Handgrip Exercise for Arteriovenous Fistula Maturation

June 11, 2014 updated by: Bangor University

The Effects of Progressive Handgrip Exercise Training on Arteriovenous Fistula Maturation in Chronic Kidney Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Gwynedd
      • Bangor, Gwynedd, United Kingdom, LL57 2PW
        • Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous Diameter.
Time Frame: 3 months
Measurements were made using duplex ultrasonagraphy. Measurements were made at predetermined distances 5 to 10 cm proximal to the anastomosis (dependent on wound dressings and turbulent flow around the anastomosis). The scanning position for each patient was traced using transparent sheets which allowed analogous measurement positions for all scans. Cross sectional vascular diameter measurements were made using conventional grey scale B Mode imaging. Diameters were measured from the inner edges of the vascular wall (Wiese & Nonnast-Daniel, 2004).
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum Handgrip Strength
Time Frame: 3 months
3 months
Handgrip Endurance
Time Frame: 3 months
3 months
Forearm Muscle Cross Sectional Area
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangor University

Collaborators

Betsi Cadwaladr University Health Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

June 11, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC No : 07/WNo01/4
  • Macdonald 07/4 (Other Identifier: R & D Reference No)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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