NCT00223912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

September 16, 2010

Status Verified

September 1, 2010

Enrollment Period

3.1 years

First QC Date

September 14, 2005

Last Update Submit

September 15, 2010

Conditions

Cardiovascular DiseaseSpinal Cord Injury

Keywords

Cardiovascular DiseaseExerciseFunctional electrical stimulationhemostasisSpinal cord injury

Outcome Measures

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.

    Before and after exercise (sessions 1 and 8), blood samples were collected.

Study Arms (1)

1

OTHER

Lower-extremity functional electrical stimulation

Device: ERGYS BikeFunctional Electrical Stimulation Ergometry

Interventions

ERGYS BikeFunctional Electrical Stimulation ErgometryDEVICE

A

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesSpinal Cord InjuriesMotor Activity

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBehavior

Study Officials

  • Nighat Kahn, PhD

    VA Medical Center, Bronx

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

November 1, 2003

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

September 16, 2010

Record last verified: 2010-09

Locations

US(1)