Status:
NOT_YET_RECRUITING
Physical Exercise and Biomolecular Analysis to Reduce Uremic Toxins in Chronic Kidney Disease: An Exploratory Study
Lead Sponsor:
Catholic University of Brasília
Conditions:
Kidney Disease, Chronic
Kidney Failure Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The accumulation of uremic toxins is detrimental to physiological systems and induces premature biological aging. Renal function assessment methods, such as predictive formulas, may be influenced by a...
Detailed Description
This study is a randomized, triple-blind clinical trial with a 10-year follow-up. Sampling is non-probabilistic by accessibility or convenience. Recruitment: Recruitment will be widely promoted via ma...
Eligibility Criteria
Inclusion
- those diagnosed with chronic kidney disease and presenting persistent albuminuria (\>300mg/g) following KDIGO guidelines;
- metabolic syndrome {i.e., type 2 diabetes mellitus, arterial hypertension (blood pressure \>180/100mmHg), overweight or obesity, and dyslipidemia};
- no complications arising from pre-existing clinical metabolic diseases (i.e., diabetic coma, ketoacidosis, hyperosmolarity, and/or uncontrolled diabetes), as evaluated by a nephrologist;
- absence of neurodegenerative, musculoskeletal, lupus erythematosus, or congenital kidney disease;
- no apparent cardiovascular complications, such as heart failure, severe arrhythmia, angina, or cerebrovascular disease;
- no comorbidities that limit performance in physical tests or training;
- not engaged in exercise programs for at least six months prior to the start of the experimental protocol;
- no smoking or alcohol consumption behavior;
- D-dimer values within normal range (220-500 ng/mL FEU)
Exclusion
- regularly engage in physical exercise,
- have suffered a stroke in the last 6 months and/or present autoimmune diseases,
- have unstable cardiac dysfunctions, such as: uncontrolled coronary artery disease, aneurysm at risk of rupture, uncontrolled arrhythmia, uncontrolled hypertension (SBP \> 190 mmHg and/or DBP \> 100 mmHg), heart attack in the last 3 months;
- infectious conditions, Hb \< 8 in the last routine monthly hemodialysis exam;
- musculoskeletal pain;
- fever;
- resting SpO2 lower than 94%;
- restriction by the clinical team.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2035
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT06910475
Start Date
April 1 2025
End Date
December 31 2035
Last Update
April 4 2025
Active Locations (1)
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1
Catholic University of Brasília
Taguatinga, Federal District, Brazil, 71966-700