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

Primary Purpose

Chronic Kidney Disease, Hypertension, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
physical exercises
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Denise Mafra

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

physical exercises group

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in Nrf2 expression
analysed by PCR real time
Changes in cytokines plasma levels
cytokines plasma levels like interleukin-6, TNF-alpha evaluated by ELISA methods

Secondary Outcome Measures

Full Information

First Posted
December 1, 2015
Last Updated
October 18, 2020
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT02718638
Brief Title
Effects of Physical Activities on the Expression of Nrf2 and Nf-kb Hemodialysis Patients
Acronym
Hemodialysis
Official Title
Effects of a Program of Strength Physical Activities on the Expression of Nrf2 and Nf-kb Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hypertension, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physical exercises group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
physical exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Nrf2 expression
Description
analysed by PCR real time
Time Frame
changes in Nrf2 expression from baseline and 3 months
Title
Changes in cytokines plasma levels
Description
cytokines plasma levels like interleukin-6, TNF-alpha evaluated by ELISA methods
Time Frame
changes in cytokines plasma levels from baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Denise Mafra
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22260-050
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
35018639
Citation
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
Results Reference
derived

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

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