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

Primary Purpose

Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
exercise and nutritional support
Sponsored by
Chungnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring hemodialysis, nutrition, exercise

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chungnam National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Improved skeletal muscle function due to protein supplementation and exercise

control

Arm Description

resistance exercise and protein supplementation including branched chain amino acids for 12 weeks

No intervention, but the same measurements as the experimental group are conducted.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
May 18, 2023
Last Updated
August 29, 2023
Sponsor
Chungnam National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05884138
Brief Title
Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chungnam National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
hemodialysis, nutrition, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Improved skeletal muscle function due to protein supplementation and exercise
Arm Type
Experimental
Arm Description
resistance exercise and protein supplementation including branched chain amino acids for 12 weeks
Arm Title
control
Arm Type
No Intervention
Arm Description
No intervention, but the same measurements as the experimental group are conducted.
Intervention Type
Other
Intervention Name(s)
exercise and nutritional support
Intervention Description
resistance exercise and protein supplementation including branched chain amino acids for 12 weeks
Primary Outcome Measure Information:
Title
Handgrip strength in Kg using a portable dyanometer
Description
Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle every 4 weeks.
Time Frame
12 weeks
Title
Body composition using dual energy x-ray absorptiometry (DXA)
Description
Body composition will be evaluated by dual energy x-ray absorptiometry at start and end of the study.
Time Frame
12 weeks
Title
Body composition using body composition monitor (BCM)
Description
Body composition will be evaluated by bioimpedence analysis using body composition monitor start at and end of the study.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The total score of Short Physical Performance Battery(SPPB)
Description
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.
Time Frame
12 weeks
Title
The second of 5 times Chair Stand Test
Description
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.
Time Frame
12 weeks
Title
skeletal muscle mass index(SMI) in cm2/m2
Description
The SMI was calculated according to the following formula: skeletal muscle mass (cm 2) / height 2 (m 2).
Time Frame
12 weeks
Title
Glucose pattern using continuous glucose monitoring system(freestyle libre)
Description
Blood glucose is measured using continuous glucose monitoring system(freestyle libre) at start and end of the study.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyon-Seung Yi
Phone
82-10-2411-9766
Email
jmpbooks00@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyon-Seung Yi
Organizational Affiliation
Chungnam National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyon-Seung Yi
Phone
+82-10-2411-9766
Email
jmpbooks00@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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