Dialysis patients
Conditions
Interventions
Intervention: 12-week carnitine supplementation in addition to exercise therapy Exercise training includes 3-5 minutes of stretching followed by 10-30 minutes of aerobic exercise, plus 3-5 minutes
s condition.
Control: 12-week exercise therapy only Exercise therapy will be the same as in the intervention group.
Sponsors
International University of Health and Welfare Narita Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Dialysis outpatients with carnitine deficiency or high risk of carnitine deficiency (free carnitine [FC] < 36 micromol/L) and/or carnitine insufficiency (acylcarnitine [AC]/FC > 0.40) 2) Patients from whom written informed consent was obtained
Exclusion criteria
Exclusion criteria: 1) Patients who are contraindicated for exercise training. Concrete criteria are as follows: patients with uncontrolled persistent hypertension (systolic blood pressure >= 180 mmHg or diastolic pressure >= 110 mmHg); severe anemia (Hb < 7 g/dL); active proliferative diabetic retinopathy; prior symptomatic coronary artery or cerebrovascular diseases within the previous 3 months; uncontrolled heart failure (NYHA >= III); symptomatic or lethal arrhythmia; severe valvular diseases; and walking difficulty due to orthopedic, cerebrovascular and peripheral artery diseases. 2) Unstable dialysis patients. Concrete criteria are as follows: patients who undergo dialysis less than 3 months and those with uncontrolled uremia (BUN > 100 mg/dL, K > 6.0 mEq/L and HCO3 < 18 mmoL/L). 3) Patients deemed inadequate for monitoring during study period, as determined by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VO2peak (peak oxygen uptake) assessed by cardiopulmonary test, evaluated 12 weeks after the assignment | — |
Secondary
| Measure | Time frame |
|---|---|
| The following parameters at 12 weeks after the assignment: VE/VCO2 slope, WR (work rate), AT (anaerobic threshold), and CI (chronotropic index) assessed by cardiopulmonary test Various physical activity levels (including adherence to home exercise therapy) assessed by iAide2 Body composition (including skeletal mass index [SMI]) as assessed by InBody Specific clinical parameters (nutritional status, anemia, carnitine profile, biomarkers of cardiac function, etc.) | — |
Countries
Japan
Contacts
Public ContactKiyotaka Uchiyama
International University of Health and Welfare Narita Hospital Department of Nephrology
Outcome results
None listed