Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04927208
Enrollment
22
Registered
2021-06-15
Start date
2021-01-27
Completion date
2021-09-09
Last updated
2021-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

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.

Interventions

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

Sponsors

Chungnam National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Handgrip strength in Kg24weeksMeasurement of handle strength using a portable dynamometer to view the function of skeletal muscle.

Secondary

MeasureTime frameDescription
The total score of SPPB(Short Physical Performance Battery)24 weeksThe 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 Test24 weeksPre 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/m224 weeksThe SMI was calculated according to the following formula: skeletal muscle mass (cm 2) / height 2 (m 2).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026