NCT01061008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

July 15, 2014

Completed
Last Updated

July 15, 2014

Status Verified

June 1, 2014

Enrollment Period

4 years

First QC Date

January 22, 2010

Results QC Date

February 15, 2013

Last Update Submit

June 11, 2014

Conditions

Chronic Kidney Disease

Keywords

Exercise; arteriovenous fistula; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Maximum Handgrip Strength

    3 months

  • Handgrip Endurance

    3 months

  • Forearm Muscle Cross Sectional Area

    3 months

Study Arms (2)

Handgrip exercise

EXPERIMENTAL

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

Treatment as usual

ACTIVE COMPARATOR
Other: Treatment as usual

Interventions

Post operative progressive handgrip exerciseOTHER

As soon as possible post operation the patient will commence an eight week progressive handgrip training intervention

Handgrip exercise
Treatment as usualOTHER

Continue routine care, with removal of exercise information given to patients(if anye.g. do not give out squeeze balls)

Treatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust

Bangor, Gwynedd, LL57 2PW, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicMotor ActivityArteriovenous Fistula

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Results Point of Contact

Title
Dr. Jamie Macdonald
Organization
UWalesBangor
j.h.macdonald@bangor.ac.uk
+441248383272

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2010

First Posted

February 2, 2010

Study Start

January 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 15, 2014

Results First Posted

July 15, 2014

Record last verified: 2014-06

Locations

GB(1)