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NCT02139436 · ClinicalTrials.gov registry record · NA
Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI
A NA study, sponsored by Spaulding Rehabilitation Hospital.
- Completed
- Registry status
- NA
- Development phase
- 68
- Enrollment target
NCT02139436 is a NA study that has completed, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 68 participants.
The verdict
NCT02139436, a NA study, has completed, sponsored by Spaulding Rehabilitation Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 68 participants
- Enrollment target
Study Summary
Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year, there are profound declines in physiologic function, forming the underlying substrate for future cardiovascular disease . In fact, acquired cardiovascular disease is an increasingly recognized consequence of SCI and is the leading cause of death in SCI. Though incompletely understood, the almost 10-fold prevalence of cardiovascular disease results in part from profound physiologic 'detraining' resulting from motor impairment and immobility. Currently, effective interventions preventing acute declines that lead to cardiovascular compromise and increased risk in SCI are lacking - exercise therapy for those with SCI is challenging and when employed, is typically limited to the upper body. Recently, the investigators refined a unique form of exercise for those with SCI that specifically mirrors exercise performed by those without SCI. Functional Electrical Stimulation (FES) Row Training (RT) couples volitional arm and electrically controlled leg exercise, resulting in a hemodynamic profile that produces the beneficial cardiac loading conditions of large muscle mass exercise. As such, FES-RT may be a safe and effective way to attenuate cardiovascular declines following SCI. The investigators aims are to test the overall hypotheses that FES-RT will: 1) mitigate against increased visceral adiposity and reduced insulin sensitivity, 2) prevent worsening lipid profile and compromised baroreflex function, and 3) counter ventricular wall thickening and declining ventricular function occurring with acute SCI, and that these effects will be greater than that observed with an arms-only exercise group. Changes with FES-RT will be compared to a time (wait-list) control and to arms-only-RT. Individuals with an SCI within the last 3-6 months will be randomized to FES-RT, to a time control, or arms-only-RT. Measures will be made at baseline and 6 months. The investigators work will provide res
Interventions
- OTHER FES-row-training
- OTHER Arms-only-row training
- OTHER Time Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2013-12 |
| Est. Completion | 2021-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02139436
The ClinicalTrials.gov registry entry for NCT02139436 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spaulding Rehabilitation Hospital, which has 101 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which FES-row-training is the first listed.
NCT02139436 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02139436 about?
NCT02139436 is a clinical study titled "Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI". Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year, there are profound declines in physiologic function, forming the underlying substrate for future cardiovascular disease . In fact, acquired cardiovascular disease is an increasingly recognized consequence o...
What is the current status of trial NCT02139436?
This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2013-12. Estimated completion is 2021-03-01.
What interventions are being tested in trial NCT02139436?
The interventions under investigation include: FES-row-training (OTHER), Arms-only-row training (OTHER), Time Control (OTHER).
Who is sponsoring clinical trial NCT02139436?
This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.
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