NCT02619968

Brief Summary

The aim of this study is to analyze the effectiveness of physical exercise with blood flow restriction on the diameter and the flow of vessels, muscle strength and circumference of the forearm in patients with CKD prior to making FAV.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Status
unknown

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

First Submitted

Initial submission to the registry

November 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1.2 years

First QC Date

November 30, 2015

Last Update Submit

November 30, 2015

Conditions

Keywords

Chronic renal failureArteriovenous fistulaIsometric exercisesVascular endothelium

Outcome Measures

Primary Outcomes (1)

  • Increasing the diameter of the cephalic vein

    Increasing the diameter of the cephalic vein of at least 0.22 mm

    8 weeks of training for each patient

Secondary Outcomes (4)

  • Increasing the diameter of the radial artery

    8 weeks of training for each patient

  • Radial artery blood flow

    8 weeks of training for each patient

  • Forearm Circumference

    8 weeks of training for each patient

  • Muscle strength of the forearm

    8 weeks of training for each patient

Study Arms (2)

Experimental group

EXPERIMENTAL

Will be held isometric and isotonic concentric to the flexor muscles of the elbow and wrist using tennis ball, halter and handgrip added to partial occlusion of blood flow to tourniquet application. Application of the tourniquet Will be held in conjunction with exercises for the experimental group. Tennis ball: will initially be 3 sets, where one series with 10 grips, increasing 5 grips every week, 60 seconds rest every series. Halter: are performed with load of 1 kg, 2 kg and 3 kg. Handgrip: they will be performed 3 sets of dynamic manual hold exercises in the intensity of 40% of MVC. Home program: at home will be performed isometric exercises with tennis ball on the same frequency as in performing ambulatory without applying the tensiometer.

Other: experimental group

Group control

SHAM COMPARATOR

Will be held the same isometric and isotonic concentric ambulatory and home with the same duration, frequency and intensity, except is not to apply the tourniquet.

Other: experimental group

Interventions

Will be held isometric and isotonic concentric to the flexor muscles of the elbow and wrist using tennis ball, halter and handgrip added to partial occlusion of blood flow to tourniquet application. The Application of the tourniquet will be held in conjunction with exercises for the experimental group.

Experimental groupGroup control

Eligibility Criteria

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

You may qualify if:

  • Patients with Chronic Kidney Disease (CKD) stage 4 or 5;
  • In conservative or dialysis treatment;
  • Medical indication of arteriovenous fistula as an achievement of HD.

You may not qualify if:

  • Cognitive impairment or changes that hinder understanding, realization of activities and interpretation of the issues;
  • a history of making FAV in both upper limbs or some other type of vascular surgery in upper limbs, with some type of vascular access in upper limbs or in nearby regions;
  • to develop some kind of manual work with heavy loads;
  • Trauma-orthopedic lesions in the cervical, shoulder, elbow, wrist and untreated (or) hand;
  • Signs of thrombophlebitis and hypoplasia / agenesis of the upper limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Levey AS, Coresh J. Chronic kidney disease. Lancet. 2012 Jan 14;379(9811):165-80. doi: 10.1016/S0140-6736(11)60178-5. Epub 2011 Aug 15.

    PMID: 21840587BACKGROUND
  • National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.

    PMID: 11904577BACKGROUND
  • Lugon JR. End-stage renal disease and chronic kidney disease in Brazil. Ethn Dis. 2009 Spring;19(1 Suppl 1):S1-7-9.

    PMID: 19484865BACKGROUND
  • Rus RR, Ponikvar R, Kenda RB, Buturovic-Ponikvar J. Effect of local physical training on the forearm arteries and veins in patients with end-stage renal disease. Blood Purif. 2003;21(6):389-94. doi: 10.1159/000073441.

    PMID: 14586181BACKGROUND
  • Rus RR, Ponikvar R, Kenda RB, Buturovic-Ponikvar J. Effect of intermittent compression of upper arm veins on forearm vessels in patients with end-stage renal disease. Hemodial Int. 2005 Jul;9(3):275-80. doi: 10.1111/j.1492-7535.2005.01142.x.

    PMID: 16191078BACKGROUND
  • Kumar S, Seward J, Wilcox A, Torella F. Influence of muscle training on resting blood flow and forearm vessel diameter in patients with chronic renal failure. Br J Surg. 2010 Jun;97(6):835-8. doi: 10.1002/bjs.7004.

    PMID: 20309951BACKGROUND
  • Nantakool S, Reanpang T, Prasannarong M, Pongtam S, Rerkasem K. Upper limb exercise for arteriovenous fistula maturation in people requiring permanent haemodialysis access. Cochrane Database Syst Rev. 2022 Oct 3;10(10):CD013327. doi: 10.1002/14651858.CD013327.pub2.

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, ChronicArteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Study Officials

  • Jefferson B Barbosa, physiotherapist

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jefferson B Barbosa, physiotherapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
postgraduate in integrated multidisciplinary residency in health, concentration area in physical therapy in nephrology

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 2, 2015

Study Start

January 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

December 2, 2015

Record last verified: 2015-11