Aerobic Exercise in Patients With CKD
Primary Purpose
Chronic Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Kidney Diseases
Eligibility Criteria
Inclusion Criteria:
- Sedentary men and women between the ages of 18 and 60;
- patients with hemodialysis only with vascular access arteriovenous fistula who have been in dialysis for more than 6 months
- patients with hemoglobin levels greater than 10 mg / dL.
Exclusion Criteria:
- Patients taking catabolizing drugs, vitamin supplements, antioxidants, probiotics, prebiotics, symbiotics and antibiotics;
- patients with autoimmune, infectious, cancer, AIDS,
- patients with clinically unstable diseases (AMI less than 1 year, unstable angina, atrial fibrillation, significant cardiac arrhythmia and acute disease in the last month)
- patients with frequent hypotension during dialysis
- patients with chronic obstructive pulmonary disease and glycemic lability;
- incapacitated to perform exercise (amputation without prosthesis);
- musculoskeletal pain at rest or with minimal physical activity,
- inability to sit or walk without assistance,
- dyspnoea at rest or at slight exertion (NYHA III and IV).
- impediment to completing the proposed exercise protocol (travel, imminent renal transplantation).
Sites / Locations
- Denise Mafra
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Exercise group
Non-exercise group
Arm Description
Intradialytic aerobic exercise, 3 times a week, for 12 weeks.
Without intradialytic aerobic exercise for 12 weeks.
Outcomes
Primary Outcome Measures
Inflammatory biomarkers
Get blood samples to evaluate changes in the expression of transcription factors (nuclear factor erythroid 2-related factor 2 and Nuclear Factor-kB) that modulate inflammation.
Uremic toxins
Evaluation of P-Cresyl Sulfate, Indoxyl Sulfate (IS), Indole 3-Acetic Acid, Trimethyl N-oxide (TMAO) and lipopolysaccharides (LPSs).
Secondary Outcome Measures
Full Information
NCT ID
NCT04375553
First Posted
April 25, 2019
Last Updated
January 4, 2022
Sponsor
Universidade Federal Fluminense
1. Study Identification
Unique Protocol Identification Number
NCT04375553
Brief Title
Aerobic Exercise in Patients With CKD
Official Title
Effects of a Program of Aerobic Exercise on the Profile of Intestinal Microbiota and Cardiovascular Markers in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Federal Fluminense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Active Comparator
Arm Description
Intradialytic aerobic exercise, 3 times a week, for 12 weeks.
Arm Title
Non-exercise group
Arm Type
No Intervention
Arm Description
Without intradialytic aerobic exercise for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
Intradialytic aerobic exercise
Primary Outcome Measure Information:
Title
Inflammatory biomarkers
Description
Get blood samples to evaluate changes in the expression of transcription factors (nuclear factor erythroid 2-related factor 2 and Nuclear Factor-kB) that modulate inflammation.
Time Frame
12 weeks
Title
Uremic toxins
Description
Evaluation of P-Cresyl Sulfate, Indoxyl Sulfate (IS), Indole 3-Acetic Acid, Trimethyl N-oxide (TMAO) and lipopolysaccharides (LPSs).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sedentary men and women between the ages of 18 and 60;
patients with hemodialysis only with vascular access arteriovenous fistula who have been in dialysis for more than 6 months
patients with hemoglobin levels greater than 10 mg / dL.
Exclusion Criteria:
Patients taking catabolizing drugs, vitamin supplements, antioxidants, probiotics, prebiotics, symbiotics and antibiotics;
patients with autoimmune, infectious, cancer, AIDS,
patients with clinically unstable diseases (AMI less than 1 year, unstable angina, atrial fibrillation, significant cardiac arrhythmia and acute disease in the last month)
patients with frequent hypotension during dialysis
patients with chronic obstructive pulmonary disease and glycemic lability;
incapacitated to perform exercise (amputation without prosthesis);
musculoskeletal pain at rest or with minimal physical activity,
inability to sit or walk without assistance,
dyspnoea at rest or at slight exertion (NYHA III and IV).
impediment to completing the proposed exercise protocol (travel, imminent renal transplantation).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Mafra, PhD
Organizational Affiliation
Federal university fluminense
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denise Mafra
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22260-050
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36152526
Citation
Brito JS, Reis D, Silva G, Fonseca L, Ribeiro M, Chermut T, Oliveira L, Borges NA, Ribeiro-Alves M, Mafra D. Bicycle ergometer exercise during hemodialysis and its impact on quality of life, aerobic fitness and dialysis adequacy: A pilot study. Complement Ther Clin Pract. 2022 Nov;49:101669. doi: 10.1016/j.ctcp.2022.101669. Epub 2022 Sep 17.
Results Reference
derived
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Aerobic Exercise in Patients With CKD
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