Effects of the nutritional supplementation in combination with exercise therapy for hemodialysis patients complicated with sarcopenia: a randomized parallel-group pilot study
- Conditions
- Hemodialysis patients complicated with sarcopenia
- Registration Number
- JPRN-UMIN000025214
- Lead Sponsor
- Department of Nephrology, Kyoto Katsura Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Not provided
Persons, met any of the following criteria were excluded. 1. Patients not ensured of an adequate dialysis(below 1.2 in single-pool Kt/Vurea) 2. Patients with cardiovascular disease such as heart failure likely worsening within one week, unstable angina pectoris, myocardial ischemia induced with a low threshold value by slow walking on the level ground(2METS), a candidate for surgery of severe valvular disease, and exercise-induced arrhythmias 3. Patients with an acute systemic disease or fever 4. Patients with complicated severe hypertension, over 180mmHg systolic blood pressure or 100mmHg in diastolic blood pressure 5. Patients having complications with type 1 diabetes, poorly controlled type 2 diabetes and diabetic retinopathy 6. Patients having complication with severe liver disease 7. Patients having an allergy to milk and soy 8. Patients having complication with mental illness causing a communication difficulty 9. patients having a cardiac pacemaker implantation 10. Patients having a history of hospitalization less than one month before the enrollment 11. Additionally, patients, whose principal researcher determined unfit as a subject for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method An amount change of the fat free mass
- Secondary Outcome Measures
Name Time Method 1. the value change of the skeletal muscle index, lower limb muscle mass, skeletal muscle mass, body cell mass, phase angle and body fat percentage 2. the amount change of the grip strength and knee extension strength 3. the value change of Short Physical Performance Battery(SPPB) 4. the value change of the Geriatric Nutrition Risk Index(GNRI) and Malnutrition-Inflammation Score(MIS) 5. the variation change in the biochemical parameters 6. the value change of the single-pool Kt/Vurea, normalized protein catabolic rate(nPCR) and the creatinine generation rate % (%CGR) 7. the incidence ratio of adverse events