The effect of acidosis correction and exercise on tissue wasting and immune function in renal patients

Phase 1

• Conditions: Chronic kidney disease

• Registration Number: EUCTR2006-006948-65-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-26
• Study Completion: 2009-07-04
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Chronic kidney disease patients at CKD stages 4 to 5

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Physical disability sufficient to preclude participating in an exercise programme
Age less than 18 years
Pregnancy
Congestive heart failure
Live cirrhosis

The Summary of Product Characteristics also recommends caution in the use of sodium bicarbonate in those with impaired renal function , hypertension, and dietary sodium restriction. These features characterise all subjects recruited to this study. Due caution will be exercised based on the expert clinical knowledge and experience of the investigators.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The interaction between exercise and metabolic acidosis in chronic kidney disease has never been investigated. Important questions to be answered are:<br>•What influence does correcting acidosis have on exercise tolerance? <br>•Are the expected beneficial effects of exercise and acidosis correction additive?<br> OR<br>•Does exercise (which generates lactic acid in muscle) worsen the acidosis problem? This may be important in kidney patients because the level of exercise needed to generate lactic acid (the lactate threshold) is low. <br>•Does correcting acidosis allow an improved response to exercise in those kidney patients who currently respond poorly to exercise therapy alone? <br>;Secondary Objective: ;Primary end point(s): Muscle mass and ability to perform exercise<br>Signals in muscle which control protein synthesis<br>Blood pressure, pulse wave velocity, finometry<br>Quality of life using Leicester uraemic symptoms score<br>