Clinical trial NCT00223912: Effect of Exercise on Blood Coagulation in Persons With Chronic Spinal Cord Injury
Official title: Effect of FES- Exercise on Hemostasis in Persons With Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Spinal Cord Injury
Keywords: Cardiovascular Disease
Exercise
Functional electrical stimulation
hemostasis
Spinal cord injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-09-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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:

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

Primary outcomes:
measure: 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.
timeFrame: Before and after exercise (sessions 1 and 8), blood samples were collected.
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: VA Medical Center, Bronx
state: New York
Study officials:
affiliation: VA Medical Center, Bronx
name: Nighat Kahn, PhD
role: PRINCIPAL_INVESTIGATOR
References: