Effects of Exercise in People With Paraplegia
Spinal Cord Injury
About this trial
This is an interventional prevention trial for Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- The Miami Project to Cure Paralysis
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Supplement
Placebo
Participants randomized to the 'supplement' arm will consume a blended drink containing 48g of ionexchange, hydrolyzed vanilla-flavored whey protein (Whey to Go, Solgar Vitamin and Herb, Leonia, NJ; 3g CH2O, < 3g Total Fat). The drink will be given in split doses immediately before and after each training session, which represents a timing schedule that best stimulates muscle anabolism in persons undergoing exercise training.
As ingestion of the protein supplement is critically influenced by time of administration, participants assigned to the 'placebo' study arm will consume the identical supplement and dose on days during which training is not performed. This strategy will allow the groups to be isocaloric and equal in protein supplementation.