Effect of Exercise and Protein Supplementation on Muscle Function in Patients With Hemodialysis
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
exercise and nutritional support
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
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.
Sites / Locations
- Chungnam National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Improved skeletal muscle function due to protein supplementation
Arm Description
Experimental: Intervention group Improved skeletal muscle function due to protein supplementation
Outcomes
Primary Outcome Measures
Handgrip strength in Kg
Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle.
Secondary Outcome Measures
The total score of SPPB(Short Physical Performance Battery)
The total score is the sum of 5 times 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 in cm2/m2
The SMI was calculated according to the following formula: skeletal muscle mass (cm 2) / height 2 (m 2).
Full Information
NCT ID
NCT04927208
First Posted
May 17, 2021
Last Updated
December 28, 2021
Sponsor
Chungnam National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04927208
Brief Title
Effect of Exercise and Protein Supplementation on Muscle Function in Patients With Hemodialysis
Official Title
Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
September 9, 2021 (Actual)
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. Here, The investigators aim a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for sarcopenia in patients with hemodialysis.
This is a prospective study with 60 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, 12, and 24 weeks after intervention. The data will be analysed using the intention-to-treat principle.
Detailed Description
While feasible, inexpensive, and non radiation-exposed tools such as bioimpedance analysis have been used to measure appendicular skeletal muscle mass. In addition, isokinetic strength will be measured by a dynamometer for hand grip strength to evaluate sarcopenia. The main two axes of treatment of conventional sarcopenia are muscle resistance exercises and protein supplementation including branched chain amino acids. Therefore, it is necessary to confirm the clinical effect by intervention for resistance exercise and nutritional supplementation in patients with hemodialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Improved skeletal muscle function due to protein supplementation
Arm Type
Experimental
Arm Description
Experimental: Intervention group Improved skeletal muscle function due to protein supplementation
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
Other: Combined exercise and nutrition intervention resistance exercise and nutritional supplementation for 12 weeks
Primary Outcome Measure Information:
Title
Handgrip strength in Kg
Description
Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle.
Time Frame
24weeks
Secondary Outcome Measure Information:
Title
The total score of SPPB(Short Physical Performance Battery)
Description
The total score is the sum of 5 times CST score and balance test score and gait speed test score for 4meter.
Time Frame
24 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
24 weeks
Title
skeletal muscle mass index in cm2/m2
Description
The SMI was calculated according to the following formula: skeletal muscle mass (cm 2) / height 2 (m 2).
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Exercise and Protein Supplementation on Muscle Function in Patients With Hemodialysis
We'll reach out to this number within 24 hrs