Status:
COMPLETED
Effects of Exercise in People With Paraplegia
Lead Sponsor:
University of Miami
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This hypothesis-driven study will investigate effects of physical activity with or without a nutrient supplement known to increase body lean mass in adults with chronic paraplegia who have clusters of...
Detailed Description
Obesity and obesity-related secondary complications are pandemic health hazards that are highly prevalent among persons with spinal cord injuries (SCI). Accumulation of body fat disposes persons with ...
Eligibility Criteria
Inclusion
- SCI resulting in paraplegia between T5 and L1
- injury for more than one year
- American Spinal Injury Association Impairment Scale (AIS) grade A-C injuries
- BMI ≥ 23 kg/m2 (defined by studies as the equivalent to the WHO criterion of 25 kg/m2 as 'overweight', and the point at which health risks begin to increase), plus any two or more of the following conditions on screening:
- prehypertension (BP ≥ 120/80 mmHg) by updated AHA and ADA criteria
- dyslipidemia (HDL-C ≥ 40 mg/dL or TG ≤ 150 mg/dL) by NCEP ATP III Guidelines,44 or
- impaired fasting glucose (≥ 100 mg/dL) by 2006 ADA criteria.
Exclusion
- surgery within 6 months
- pressure ulcer within 3 months
- upper limb pain that limits exercise
- recurrent acute infection or illness requiring hospitalization or IV antibiotics
- pregnancy
- previous myocardial infarction or cardiac surgery
- 6 month history of glucose lowering and lipid-lowering drug therapy
- Type I or II diabetes (by WHO criteria)
- daily intake of vitamin supplements exceeding 100% RDA
- The following medications and drug therapies will disqualify subjects from participating: beta-adrenergic antagonists, maintenance alpha-blockers, Methyldopa, thiazide and loop diuretics, parasympatholytic agents, zinc, estrogen/hormone replacement therapy excluding oral contraceptives, insulin-sensitizing drugs, and maintenance use of aspirin and nonsteroidal anti-inflammatory drugs.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01203150
Start Date
October 1 2008
End Date
September 1 2012
Last Update
March 24 2015
Active Locations (1)
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1
The Miami Project to Cure Paralysis
Miami, Florida, United States, 33136