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

Primary Purpose

Cardiovascular Disease, Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ERGYS BikeFunctional Electrical Stimulation Ergometry
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring Cardiovascular Disease, Exercise, Functional electrical stimulation, hemostasis, Spinal cord injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Medical Center, Bronx

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Lower-extremity functional electrical stimulation

Outcomes

Primary Outcome Measures

FES cycle ergometry was performed for 8 sessions. Before and after exercise blood samples were collected and platelet aggregation and blood coagulation analysis were performed.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
September 15, 2010
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00223912
Brief Title
Effect of Exercise on Blood Coagulation in Persons With Chronic Spinal Cord Injury
Acronym
FES
Official Title
Effect of FES- Exercise on Hemostasis in Persons With Chronic Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Spinal Cord Injury
Keywords
Cardiovascular Disease, Exercise, Functional electrical stimulation, hemostasis, Spinal cord injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Lower-extremity functional electrical stimulation
Intervention Type
Device
Intervention Name(s)
ERGYS BikeFunctional Electrical Stimulation Ergometry
Intervention Description
A
Primary Outcome Measure Information:
Title
FES cycle ergometry was performed for 8 sessions. Before and after exercise blood samples were collected and platelet aggregation and blood coagulation analysis were performed.
Time Frame
Before and after exercise (sessions 1 and 8), blood samples were collected.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nighat Kahn, PhD
Organizational Affiliation
VA Medical Center, Bronx
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Bronx
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.unitedspinal.org
Description
Click here for more information about this study: Effect of FES- Exercise on Hemostasis in Persons with Chronic Spinal Cord Injury

Learn more about this trial

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

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