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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorOrient Europharma Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: nutritional supplements and supervised exercise on Sarcopenia group and Severe Sarcopenia groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change of physical performance (Grip strength)

Grip strength (kg) Instrument: Smedley dynamometer

Time frame
12 weeks
2

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

Time frame
12 weeks
3

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

Time frame
12 weeks
4

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. )

Time frame
12 weeks

Secondary outcomes

1

SARC-Calf questionnaire

compare the effect of the same intervention on Sarcopenia and different severity of Sarcopenia.

Time frame
12 weeks
2

Grip strength test

compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.

Time frame
12 weeks
3

Sit-stand test

compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.

Time frame
12 weeks
4

Short physical performance battery (SPPB)

compare the outcome of physical performance of the same intervention on Sarcopenia and different severity of Sarcopenia.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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