Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04375553 |
| Other study ID # |
Denise Mafra 5 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2017 |
| Est. completion date |
December 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Universidade Federal Fluminense |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Patients with chronic kidney disease (CKD), especially those who are on dialysis, have a high
prevalence of cardiovascular mortality and among the risk factors; inflammation and oxidative
stress stand out. Furthermore, recently this scenario, beyond those alterations found in
these patients, it has been suggested that the imbalance gut microbiota might be a new factor
of cardiovascular risk. Some treatment strategies have been studied in order to modulate the
gut microbiota and inflammation, such as the implementation of exercise programs. However,
the effects of exercise on the modulation of the gut microflora and inflammation have not
been evaluated in these patients. The aim of this project is to investigate possible changes
in gut microbiota, levels of uremic toxins and inflammatory and cardiovascular markers in CKD
patients on hemodialysis, after application of a training program with aerobic exercise.
Description:
Chronic kidney disease (CKD) patients on hemodialysis (HD) patients present reduced
functional capacity to approximately 50% and uremic myopathy and disuse atrophy have a
significant impact on the functional capacity of these patients (Johansen, 1999; Parsons,
2006).
There are several physical exercise benefits for CKD patients, such as improved ability to
perform exercises, increase of strength, quality of life and improve the maximal oxygen
consumption (VO2MÁX), which contributes to the improvement of cardiovascular aspects
(Johansen, 2007; Johansen, 2005; Heiwe, 2014). In fact, CKD patients who practice regular
exercise have a higher survival rate (O'Hare et al., 2003).
In addition, some mechanisms regarding anti-inflammatory effects of the exercises has been
proposed, such as: reduction of visceral fat which decreases the secretion of
pro-inflammatory cytokines, increased production and release of anti-inflammatory cytokines
from muscle contraction and reduced expression of Toll-like receptors (TLRs) in monocytes and
macrophages, which decreases the pro-inflammatory response (Petersen & Pedersen, 2005;
Gleeson et al., 2006).
In parallel, during exercises like running or cycling, there is an increase in capillary
surface area, with opening of capillaries previously inactive, consequently increasing
exchange of substances between the blood and the tissues. Thus, physical exercise could
result in a greater flux of urea and associated toxins from tissue to vascular compartment,
improving the efficiency of dialysis (Parsons et al., 2006; Guyton E Hall, 2017). According
KDOQI (Kidney Disease Outcomes Quality Initiative), Kt/V, a measure of urea clearance, is the
most frequently applied measure of the delivered dialysis dose and reflects the dialyzer
effect on patient survival (KDOQI, 2015).
Despite results showing the benefits of exercise to CKD patients, they are poorly prescribed,
remaining a challenge in clinical practice and high rates of physical inactivity are observed
in these patients (Williams et al., 2014; Barcellos, 2018).
Some gaps still need to be filled regarding the not yet known effect of physical exercise on
a number of clinical factors, thus allowing more specific and objective recommendations
(Williams et al., 2014). In this context, the present study aims to verify the effects of
12-week supervised and individualized intradialytic bicycle ergometer exercise on the
adequacy of dialysis, inflammatory markers and functional capacity of HD patients.
