Status:
COMPLETED
Effects of Exercise in People With Tetraplegia
Lead Sponsor:
University of Miami
Conditions:
Spinal Cord Injury
Tetraplegia
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This study is designed to assess the impact of exercise and supplementation on measures of fitness, function, and cardiovascular disease risk factors/modifiers in individuals with spinal cord injury (...
Detailed Description
Much as in the general population, cardiovascular disease (CVD) is a leading cause of death in persons with spinal cord injury. However, CVD occurs earlier in life for those with SCI, progresses silen...
Eligibility Criteria
Inclusion
- SCI resulting in tetraplegia at C5-C8
- injury for more than one year
- American Spinal Injury Association Impairment Scale (AIS) grade A-C injuries
Exclusion
- Surgery within 6 months;
- pressure ulcer within 3 months;
- upper limb pain that limits completion of exercise;
- recurrent acute infection or illness requiring hospitalization or IV antibiotics;
- pregnancy;
- previous myocardial infarction or cardiac surgery;
- history of glucose-lowering and lipid-lowering drug therapy;
- Type I or II diabetes (by World Health Organization criteria). The following medications and drug therapies will disqualify subjects from participating in the study: beta-adrenergic antagonists, maintenance alpha-adrenergic blockers, Methyldopa, thiazide and loop diuretics, parasympatholytic agents, zinc, estrogen/hormone replacement therapy excluding oral contraceptives, insulin-sensitizing drugs, aspirin, and non-steroidal anti-inflammatory drugs.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01202019
Start Date
March 1 2008
End Date
September 1 2011
Last Update
July 22 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Miami Project to Cure Paralysis
Miami, Florida, United States, 33136