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

NCT04927208 | Completed

• 1 other identifier: CNUH-ED-2021-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Handgrip strength in Kg

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

  24weeks

Secondary Outcomes (3)

• The total score of SPPB(Short Physical Performance Battery)

  24 weeks

• The second of 5 times Chair Stand Test

  24 weeks

• skeletal muscle mass index in cm2/m2

  24 weeks

Study Arms (1)

Improved skeletal muscle function due to protein supplementation

EXPERIMENTAL

Experimental: Intervention group Improved skeletal muscle function due to protein supplementation

Other: exercise and nutritional support

Interventions

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

Improved skeletal muscle function due to protein supplementation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hemodialysis
• Community-dwellers
• Able to walk with or without assistive devices for more than 100 meters

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chungnam National University Hospital: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Related Publications (1)

• Ju SH, Lee EJ, Sim BC, Nga HT, Lee HY, Tian J, Cho KJ, Park H, Choi DE, Ham YR, Yi HS. Leucine-enriched amino acid supplementation and exercise to prevent sarcopenia in patients on hemodialysis: a single-arm pilot study. Front Nutr. 2023 Apr 28;10:1069651. doi: 10.3389/fnut.2023.1069651. eCollection 2023.

  PMID: 37187878 DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise; Nutritional Support

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: June 15, 2021
• Study Start: January 27, 2021
• Primary Completion: April 1, 2021
• Study Completion: September 9, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-05

Locations

KR (1)