Handgrip Exercise for Arteriovenous Fistula Maturation

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061008
• Other study ID #: REC No : 07/WNo01/4
• Secondary ID: Macdonald 07/4
• Status: Completed
• Phase: N/A
• First received: January 22, 2010
• Last updated: June 11, 2014
• Start date: January 2008
• Est. completion date: January 2012

Study information

• Verified date: June 2014
• Source: Bangor University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Post operative progressive handgrip exercise
As soon as possible post operation the patient will commence an eight week progressive handgrip training intervention
• Treatment as usual
Continue routine care, with removal of exercise information given to patients(if anye.g. do not give out squeeze balls)

Locations

Country	Name	City	State
United Kingdom	Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust	Bangor	Gwynedd

Sponsors (2)

Lead Sponsor	Collaborator
Bangor University	Betsi Cadwaladr University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 months	No
Secondary	Maximum Handgrip Strength		3 months	No
Secondary	Handgrip Endurance		3 months	No
Secondary	Forearm Muscle Cross Sectional Area		3 months	No