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Completed

NCT Number: NCT00223912

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERGYS BikeFunctional Electrical Stimulation Ergometry

Device

A

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

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

Acronym: FES

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Sep 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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