Effects of Physical Activities on the Expression of Nrf2 and Nf-kb Hemodialysis Patients (Hemodialysis)

October 18, 2020 updated by: Denise Mafra, Universidade Federal Fluminense

Effects of a Program of Strength Physical Activities on the Expression of Nrf2 and Nf-kb Hemodialysis Patients

Oxidative stress and inflammation are cardiovascular risk factors in patients with chronic kidney disease (CKD) undergoing hemodialysis (HD). Nuclear transcription factors play roles in the coordinated expression of genes involved in inflammation, such as nuclear factor Kappa B (NFkB) that increase the cytokines synthesis and Nuclear factor erythroid 2-related factor 2 (Nrf2) that increase the transcription of genes encoding enzymes of phase II detoxifying and antioxidant enzymes. The aim of this study was to evaluate the effects of resistance exercise program on the expression of transcription factors Nrf2 and NF-kB in HD patients.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This study included 44 patients on regular HD program which 25 patients (54.5% women, age 45.7 ± 15.2 years and time on dialysis, 71.2 ± 45.5 months) composed the exercise group and 19 patients (61.5% women, age 42.5 ± 13.5 years and time on dialysis, 70.1 ± 49.9 months) the control group. The exercise program was performed during HD sessions, 3 times a week (36 exercises sessions). Peripheral blood mononuclear cells (PBMC) were isolated and processed for expression of Nrf2, NF-kB and NADPH quinone oxidoreductase 1 (NQO1) by quantitative real-time polymerase chain reaction. Antioxidant enzymes activity (catalase-CAT and glutathione peroxidase-GPx), high-sensitivity C-reactive protein (hs-CRP) and nitric oxide (NO) products were assessed using an enzyme-linked immunosorbent assay (ELISA).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • RJ
      • Rio de Janeiro, RJ, Brazil, 22260-050
        • Denise Mafra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria were age >18 years
  • Without any motor skill disorders, arteriovenous fistula for vascular access in the upper limb and patients on maintenance dialysis for at least 6 months.

Exclusion Criteria:

  • Patients with autoimmune diseases, cancer, infectious diseases, acquired immunodeficiency syndrome, uncontrolled hypertension, unstable angina, malignant arrhythmias, pregnant, lower limb amputee, history of stroke, neurological or cardiovascular disease (moderate-intensity physical activity is not routinely recommended)
  • Taking catabolizing drugs
  • Under regular exercise
  • Smokers
  • Patients who complied with <75 % of the training were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: physical exercises group
Physical exercises were performed during HD sessions, at second hour of HD, three times per week for 3 months (36 sessions). The patients remained seated while performing the exercises that were performed in both lower limbs. Ankle-cuffs and elastic bands (Theraband®, Akron-OH, USA) were used for performed the exercises. The physical exercises consisted of four different exercises and they were administered by a physical therapist following the adapted protocol.
Physical exercises were performed during HD sessions, at second hour of HD, three times per week for 3 months. The first exercise was knee extension from 90° to 0°. The patient remained in the 0° position for 5 seconds (an isometric contraction) and then returned to the starting position (90º). 2) The second exercise consisted of a triple flexion followed by extension of the lower limbs. The patient flexed the thigh, knee and ankle (elastic band placed at the level of the metacarpals) followed by a double extension of the thigh and knee. 3) In a co-isometric contraction, the patient performed a leg extension against the ankle-cuff resistance (located under the distal third of the leg at the level of the malleolus) for 10 seconds. 4) The patient performed a unilateral hip joint flexion of the lower limb with the knee extended by rising to their functional limit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Nrf2 expression
Time Frame: changes in Nrf2 expression from baseline and 3 months
analysed by PCR real time
changes in Nrf2 expression from baseline and 3 months
Changes in cytokines plasma levels
Time Frame: changes in cytokines plasma levels from baseline and 3 months
cytokines plasma levels like interleukin-6, TNF-alpha evaluated by ELISA methods
changes in cytokines plasma levels from baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 18, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • DeniseMafra2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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