Effect of Exercise and Protein Supplementation on Muscle Function in Patients With Hemodialysis
- Conditions
- Sarcopenia
- Interventions
- Other: exercise and nutritional support
- Registration Number
- NCT04927208
- Lead Sponsor
- Chungnam National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- Patients with hemodialysis
- Community-dwellers
- Able to walk with or without assistive devices for more than 100 meters
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Improved skeletal muscle function due to protein supplementation exercise and nutritional support Experimental: Intervention group Improved skeletal muscle function due to protein supplementation
- Primary Outcome Measures
Name Time Method Handgrip strength in Kg 24weeks Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle.
- Secondary Outcome Measures
Name Time Method The total score of SPPB(Short Physical Performance Battery) 24 weeks The 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 Test 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.
skeletal muscle mass index in cm2/m2 24 weeks The SMI was calculated according to the following formula: skeletal muscle mass (cm 2) / height 2 (m 2).
Trial Locations
- Locations (1)
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of