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Effects of Exercise in People With Tetraplegia

Primary Purpose

Spinal Cord Injury, Tetraplegia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Circuit Resistance Training (CRT)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury focused on measuring cardiovascular risk, exercise, post-exercise diet supplementation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • The Miami Project to Cure Paralysis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Supplement

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Area Under the Curve (AUC) for lipemia
The post-prandial lipemia is assessed by the AUC for triglycerides.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2010
Last Updated
July 21, 2014
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT01202019
Brief Title
Effects of Exercise in People With Tetraplegia
Official Title
Effects of Exercise on Post-Prandial Lipemia and Fat Oxidation After Tetraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Much as in the general population, cardiovascular disease (CVD) is a leading cause of death in persons with spinal cord injury. However, CVD occurs earlier in life for those with SCI, progresses silently, and manifests atypical symptoms which fail to warn of impending ischemic damage. This accelerated development of CVD is multimodal in cause, including, but not limited to: a sedentary lifestyle, decreased muscle mass, increased fat mass, and physiologic alterations in lipid metabolism, all attributable in part to SCI. Traditional methods of dietary modification and exercise intervention are likely insufficient to elicit adequate modification of post-SCI physiology to prevent CVD. Secondary to our purposes, but of immediate importance to an individual with SCI is the impact of a sedentary lifestyle and increased obesity on their ability to remain independent. A quarter of young persons with SCI possess levels of fitness which are inadequate to complete essential activities of daily living. Thus, a sedentary lifestyle, as measured by fitness, is a correlate if not perceptive of morbidity and mortality in persons with SCI. Atherosclerosis has recently been defined as an inflammatory disease. C-reactive protein has emerged as a general marker of inflammation and is elevated in persons with SCI. We have demonstrated persons with SCI have a pathophysiologic lipid uptake response to a high fat meal, the endpoint of which is increased vascular oxidative stress, a precursor to CVD, indexed by endothelial microparticles. We have also demonstrated circuit resistance training favorably alters lipid profiles of persons with paraplegia. Research in able-bodied individuals suggests acute bouts of exercise accelerate postprandial lipid metabolism (PPL). Post-exercise supplementation has been demonstrated to improve gains in both lean muscle mass and performance over exercise alone in both the able-bodied and individuals with spinal cord injury. Targeting inflammation, post-prandial lipidemia, and altering lipid profiles through dietary and exercise interventions may be a method to reverse or pre-empt the development of CVD in persons with SCI. Increasing muscle mass and physical performance through the same interventions may improve physical performance and thus independence in activities of daily living in persons with SCI. In addition, exercise may serve to decrease depression and anxiety in persons with SCI, much as in non-disabled persons. Targeted exercise plus timed supplementation may decrease the accelerated morbidity and mortality of persons with SCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Tetraplegia
Keywords
cardiovascular risk, exercise, post-exercise diet supplementation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Circuit Resistance Training (CRT)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC) for lipemia
Description
The post-prandial lipemia is assessed by the AUC for triglycerides.
Time Frame
4 visits over 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: SCI resulting in tetraplegia at C5-C8 injury for more than one year American Spinal Injury Association Impairment Scale (AIS) grade A-C injuries Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Nash, PhD
Organizational Affiliation
University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miami Project to Cure Paralysis
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

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Effects of Exercise in People With Tetraplegia

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