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Effect of Exercise on Blood Coagulation in Persons With Chronic Spinal Cord Injury

NCT ID: NCT00223912

Last Updated: 2010-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Disease Spinal Cord Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Lower-extremity functional electrical stimulation

Group Type OTHER

ERGYS BikeFunctional Electrical Stimulation Ergometry

Intervention Type DEVICE

A

Interventions

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ERGYS BikeFunctional Electrical Stimulation Ergometry

A

Intervention Type DEVICE

Eligibility Criteria

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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

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Department of Veterans Affairs

Principal Investigators

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Nighat Kahn, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Bronx

Locations

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VA Medical Center, Bronx

The Bronx, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.unitedspinal.org

Click here for more information about this study: Effect of FES- Exercise on Hemostasis in Persons with Chronic Spinal Cord Injury

Other Identifiers

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1124-03-0010

Identifier Type: -

Identifier Source: secondary_id

MIRB#_00514

Identifier Type: -

Identifier Source: secondary_id

B3168P

Identifier Type: -

Identifier Source: org_study_id