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

ConditionSarcopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChungnam National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with hemodialysis

Community-dwellers

Able to walk with or without assistive devices for more than 100 meters

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • exercise and nutritional support

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Improved skeletal muscle function due to protein supplementation and exerciseExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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.

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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).

Time frame
12 weeks
4

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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