Effects of Exercise in People With Tetraplegia

NCT01202019 | Completed

• 1 other identifier: TMP-MN-005
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 (SCI). The primary purpose of this study is to improve fitness and function, reduce cardiovascular disease risks, and enhance oxidation of dietary and body fats in persons with chronic tetraplegia through acute exercise, exercise conditioning, and dietary supplementation. This study will test the hypothesis that timing of supplementation with regards to exercise bout ('intervention/placebo') affects fitness, function, lipid profiles, lipid oxidation, and inflammatory markers after acute exercise and chronic conditioning.

Conditions

Spinal Cord Injury; Tetraplegia

Keywords

cardiovascular risk; exercise; post-exercise diet supplementation

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) for lipemia

  The post-prandial lipemia is assessed by the AUC for triglycerides.

  4 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: Circuit Resistance Training (CRT)

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: Circuit Resistance Training (CRT)

Interventions

Circuit Resistance Training (CRT) OTHER

CRT will occur 3 times per week for 26 weeks. Each session will last approximately 40-45 minutes and employ resistance training (weight lifting) and endurance activities (reciprocal arm exercise, Vita-Glide®, RehaMed International) with interposed periods of incomplete recovery (i.e., heart rate not falling to baseline).

Placebo; Supplement

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• SCI resulting in tetraplegia at C5-C8
• injury for more than one year
• American Spinal Injury Association Impairment Scale (AIS) grade A-C injuries

You may not qualify if:

• 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.

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; Quadriplegia; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

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: Study Prinicipal Investigator

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 15, 2010
• Study Start: March 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

US (1)