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

NCT05926713 | Recruiting

• 1 other identifier: OEP-Sarcojoint
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; COPD; ILD

Outcome Measures

Primary Outcomes (33)

• 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 Outcomes (12)

• SARC-Calf questionnaire

  12 weeks

• Grip strength test

  12 weeks

• Sit-stand test

  12 weeks

• Short physical performance battery (SPPB)

  12 weeks

• Gait speed test

  12 weeks

Study Arms (1)

nutritional supplements and supervised exercise on Sarcopenia group and Severe Sarcopenia group

EXPERIMENTAL

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®; Behavioral: supervised exercise

Interventions

Sarcojoint® DIETARY_SUPPLEMENT

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.

nutritional supplements and supervised exercise on Sarcopenia group and Severe Sarcopenia group

supervised exercise BEHAVIORAL

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

nutritional supplements and supervised exercise on Sarcopenia group and Severe Sarcopenia group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Orient Europharma Co., Ltd.: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Pin-Kuei Fu

  Department of Chest Medicine of Taichung Veterans General

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pin-Kuei Fu, PhD

CONTACT

04-23592525; yetquen@vghtc.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: July 3, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): October 31, 2032
• Study Completion (Estimated): October 31, 2032
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

TW (1)