Cardiovascular DiseaseFESNCT00223912
Effect of Exercise on Blood Coagulation in Persons With Chronic Spinal Cord Injury
A study testing ERGYS BikeFunctional Electrical Stimulation Ergometry in people with Cardiovascular Disease and Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Disease, Spinal Cord Injury
- What is being tested?
- ERGYS BikeFunctional Electrical Stimulation Ergometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of FES- Exercise on Hemostasis 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.
Read the 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.
- Conditions
- Cardiovascular Disease, Spinal Cord Injury
- Being tested
- ERGYS BikeFunctional Electrical Stimulation Ergometry
- Keywords
- Cardiovascular Disease, Exercise, Functional electrical stimulation, hemostasis, Spinal cord injury
- Medical subject headings
- Cardiovascular Diseases, Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERGYS BikeFunctional Electrical Stimulation ErgometryDevice
A
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Lower-extremity functional electrical stimulation Receives: Device: ERGYS BikeFunctional Electrical Stimulation Ergometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after exercise (sessions 1 and 8), blood samples were collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Nighat Kahn, PhD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223912
- Sponsor's protocol ID
- B3168P
- Other IDs
- 1124-03-0010, MIRB#_00514
- Acronym
- FES
- Status last verified
- Sep 2010
- First submitted
- 14 Sep 2005
- Last updated
- 16 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of FES- Exercise on Hemostasis in Persons With Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00223912
- Acronym / sponsor ID
- FES / B3168P
- Conditions
- Cardiovascular Disease, Spinal Cord Injury
- Keywords
- Cardiovascular Disease, Exercise, Functional electrical stimulation, hemostasis, Spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: ERGYS BikeFunctional Electrical Stimulation ErgometryLower-extremity functional electrical stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERGYS BikeFunctional Electrical Stimulation ErgometryA | Device | 1 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2010.
- Click here for more information about this study: Effect of FES- Exercise on Hemostasis in Persons with Chronic Spinal Cord InjuryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nighat Kahn, PhD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERGYS BikeFunctional Electrical Stimulation Ergometry in people with Cardiovascular Disease and Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Before and after exercise (sessions 1 and 8), blood samples were collected.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2010.