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

Cardiovascular Disease Clinical Trial

— FES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223912
• Other study ID #: B3168P
• Secondary ID: 1124-03-0010MIRB
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: September 15, 2010
• Start date: November 2003
• Est. completion date: December 2006

Study information

• Verified date: September 2010
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• ERGYS BikeFunctional Electrical Stimulation Ergometry
A

Locations

Country	Name	City	State
United States	VA Medical Center, Bronx	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Before and after exercise (sessions 1 and 8), blood samples were collected.	No

External Links

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