NCT02718638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

2.8 years

First QC Date

December 1, 2015

Last Update Submit

October 18, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes in Nrf2 expression

    analysed by PCR real time

    changes in Nrf2 expression from baseline and 3 months

  • 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

Study Arms (1)

physical exercises group

OTHER

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.

Other: physical exercises

Interventions

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.

physical exercises group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Without any motor skill disorders, arteriovenous fistula for vascular access in the upper limb and patients on maintenance dialysis for at least 6 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denise Mafra

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

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertensionDiabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 1, 2015

First Posted

March 24, 2016

Study Start

January 1, 2013

Primary Completion

November 1, 2015

Study Completion

October 1, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations