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Exercise Capability and Training Effects in Diabetic Patients With Neuropathy

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ClinicalTrials.gov Identifier: NCT01760707
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date January 4, 2013
Study Start Date  ICMJE November 2002
Actual Primary Completion Date April 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
Exercise capacity [ Time Frame: 8 weeks ]
oxygen consumption
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
maximal oxygen pulse [ Time Frame: 8 weeks ]
maximal oxygen content in blood of each heart beat
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Capability and Training Effects in Diabetic Patients With Neuropathy
Official Title  ICMJE Exercise Capability and Training Effects in Diabetic Patients With Neuropathy
Brief Summary The purpose of the study was to investigate the effects of training on the exercise capability, balance performance, and microcirculation. Furthermore, to search the possible underlying mechanisms.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Peripheral Neuropathy
Intervention  ICMJE
  • Behavioral: exercise training
  • Behavioral: usual care
Study Arms  ICMJE
  • Experimental: Exercise Training
    aerobic exercise training
    Intervention: Behavioral: exercise training
  • Active Comparator: Control
    Intervention: Behavioral: usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2013)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2003
Actual Primary Completion Date April 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 diabetes with neuropathy.

Exclusion Criteria:

  • Central nerve system dysfunction, hemiparesis, motion tremor, other musculoskeletal disease that might effect the outcome measurements.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760707
Other Study ID Numbers  ICMJE 9200200769
NSC92-2314-B-002-130
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ying-Tai Wu, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP