Effects of Exercise in People With Paraplegia

NCT01203150 | Completed DMC

• 1 other identifier: TMP-MN-006
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 obesity and obesity-related secondary complications.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Global cardiovascular disease risk score

  Global cardiovacular disease risk will be generated by evaluating blood metabolism in the fasting and fed state for inflammatory disease markers including total cholesterol: high density lipoprotein ratio (TC: HDL ratio), post-prandial lipemia (PPL), whole body fat oxidation (WBFO), insulin resistance, and inflammatory mediators.

  4 visits over 9 months

Secondary Outcomes (3)

• Body composition

  4 visits over 9 months

• Cardiovascular Endurance

  4 visits over 9 months

• Muscular strength

  8 visits over 9 months

Study Arms (2)

Supplement

EXPERIMENTAL

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.

Other: Exercise

Placebo

PLACEBO COMPARATOR

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.

Other: Exercise

Interventions

Exercise OTHER

CRT will occur 3 times per week for 26 weeks. Each training session will last approximately 40-45 minutes and employ resistance training (weight lifting) and high-speed, low intensity endurance activities (arm cranking) with interposed periods of incomplete recovery (i.e., heart rate not falling to baseline).

Also known as: Circuit Resistance Training (CRT)

Placebo; Supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mark S Nash, PhD

  University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: October 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

US (1)