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ENROLLING BY INVITATION
NCT06910475
NA

Physical Exercise and Biomolecular Analysis to Reduce Uremic Toxins in Chronic Kidney Disease: An Exploratory Study

Sponsor: Catholic University of Brasília

View on ClinicalTrials.gov

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 ancestry in Brazilians, given the country's ethnic diversity, resulting in inaccurate estimates. On the other hand, physical exercise is an important ally in treating chronic kidney disease (CKD) as it induces metabolic changes that help slow the disease's progression. Additionally, the anti-aging effect conferred on those who engage in physical exercise is widely recognized. However, investigations into the impact of physical exercise on the concentration of uremic toxins and biological aging in patients with chronic kidney disease and their relationship with ancestry are still in the early stages and inconclusive. The investigators aim to track uremic toxins, exerkines, genetic aspects, nutritional profile, physical fitness, body composition, and the effects of different types of physical training (periodized and progressive) in people with chronic kidney disease at various stages. Additionally, to verify associations between these factors and their effects on different physiological systems. This is a triple-blind randomized clinical trial, with a 10-year follow-up of patients. The sampling will be non-probabilistic in terms of accessibility or convenience. Adult volunteers of both biological sexes aged 18 or older, with chronic kidney disease in conservative treatment (stages 2, 3, 4, and 5, n\~400), patients undergoing renal replacement therapy (hemodialysis or peritoneal dialysis, n\~800), and transplant recipients (n\~400) will be recruited from different hemodialysis centers. After being grouped by disease stage, patients will be randomized according to pre-training variables and then allocated to the following groups: control group (CTL; at least n\~100), strength training (ST; at least n\~100), aerobic training (AT; at least n\~100), and combined training (CT; at least n\~100). The patients will undergo evaluations of body composition, cardiorespiratory capacity, muscle strength, autonomic nervous system function, and nutritional, psychological, and biomolecular assessments. The training protocols will be adjusted according to the patient's physical capacity, always considering periodization and progression.

Official title: Exerkidney: A Tracking of Uremic Toxins, Exerkines, Genetic Aspects, Physical Fitness, Body Composition, and The Effects of Physical Training in People With Chronic Kidney Disease at Different Stages

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1600

Start Date

2025-04-01

Completion Date

2035-12-31

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

OTHER

Resistance training

The training program will follow a periodized approach, starting with a low total volume (loads x sets x repetitions), ensuring gradual adaptation, patient safety, and performance progression. Strength training will begin 48 hours after muscle strength tests.Sessions will occur 2 to 4 times per week on non-consecutive days. Each session will include 6-12 exercises, with 1-3 seconds for concentric and eccentric actions, 6-20 repetitions, 1-6 sets, and 1-3 minutes of rest. Intensity will be gauged by perceived exertion, ranging from "easy" to "hard," with load adjustments every 2 months based on progress.Patients undergoing hemodialysis may perform the sessions during or between treatments. Portable equipment like free weights, ankle weights, and resistance bands will be used.

OTHER

Endurance training

Training sessions will be conducted 2 to 4 times per week on non-consecutive days. Patients will perform aerobic training on different ergometers, namely: bicycle, treadmill, and stair climber. The choice will depend on the patient's needs/abilities and/or equipment availability. The load will be adjusted between 50% and 100% of the ventilatory threshold, according to the patient's cardiorespiratory capacity. The duration of the training will vary between 10 and 60 minutes, always starting with low load and volume, with gradual progression to ensure patient comfort and safety.

OTHER

Concurrent training

Training sessions will be conducted 2 to 6 times per week, alternating between strength training one day and aerobic training the next, as described above. As patients improve their physical fitness, strength and aerobic training may be performed on the same day.

Locations (1)

Catholic University of Brasília

Taguatinga, Federal District, Brazil