Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223912
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 16, 2010
Sponsor:
Information provided by:
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Spinal Cord Injury Device: ERGYS BikeFunctional Electrical Stimulation Ergometry Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of FES- Exercise on Hemostasis in Persons With Chronic Spinal Cord Injury
Study Start Date : November 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
1
Lower-extremity functional electrical stimulation
Device: ERGYS BikeFunctional Electrical Stimulation Ergometry
A




Primary Outcome Measures :
  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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223912


Locations
Layout table for location information
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
Layout table for investigator information
Principal Investigator: Nighat Kahn, PhD VA Medical Center, Bronx
Additional Information:
Layout table for additonal information
Responsible Party: Kahn, Nighat - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00223912    
Other Study ID Numbers: B3168P
1124-03-0010
MIRB#_00514
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: September 2010
Keywords provided by VA Office of Research and Development:
Cardiovascular Disease
Exercise
Functional electrical stimulation
hemostasis
Spinal cord injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Cardiovascular Diseases
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System