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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927208
• Other study ID #: CNUH-ED-2021-001
• Status: Completed
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: September 9, 2021

Study information

• Verified date: May 2021
• Source: Chungnam National University Hospital
• Contact: n/a
• 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 9, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 Other: Combined exercise and nutrition intervention resistance exercise and nutritional supplementation 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	Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle.	24weeks
Secondary	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
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.	24 weeks
Secondary	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