Back to resultsExercise Capability and Training Effects in Diabetic Patients With Neuropathy
Primary Purpose
Diabetes Mellitus, Peripheral Neuropathy
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise training
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes mellitus, Peripheral neuropathy, Exercise, Balance performance
Eligibility Criteria
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.
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise Training
Control
Arm Description
aerobic exercise training
Outcomes
Primary Outcome Measures
Exercise capacity
oxygen consumption
Secondary Outcome Measures
maximal oxygen pulse
maximal oxygen content in blood of each heart beat
Full Information
NCT ID
NCT01760707
First Posted
January 2, 2013
Last Updated
January 3, 2013
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01760707
Brief Title
Exercise Capability and Training Effects in Diabetic Patients With Neuropathy
Official Title
Exercise Capability and Training Effects in Diabetic Patients With Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Peripheral Neuropathy
Keywords
Diabetes mellitus, Peripheral neuropathy, Exercise, Balance performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Training
Arm Type
Experimental
Arm Description
aerobic exercise training
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Intervention Type
Behavioral
Intervention Name(s)
usual care
Primary Outcome Measure Information:
Title
Exercise capacity
Description
oxygen consumption
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
maximal oxygen pulse
Description
maximal oxygen content in blood of each heart beat
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Tai Wu, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
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Exercise Capability and Training Effects in Diabetic Patients With Neuropathy
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