- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02718638
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
Conditions
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
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Rio de Janeiro, RJ, Brazil, 22260-050
- Denise Mafra
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-
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.
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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
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cytokines plasma levels like interleukin-6, TNF-alpha evaluated by ELISA methods
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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.
Sponsor
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
Additional Relevant MeSH Terms
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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