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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Handgrip Exercise Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
Treatment as Usual No text entered.

Participant Flow:   Overall Study
    Handgrip Exercise   Treatment as Usual
STARTED   16   15 
COMPLETED   10   9 
NOT COMPLETED   6   6 
Badiocephalic fistula failed                3                2 
Death                1                0 
Withdrawal by Subject                1                3 
Unable to exercise following surgery                1                0 
Adverse Event                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Handgrip Exercise Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
Treatment as Usual No text entered.
Total Total of all reporting groups

Baseline Measures
   Handgrip Exercise   Treatment as Usual   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   15   31 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   16   15   31 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (14)   60  (11)   56  (12) 
Gender 
[Units: Participants]
     
Female   5   4   9 
Male   11   11   22 
Region of Enrollment 
[Units: Participants]
     
United Kingdom   16   15   31 


  Outcome Measures

1.  Primary:   Venous Diameter.   [ Time Frame: 3 months ]

2.  Secondary:   Maximum Handgrip Strength   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Handgrip Endurance   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Forearm Muscle Cross Sectional Area   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: j.h.macdonald@bangor.ac.uk



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