Clinical trial NCT05926713: Evaluate the Effect of Dietary Supplement Combined Exercise Among Patients With Sarcopenia Comorbid With Lung Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
COPD
ILD
Lead sponsor: Orient Europharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change of physical performance (Grip strength)
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: Change of physical performance (SPPB): Sit to stand test, balance test and 4-meter walk test will be combined to report SPPB score
timeFrame: 12 weeks
measure: Change of physical performance :6-meter walk test (second)
timeFrame: 12 weeks
measure: 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. )
timeFrame: 12 weeks
measure: Change of body composition: BMI(kg/m^2)
timeFrame: 12 weeks
measure: Change of body composition: SMI (kg/m^2)
timeFrame: 12 weeks
measure: PBF (%)
timeFrame: 12 weeks
measure: ASM (kg)
timeFrame: 12 weeks
measure: LMM (kg)
timeFrame: 12 weeks
measure: BMD (T-score)
timeFrame: 12 weeks
measure: RASM (kg/m^2)
timeFrame: 12 weeks
measure: Forced Expiratory Volume in 1 second(FEV1(L))
timeFrame: 12 weeks
measure: Forced Expiratory Volume in 1 second as a percentage of predicted value(FEV1 (%))
timeFrame: 12 weeks
measure: ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage(FEV1/FVC (%))
timeFrame: 12 weeks
measure: Peak Expiratory Flow(PEF (L/min))
timeFrame: 12 weeks
measure: RBC (/μL)
timeFrame: 12 weeks
measure: WBC (/μL)
timeFrame: 12 weeks
measure: PLT (/μL)
timeFrame: 12 weeks
measure: Hb
timeFrame: 12 weeks
measure: Hematocrit
timeFrame: 12 weeks
measure: TG
timeFrame: 12 weeks
measure: SGOT (U/L)
timeFrame: 12 weeks
measure: SGPT (U/L)
timeFrame: 12 weeks
measure: Total cholesterol(mg/dL)
timeFrame: 12 weeks
measure: LDL-C (mg/dL)
timeFrame: 12 weeks
measure: Fasting glucose (mg/dL)
timeFrame: 12 weeks
measure: HbA1c (%)
timeFrame: 12 weeks
measure: Total protein (g/dL)
timeFrame: 12 weeks
measure: Albumin (g/dL)
timeFrame: 12 weeks
measure: Renal function
timeFrame: 12 weeks
measure: Hs-CRP
timeFrame: 12 weeks
measure: Vitamin D
timeFrame: 12 weeks
Secondary outcomes:
measure: SARC-Calf questionnaire
timeFrame: 12 weeks
measure: Grip strength test
timeFrame: 12 weeks
measure: Sit-stand test
timeFrame: 12 weeks
measure: Short physical performance battery (SPPB)
timeFrame: 12 weeks
measure: Gait speed test
timeFrame: 12 weeks
measure: Six-minute walk test.
timeFrame: 12 weeks
measure: Bioelectrical impedance analysis (BIA)
timeFrame: 12 weeks
measure: SMI (kg/m^2)
timeFrame: 12 weeks
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 12 weeks
measure: Forced Expiratory Volume in 1 second as a percentage of predicted value (FEV1 (%))
timeFrame: 12 weeks
measure: ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity as a percentage (FEV1/FVC (%))
timeFrame: 12 weeks
measure: Peak Expiratory Flow (PEF (L/min))
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Department of Chest Medicine of Taichung Veterans General
name: Pin-Kuei Fu
role: PRINCIPAL_INVESTIGATOR
References: