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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia; COPD; ILD
• Intervention / Treatment: Dietary supplement: Sarcojoint®; Behavioral: supervised exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pin-Kuei Fu, PhD; Phone Number: 6536 04-23592525; Email: yetquen@vghtc.gov.tw

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • Taichung Veterans General Hospital
    • Contact: Pin-Kuei Fu, PhD; Phone Number: 6536 04-23592525; Email: yetquen@vghtc.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: nutritional supplements and supervised exercise on Sarcopenia group and Severe Sarcopenia group; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Orient Europharma Co., Ltd.
• Investigators: Principal Investigator: Pin-Kuei Fu, Department of Chest Medicine of Taichung Veterans General

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): October 31, 2032
• Study Completion (Estimated): October 31, 2032

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: OEP-Sarcojoint

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No