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Handgrip Exercise for Arteriovenous Fistula Maturation

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Post operative progressive handgrip exercise
Treatment as usual
Sponsored by
Bangor University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Kidney Disease focused on measuring Exercise; arteriovenous fistula; chronic kidney disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Handgrip exercise

Treatment as usual

Arm Description

Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program

Outcomes

Primary Outcome Measures

Venous Diameter.
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).

Secondary Outcome Measures

Maximum Handgrip Strength
Handgrip Endurance
Forearm Muscle Cross Sectional Area

Full Information

First Posted
January 22, 2010
Last Updated
June 11, 2014
Sponsor
Bangor University
Collaborators
Betsi Cadwaladr University Health Board
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1. Study Identification

Unique Protocol Identification Number
NCT01061008
Brief Title
Handgrip Exercise for Arteriovenous Fistula Maturation
Official Title
The Effects of Progressive Handgrip Exercise Training on Arteriovenous Fistula Maturation in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bangor University
Collaborators
Betsi Cadwaladr University Health Board

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Exercise; arteriovenous fistula; chronic kidney disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Handgrip exercise
Arm Type
Experimental
Arm Description
Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
Arm Title
Treatment as usual
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Post operative progressive handgrip exercise
Intervention Description
As soon as possible post operation the patient will commence an eight week progressive handgrip training intervention
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Continue routine care, with removal of exercise information given to patients(if anye.g. do not give out squeeze balls)
Primary Outcome Measure Information:
Title
Venous Diameter.
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Maximum Handgrip Strength
Time Frame
3 months
Title
Handgrip Endurance
Time Frame
3 months
Title
Forearm Muscle Cross Sectional Area
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust
City
Bangor
State/Province
Gwynedd
ZIP/Postal Code
LL57 2PW
Country
United Kingdom

12. IPD Sharing Statement

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Handgrip Exercise for Arteriovenous Fistula Maturation

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