Effect of Exercise and Protein Supplementation on Muscle Function in Patients With Hemodialysis

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Other: exercise and nutritional support

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Improved skeletal muscle function due to protein supplementation; Experimental: Intervention group Improved skeletal muscle function due to protein supplementation	Other: exercise and nutritional support; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength in Kg	Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle.	24weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks
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.	24 weeks
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).	24 weeks

Collaborators and Investigators

• Sponsor: Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): September 9, 2021

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: CNUH-ED-2021-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No