Aerobic Exercise in Patients With CKD

NCT04375553 | Completed

• 1 other identifier: Denise Mafra 5
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks

• Uremic toxins

  Evaluation of P-Cresyl Sulfate, Indoxyl Sulfate (IS), Indole 3-Acetic Acid, Trimethyl N-oxide (TMAO) and lipopolysaccharides (LPSs).

  12 weeks

Study Arms (2)

Exercise group

ACTIVE COMPARATOR

Intradialytic aerobic exercise, 3 times a week, for 12 weeks.

Other: Aerobic exercise

Non-exercise group

NO INTERVENTION

Without intradialytic aerobic exercise for 12 weeks.

Interventions

Aerobic exercise OTHER

Intradialytic aerobic exercise

Exercise group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260-050, Brazil

Location

Related Publications (2)

• 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.

  PMID: 39593477 DERIVED

• 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.

  PMID: 36152526 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Denise Mafra, PhD

  Federal university fluminense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 5, 2020
• Study Start: January 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 5, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)