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Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients (PRT)

This study has been completed.
Sponsor:
Collaborator:
Betsi Cadwaladr University Health Board
Information provided by (Responsible Party):
Bangor University
ClinicalTrials.gov Identifier:
NCT01007838
First received: October 15, 2009
Last updated: January 3, 2012
Last verified: December 2011
Results First Received: November 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Kidney Disease
Interventions: Other: Progressive resistance training programme
Other: Sham exercise
Other: Progressive resistance training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Chronic kidney patients were recruited from local renal units. Healthy controls were recruited from the North Wales Community. Recruitment period was from January 2009 to July 2011.

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
Chronic Kidney Disease Progressive Resistance Training Group Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
Chronic Kidney Disease Sham Exercise Group Lower body stretching exercise using the easiest rehabilitation elastic Theraband
Healthy Controls Progressive Resistance Training Group Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
Healthy Controls Sham Exercise Group Lower body stretching exercise using the easiest rehabilitation elastic Theraband

Participant Flow:   Overall Study
    Chronic Kidney Disease Progressive Resistance Training Group     Chronic Kidney Disease Sham Exercise Group     Healthy Controls Progressive Resistance Training Group     Healthy Controls Sham Exercise Group  
STARTED     12     11     5     4  
COMPLETED     9     11     5     4  
NOT COMPLETED     3     0     0     0  
Withdrawal by Subject                 1                 0                 0                 0  
Physician Decision                 1                 0                 0                 0  
Started home haemodialysis                 1                 0                 0                 0  



  Baseline Characteristics
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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
Chronic Kidney Disease Progressive Resistance Training Group Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
Chronic Kidney Disease Sham Exercise Group Lower body stretching exercise using the easiest rehabilitation elastic Theraband
Healthy Controls Progressive Resistance Training Group Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
Healthy Controls Sham Exercise Group Lower body stretching exercise using the easiest rehabilitation elastic Theraband
Total Total of all reporting groups

Baseline Measures
    Chronic Kidney Disease Progressive Resistance Training Group     Chronic Kidney Disease Sham Exercise Group     Healthy Controls Progressive Resistance Training Group     Healthy Controls Sham Exercise Group     Total  
Number of Participants  
[units: participants]
  12     11     5     4     32  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     8     6     4     4     22  
>=65 years     4     5     1     0     10  
Age  
[units: years]
Mean ± Standard Deviation
  48  ± 18     67  ± 16     51  ± 13     40  ± 17     51  ± 17  
Gender  
[units: participants]
         
Female     5     4     3     4     16  
Male     7     7     2     0     16  
Region of Enrollment  
[units: participants]
         
United Kingdom     12     11     5     4     32  



  Outcome Measures

1.  Primary:   Muscle Cross Sectional Area   [ Time Frame: Change from baseline in cross sectional area at 12 weeks ]

2.  Secondary:   Muscle Strength   [ Time Frame: Change from baseline in muscle strength at 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Small sample size in healthy control group. Variable gender mix in all groups.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Danielle Kirkman
Organization: UWalesBangor
phone: 00 44 1248 388254
e-mail: pepa03@bangor.ac.uk


No publications provided


Responsible Party: Bangor University
ClinicalTrials.gov Identifier: NCT01007838     History of Changes
Other Study ID Numbers: R& D Ref no: MACDONALD 07/53
Study First Received: October 15, 2009
Results First Received: November 24, 2011
Last Updated: January 3, 2012
Health Authority: United Kingdom: National Health Service