Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients

Sarcopenia Clinical Trial

Official title:

A Randomized Controlled Trial to Analyze the Effects of Essential Aminoacid Supplementation and Exercise on the Improvement of Skeletal Muscle Function in Hemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884138
• Other study ID #: CNUH-ED-2023-001
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: May 2023
• Source: Chungnam National University Hospital
• Contact: Hyon-Seung Yi
• Phone: 82-10-2411-9766
• Email: jmpbooks00[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sarcopenia can be easily observed in patients with hemodialysis. However, there were few studies on the precise concept and diagnostic criteria for sarcopenia in patients with hemodialysis. The investigators have already recognized the sarcopenia-associated mortality and morbidity in patients with hemodialysis. However, intervention studies on hemodialysis patients with sarcopenia have not been conducted until now. In 2021, the investigators conducted a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for sarcopenia in patients with hemodialysis to confirm the effectiveness. This study is a follow-up study, conducted as a randomized controlled trial.

Description:

This is a prospective, 1:1 randomized controlled study with 40 patients with hemodialysis who were diagnosed as sarcopenia or frailty in our previous cohort study. Combined intervention will consist of resistance exercise and nutritional supplementation for 12 weeks. The primary outcome of this study is muscle mass and handgrip strength after 12 weeks' intervention. All functional outcomes will be measured at 0, 4, 8 and 12 weeks after intervention. The data will be analysed using the intention-to-treat principle.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 29, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with hemodialysis

• Community-dwellers

• Able to walk with or without assistive devices for more than 100 meters

Exclusion Criteria:

• A person with cancer disease.

• People with psychiatric symptoms.

• A person who has an absorption disorder or has a history of resection of the small intestine or colon

• Pregnant women

• A person treated for acute bacterial infections

• A person who is in a wheelchair due to inconvenience in walking.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• exercise and nutritional support
resistance exercise and protein supplementation including branched chain amino acids for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Chungnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Handgrip strength in Kg using a portable dyanometer	Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle every 4 weeks.	12 weeks
Primary	Body composition using dual energy x-ray absorptiometry (DXA)	Body composition will be evaluated by dual energy x-ray absorptiometry at start and end of the study.	12 weeks
Primary	Body composition using body composition monitor (BCM)	Body composition will be evaluated by bioimpedence analysis using body composition monitor start at and end of the study.	12 weeks
Secondary	The total score of Short Physical Performance Battery(SPPB)	The total score is the sum of 5 times Chair Stand Test(CST) score and balance test score and gait speed test score for 4meter.	12 weeks
Secondary	The second of 5 times Chair Stand Test	Pre test, participants fold their arms across their chest and try to stand up once from a chair. And Measures the time required to perform five rises from a chair to an upright position as fast as possible without the use of the arms.	12 weeks
Secondary	skeletal muscle mass index(SMI) in cm2/m2	The SMI was calculated according to the following formula: skeletal muscle mass (cm 2) / height 2 (m 2).	12 weeks
Secondary	Glucose pattern using continuous glucose monitoring system(freestyle libre)	Blood glucose is measured using continuous glucose monitoring system(freestyle libre) at start and end of the study.	12 weeks