Effect of Exercise on Blood Coagulation in Persons With Chronic Spinal Cord Injury - Full Text View

Purpose

The purpose of this study is to determine if exercise affects the clotting of blood (hemostasis). The effect of exercise on hemostasis will be determined in persons with spinal cord injury, a population reported to have an increased prevalence of cardiovascular disease (CVD). It is expected that this study will increase our understanding of CVD in persons with SCI, and it will eventually help reduce the occurrence of premature heart disease.

Condition	Intervention
Cardiovascular Disease Spinal Cord Injury	Device: ERGYS BikeFunctional Electrical Stimulation Ergometry

MedlinePlus related topics:

Exercise and Physical Fitness Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	Effect of FES- Exercise on Hemostasis in Persons With Chronic Spinal Cord Injury

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

FES cycle ergometry was performed for 8 sessions. Before and after exercise (sessions 1 and 8), blood samples were collected. [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	November 2003
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Device: ERGYS BikeFunctional Electrical Stimulation Ergometry

Detailed Description:

Regular moderate intensity physical exercise decreases platelet aggregability as a consequence of increasing levels of tissue plasminogen activator (tPA) and reducing levels of plasminogen activator inhibitor-1 (PAI-1). In addition, the exercise-associated improvement in the lipid profile and reduction in fat mass may decrease platelet aggregability and blood coagulation, as well as increase fibrinolysis. Thus, it can be hypothesized that physical exercise training has a powerful beneficial impact on blood coagulation and fibrinolysis. Although, regular exercise has been shown to reduce the incidence of CVD and death or causes a regression of symptoms in able-bodied individuals, this salutary effect of prolonged (months) exercise in persons with SCI has not been documented. The present study will evaluate the effects on hemostasis of exercise training in persons with chronic SCI. The effect of exercise on hemostasis will be determined in persons with SCI, a population appreciated to have an increased prevalence of cardiovascular disease (CVD). It is anticipated that this study will ultimately increase our understanding of CVD in this group, and it will eventually help reduce the occurrence of premature macrovascular disease.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

SCI subjects (n=12) with stable chronic, complete paraplegia, (T1 to T10) and quadriplegia (C4 to C8) (for more than 1 year) will be recruited. The paraplegia subjects should be able to transfer independently in/out of a wheelchair.

Exclusion Criteria:

Ambulatory persons with SCI
Less than 18 years or greater than 65 years old
Chronic illness (dialysis)
Evidence or history of heart and/or vessel disease (arrhythmias, ischemia at rest)
Platelet or coagulation disorders
Prescribed use of on aspirin or non-steroidal anti inflammatory drugs
Active illness (sepsis, pressure sores)
Uncontrolled spasticity
Contractures (fixed) in upper extremity/lower extremity Heterotopic ossification at hips, knees, that limit range of motion while seated for FES

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223912

Locations


United States, New York
	VA Medical Center, Bronx
	Bronx, New York, United States, 10468

Sponsors and Collaborators

Department of Veterans Affairs

Investigators


Principal Investigator:	Nighat Kahn, PhD	VA Medical Center, Bronx

More Information

Click here for more information about this study: Effect of FES- Exercise on Hemostasis in Persons with Chronic Spinal Cord Injury This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications of Results:

Wang JS, Yang CF, Wong MK. Effect of strenuous arm crank exercise on platelet function in patients with spinal cord injury. Arch Phys Med Rehabil. 2002 Feb;83(2):210-6.

Kahn NN, Bauman WA, Sinha AK. Appearance of a novel prostacyclin receptor antibody and duration of spinal cord injury. J Spinal Cord Med. 2005;28(2):97-102.

Other Publications:

Bauman WA, Kahn NN, Grimm DR, Spungen AM. Risk factors for atherogenesis and cardiovascular autonomic function in persons with spinal cord injury. Spinal Cord. 1999 Sep;37(9):601-16. Review. No abstract available.

Responsible Party:	Department of Veterans Affairs ( Kahn, Nighat - Principal Investigator )
Study ID Numbers:	B3168P, 1124-03-0010, MIRB#_00514
First Received:	September 14, 2005
Last Updated:	March 10, 2008
ClinicalTrials.gov Identifier:	NCT00223912
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Cardiovascular Disease

Exercise

Functional electrical stimulation

hemostasis

Spinal cord injury

Study placed in the following topic categories:

Spinal Cord Injuries

Spinal Cord Diseases

Wounds and Injuries

Disorders of Environmental Origin

Central Nervous System Diseases

Trauma, Nervous System

Additional relevant MeSH terms:

Nervous System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00223912