CKD stage 3b and CKD stage 4 at risk of PEW CKD stage 3b, CKD stage 4, at risk of PEW, muscle strength, physical performance, quality of life, resistance exercise, low protein diet, home-based resistance exercise, oral nutritional support, ONS
Conditions
Interventions
Standard of care (low protein diet)
For patients with CKD stage 3b-4, the standard of care is a low-protein diet (LPD) to slow the progression of kidney function decline. The dietary targets are tota
Experimental Dietary Supplement,Active Comparator Other,Active Comparator Other
Low protein diet with oral nutritional support,Low protein diet with resistance exercise,Low protein diet with resistance exercise with oral nutritional support
Sponsors
R2R siriraj
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age 18 to 65 years, 2.Chronic kidney disease (CKD) stage 3b and 4 according to the KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of CKD, 3. At risk of protein-energy wasting (PEW) as defined by the ISRNM 2008 criteria (presence of at least two of the four diagnostic categories)
Exclusion criteria
Exclusion criteria: 1. Serum albumin < 3 g/dL or BMI < 16 kg/m2 2. Uncontrolled hypertension (SBP > 180 and/or DBP > 110 mmHg) 3. Severe anemia (Hb level < 7 mg/dL) 4. Musculoskeletal problems that prevent participants from practicing exercise 5. Cardiovascular disease or respiratory diseases that prevented participants from practicing exercise 6. Instability (unable to maintain balance and stability while sitting, walking, or standing) 7. Recent illness within 3 months 8. Active malignancy 9. Persons with visual impairments, hearing or intellectual disabilities, or unable to communication 10. Pregnancy 11. Allergy to riceberry 12. Unable to walk without gait aids 13. Use of or presence of implanted electronic or magnetically sensitive medical devices (e.g., pacemaker, ICD, deep brain stimulator, cochlear implant, or other similar devices) that may be affected by study procedures 14. SpO2 at rest < 95%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle strength at 12 weeks after end of the intervention Hand-grip and Back-leg dynamometer,Physical performance at 12 weeks after end of the intervention 6-minute walk test (6MWT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood chemistry at 12 weeks after end of the intervention Serum albumin, Serum prealbumin, Total cholesterol, LDL, Triglyceride, Serum BUN, Cr electrolytes, Ca, PO4, iPTH, FBG, HbA1C,Nutritional outcome at 12 weeks after end of the intervention 3-day food record form assessed by dietitians and calculating total calories, fat, protein intake, nPNA,Health-related quality of life at 12 weeks after end of the intervention KDQOL-SF1.3 (Thai version),Body composition at 12 weeks after end of the intervention Bioelectrical impedance,Inflammatory markers at 12 weeks after end of the intervention CRP measurement | — |
Countries
Thailand
Contacts
Public ContactKraiwiporn Kiattisunthorn
Siriraj hospital
Outcome results
None listed