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Handgrip Exercise for Arteriovenous Fistula Maturation

This study is currently recruiting participants.
Verified November 2011 by Bangor University
Sponsor:
Collaborator:
Betsi Cadwaladr University Health Board
Information provided by (Responsible Party):
Bangor University
ClinicalTrials.gov Identifier:
NCT01061008
First received: January 22, 2010
Last updated: November 24, 2011
Last verified: November 2011
History of Changes
  Purpose

The purpose of this study is to investigate whether post operative progressive forearm exercise is effective in improving arteriovenous fistula maturation in chronic kidney disease patients.


Condition Intervention
Chronic Kidney Disease
 Other: Post operative progressive handgrip exercise
Other: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Progressive Handgrip Exercise Training on Arteriovenous Fistula Maturation in Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bangor University:

Primary Outcome Measures:
  • Intra access flow; arterial and venous diameter. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum handgrip strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • handgrip endurance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Forearm muscle cross sectional area [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Handgrip exercise
Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
 Other: Post operative progressive handgrip exercise
As soon as possible post operation the patient will commence an eight week progressive handgrip training intervention
Active Comparator: Treatment as usual Other: Treatment as usual
Continue routine care, with removal of exercise information given to patients(if anye.g. do not give out squeeze balls)

Detailed Description:

The arteriovenous fistula is considered to be the gold standard form of access for haemodialysis patients, however only 37% of haemodialysis patients have this form of access. A possible explanation for this could be the high fistula failure rate due to the lack of maturation. Therefore interventions aimed at enhancing fistula maturation are warranted. One such intervention could be forearm exercise, however this recommendation is not evidence based. Therefore, the purpose of this study is to investigate whether a program of post operative progressive hand grip exercise can improve fistula maturation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 4-5 chronic kidney disease, attending for arteriovenous fistula creation in forearm

Exclusion Criteria:

  • Are under the age of 18years;
  • Not able to exercise forearm safely (as decided by the patients consultant)
  • Have any other uncontrolled medical condition
  • Unable to withstand transiently raised systolic blood pressure by 35 mmHg and diastolic by 25 mmHg
  • Or are unable to give consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061008

Locations
United Kingdom
Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust Recruiting
Bangor, Gwynedd, United Kingdom, LL57 2PW
Contact: Dr. Jamie H Macdonald, PhD     00441248383272     j.h.macdonald@bangor.ac.uk    
Contact: Danielle L Kirkman, MSc     0441248388254     pepa03@bangor.ac.uk    
Principal Investigator: Dr Jamie H Macdonald, PhD            
Sponsors and Collaborators
Bangor University
Betsi Cadwaladr University Health Board
  More Information

No publications provided

Responsible Party: Bangor University
ClinicalTrials.gov Identifier: NCT01061008     History of Changes
Other Study ID Numbers: REC No : 07/WNo01/4, Macdonald 07/4
Study First Received: January 22, 2010
Last Updated: November 24, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Bangor University:
Exercise; arteriovenous fistula; chronic kidney disease

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
 Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013