Physical Exercise With Flow Restriction of the Forearm in Chronic Kidney Disease
Effectiveness of Physical Exercise With Flow Restriction on the Diameter and the Flow of the Blood Vessels of the Forearm in Chronic Kidney Disease: a Randomized Clinical Trial
1 other identifier
interventional
20
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
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
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedDecember 2, 2015
November 1, 2015
1.2 years
November 30, 2015
November 30, 2015
Conditions
Keywords
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
EXPERIMENTALWill 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.
Group control
SHAM COMPARATORWill 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.
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.
Eligibility Criteria
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: 21840587BACKGROUNDNational 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: 11904577BACKGROUNDLugon JR. End-stage renal disease and chronic kidney disease in Brazil. Ethn Dis. 2009 Spring;19(1 Suppl 1):S1-7-9.
PMID: 19484865BACKGROUNDRus 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: 14586181BACKGROUNDRus 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: 16191078BACKGROUNDKumar 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: 20309951BACKGROUNDNantakool 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.
PMID: 36184076DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jefferson B Barbosa, physiotherapist
Universidade Federal de Pernambuco
Central Study Contacts
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