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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02718638
Other study ID # DeniseMafra2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date October 2020

Study information

Verified date October 2020
Source Universidade Federal Fluminense
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 2020
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Other:
physical exercises
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.

Locations

Country Name City State
Brazil Denise Mafra Rio de Janeiro RJ

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Nrf2 expression analysed by PCR real time changes in Nrf2 expression from baseline and 3 months
Primary Changes in cytokines plasma levels cytokines plasma levels like interleukin-6, TNF-alpha evaluated by ELISA methods changes in cytokines plasma levels from baseline and 3 months
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