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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926713
• Other study ID #: OEP-Sarcojoint
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: October 31, 2032

Study information

• Verified date: June 2023
• Source: Orient Europharma Co., Ltd.
• Contact: Pin-Kuei Fu, PhD
• Phone: 04-23592525
• Email: yetquen[@]vghtc.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• 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)

Related Conditions & MeSH terms

• COPD
• ILD
• Sarcopenia

Intervention

Dietary Supplement:
• 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.

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

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Orient Europharma Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

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