Effects of Exercise in People With Paraplegia

Completed · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injury

In brief

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 obesity and obesity-related secondary complications.

Key facts

Study ID

NCT01203150

Run by

University of Miami

People needed

32

Starts

2008-10-01

Expected to finish

2012-09-01

Last updated by the study team

2015-03-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Miami Project to Cure Paralysis — Miami, Florida, United States

Full record on ClinicalTrials.gov

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