Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI
Public ClinicalTrials.gov record NCT02139436. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 results that clearly delineate potential health benefits of FES-RT, and if FES-RT is effective in a majority of those with SCI, its application, implementation, and integration could be easily replicated.
Study identification
- NCT ID
- NCT02139436
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 68 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 20 Years to 40 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2013
- Primary completion
- Feb 29, 2020
- Completion
- Feb 28, 2021
- Last update posted
- Mar 21, 2022
2013 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spaulding Hospital Cambridge | Cambridge | Massachusetts | 02138 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02139436, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2022 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02139436 live on ClinicalTrials.gov.