Hemodialysis patients complicated with sarcopenia
Conditions
Interventions
Exercise therapy with combination of nutritional supplementation: Dietary supplements such as energy of 276kcal, protein of 6.3g, branched-chain amino acid of 1.54g are taken in each day for 12 weeks
Sponsors
Department of Nephrology, Kyoto Katsura Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects were enrolled after meeting all the following criteria. 1. Patients have undergone hemodialysis or hemodiafiltration three times a week for more than three months 2. Out-patients 3. Patients, 18 years age or older at the time of submitting written informed consent 4. Patients, after receiving a sufficient explanation upon participation in this study, agreed the consent document in full understanding and with a free will were enrolled as a subject 5. Patients who were diagnosed sarcopenia and pre-sarcopenia in the standard of Asian Working Group for sarcopenia(AWGS)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An amount change of the fat free mass | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYasunori Suzuki
Kyoto Katsura Hospital Dialysis Center
Outcome results
None listed