Chronic Kidney DiseasesNCT04375553
Aerobic Exercise in Patients With CKD
A study testing Aerobic exercise in people with Chronic Kidney Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2017to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Program of Aerobic Exercise on the Profile of Intestinal Microbiota and Cardiovascular Markers in Patients With Chronic Kidney Disease
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Aerobic exercise
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Intradialytic aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Active comparator | Intradialytic aerobic exercise, 3 times a week, for 12 weeks. Receives: Other: Aerobic exercise |
| Non-exercise group | No intervention | Without intradialytic aerobic exercise for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Uremic toxins
Evaluation of P-Cresyl Sulfate, Indoxyl Sulfate (IS), Indole 3-Acetic Acid, Trimethyl N-oxide (TMAO) and lipopolysaccharides (LPSs).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study startJan 2017
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Mafra, PhD, Principal investigator, Federal university fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375553
- Sponsor's protocol ID
- Denise Mafra 5
- Status last verified
- Jan 2022
- First submitted
- 25 Apr 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brito JS, Borges NA, Reis DCMV, Silva GSD, Fonseca LDS, Ribeiro MMF, Chermut TR, Moura MC, Oliveira LC, Paiva BR, Cardozo LF, Capistrano ESM, Mafra D. Effects of intradialytic bicycle ergometer exercise on transcription factors NF-kB and Nrf2 in patients with chronic kidney disease: A randomized crossover clinical trial. J Bodyw Mov Ther. 2024 Oct;40:1492-1501. doi: 10.1016/j.jbmt.2024.08.003. Epub 2024 Aug 8.
PubMed 39593477Brito 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.
PubMed 36152526
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Program of Aerobic Exercise on the Profile of Intestinal Microbiota and Cardiovascular Markers in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04375553
- Acronym / sponsor ID
- Denise Mafra 5
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Active comparator | Other: Aerobic exerciseIntradialytic aerobic exercise, 3 times a week, for 12 weeks. |
| Non-exercise group | No intervention | –Without intradialytic aerobic exercise for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseIntradialytic aerobic exercise | Other | Exercise group |
Primary outcome
Inflammatory biomarkers
Time frame: 12 weeks
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
Time frame: 12 weeks
Evaluation of P-Cresyl Sulfate, Indoxyl Sulfate (IS), Indole 3-Acetic Acid, Trimethyl N-oxide (TMAO) and lipopolysaccharides (LPSs).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Derived from this study: PubMed 39593477Brito JS, Borges NA, Reis DCMV, Silva GSD, Fonseca LDS, Ribeiro MMF, Chermut TR, Moura MC, Oliveira LC, Paiva BR, Cardozo LF, Capistrano ESM, Mafra D. Effects of intradialytic bicycle ergometer exercise on transcription factors NF-kB and Nrf2 in patients with chronic kidney disease: A randomized crossover clinical trial. J Bodyw Mov Ther. 2024 Oct;40:1492-1501. doi: 10.1016/j.jbmt.2024.08.003. Epub 2024 Aug 8.
- Derived from this study: PubMed 36152526Brito 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Mafra, PhD principal investigator
Federal university fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Chronic Kidney Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory biomarkers (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04375553, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.