instrument: Smedley dynamometer
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: SMI (kg/m^2) 12 weeks PBF (%), ASM (kg), LMM (kg), BMD (T-score), RASM (kg/m\^2)
BMD (T-score) 12 weeks Change of body composition
ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage(FEV1/FVC (%)) 12 weeks Change of lung function
RBC (/μL) 12 weeks Complete blood count
Hb 12 weeks Complete blood count
SGPT (U/L) 12 weeks Hepatic function
Fasting glucose (mg/dL) 12 weeks Fasting glucose (mg/dL)
HbA1c (%) 12 weeks HbA1c (%)
Total protein (g/dL) 12 weeks Total protein (g/dL)
ASM (kg) 12 weeks Change of body composition
LMM (kg) 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
Peak Expiratory Flow(PEF (L/min)) 12 weeks Change of lung function
WBC (/μL) 12 weeks Complete blood count
Hematocrit 12 weeks Complete blood count
TG 12 weeks Hepatic function
SGOT (U/L) 12 weeks Hepatic function
Renal function 12 weeks BUN、CREAT(mg/dL)
Albumin (g/dL) 12 weeks Albumin (g/dL)
Hs-CRP 12 weeks Hs-CRP
Vitamin D 12 weeks Vitamin D
PBF (%) 12 weeks Change of body composition
PLT (/μL) 12 weeks Complete blood count
- Secondary Outcome Measures
Name Time Method Six-minute walk test. 12 weeks compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.
Grip strength test 12 weeks compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.
SMI (kg/m^2) 12 weeks 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
SARC-Calf questionnaire 12 weeks compare the effect of the same intervention on Sarcopenia and different severity of Sarcopenia.
Bioelectrical impedance analysis (BIA) 12 weeks compare the effect of the same intervention on Sarcopenia and different severity of Sarcopenia on the outcome of body composition
Forced Expiratory Volume in 1 second (FEV1) 12 weeks Pulmonary function
Peak Expiratory Flow (PEF (L/min)) 12 weeks Pulmonary function
Short physical performance battery (SPPB) 12 weeks compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.
Sit-stand test 12 weeks compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.
Gait speed test 12 weeks compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.
Forced Expiratory Volume in 1 second as a percentage of predicted value (FEV1 (%)) 12 weeks Pulmonary function
ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage (FEV1/FVC (%)) 12 weeks Pulmonary function
Trial Locations
- Locations (1)
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan