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Handgrip Exercise for Arteriovenous Fistula Maturation

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ClinicalTrials.gov Identifier: NCT01061008
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Sponsor:
Collaborator:
Betsi Cadwaladr University Health Board
Information provided by (Responsible Party):
Bangor University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Basic Science
Condition Chronic Kidney Disease
Interventions Other: Post operative progressive handgrip exercise
Other: Treatment as usual
Enrollment 31
Recruitment Details Patients with stage four and five CKD attending two renal units in North Wales, UK were invited to participate in the study.
Pre-assignment Details  
Arm/Group Title Handgrip Exercise Treatment as Usual
Hide Arm/Group Description Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program [Not Specified]
Period Title: Overall Study
Started 16 15
Completed 10 9
Not Completed 6 6
Reason Not Completed
Badiocephalic fistula failed             3             2
Death             1             0
Withdrawal by Subject             1             3
Unable to exercise following surgery             1             0
Adverse Event             0             1
Arm/Group Title Handgrip Exercise Treatment as Usual Total
Hide Arm/Group Description Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
15
 100.0%
31
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
52  (14) 60  (11) 56  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
5
  31.3%
4
  26.7%
9
  29.0%
Male
11
  68.8%
11
  73.3%
22
  71.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 16 participants 15 participants 31 participants
16 15 31
1.Primary Outcome
Title Venous Diameter.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Handgrip Exercise Treatment as Usual
Hide Arm/Group Description:
Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
[Not Specified]
Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: mm
5.78  (0.51) 6.42  (0.89)
2.Secondary Outcome
Title Maximum Handgrip Strength
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Handgrip Endurance
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Forearm Muscle Cross Sectional Area
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
Time Frame 8 weeks
Adverse Event Reporting Description Including joint, muscle or wound pain was recorded by the patient and also collected actively by the researcher during each weekly phone call to the patient. Other unexpected and serious (fatal, life threatening, or resulted in hospitalization) harms were collected passively as they occurred and during the trial period only.
 
Arm/Group Title Handgrip Exercise Treatment as Usual
Hide Arm/Group Description Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program [Not Specified]
All-Cause Mortality
Handgrip Exercise Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Handgrip Exercise Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Handgrip Exercise Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/10 (20.00%)      0/9 (0.00%)    
Surgical and medical procedures     
Pain   2/10 (20.00%)  4 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jamie Macdonald
Organization: UWalesBangor
Phone: +441248383272
Responsible Party: Bangor University
ClinicalTrials.gov Identifier: NCT01061008     History of Changes
Other Study ID Numbers: REC No : 07/WNo01/4
Macdonald 07/4 ( Other Identifier: R & D Reference No )
First Submitted: January 22, 2010
First Posted: February 2, 2010
Results First Submitted: February 15, 2013
Results First Posted: July 15, 2014
Last Update Posted: July 15, 2014