Clinical trial NCT05884138: Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients
Official title: A Randomized Controlled Trial to Analyze the Effects of Essential Aminoacid Supplementation and Exercise on the Improvement of Skeletal Muscle Function in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Keywords: hemodialysis
nutrition
exercise
Lead sponsor: Chungnam National University Hospital
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Detailed description: This is a prospective, 1:1 randomized controlled study with 40 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, 4, 8 and 12 weeks after intervention. The data will be analysed using the intention-to-treat principle.

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.

Primary outcomes:
measure: Handgrip strength in Kg using a portable dyanometer
timeFrame: 12 weeks
measure: Body composition using dual energy x-ray absorptiometry (DXA)
timeFrame: 12 weeks
measure: Body composition using body composition monitor (BCM)
timeFrame: 12 weeks
Secondary outcomes:
measure: The total score of Short Physical Performance Battery(SPPB)
timeFrame: 12 weeks
measure: The second of 5 times Chair Stand Test
timeFrame: 12 weeks
measure: skeletal muscle mass index(SMI) in cm2/m2
timeFrame: 12 weeks
measure: Glucose pattern using continuous glucose monitoring system(freestyle libre)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Chungnam National University Hospital
name: Hyon-Seung Yi
role: STUDY_CHAIR
References: