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NCT Number: NCT04927208

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chungnam National University Hospital

Daejeon, 35015, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exercise and nutritional support

Other

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

Primary outcomes

  1. Handgrip strength in Kg

    Time frame: 24weeks

    Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle.

Secondary outcomes

  1. The total score of SPPB(Short Physical Performance Battery)

    Time frame: 24 weeks

    The total score is the sum of 5 times CST score and balance test score and gait speed test score for 4meter.

  2. The second of 5 times Chair Stand Test

    Time frame: 24 weeks

    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.

  3. skeletal muscle mass index in cm2/m2

    Time frame: 24 weeks

    The SMI was calculated according to the following formula: skeletal muscle mass (cm 2) / height 2 (m 2).

Sponsors and collaborators

Lead sponsor

Chungnam National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2021
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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