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NCT03267212 · ClinicalTrials.gov registry record · NA
Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury
A NA study of Spinal Cord Injury, sponsored by Spaulding Rehabilitation Hospital.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03267212 is a NA study of Spinal Cord Injury that has completed, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 15 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03267212, a NA study of Spinal Cord Injury, has completed, sponsored by Spaulding Rehabilitation Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators have an existing exercise program (N\>70) with a unique population of individuals with spinal cord injury (SCI) who have been enrolled in Functional Electrical Stimulation - Rowing Training (FES-RT) for at least 6 months. Previous data in the laboratory from this exercise platform has recently showed that respiratory restriction in SCI reduces inspiratory capacity in direct relation to lesion level, and those with high level injuries have the greatest compromise. As a result, the increase in ventilatory requirements with FES training results in an imbalance between ventilatory capacity and greater whole body skeletal muscle demand after FES rowing training. Hence, external ventilatory support could improve the ability to exercise train and hence enhance the adaptations to chronic exercise in high level SCI. If our hypothesis is correct, this indicates that maximal aerobic capacity in these individuals exceeds maximal voluntary ventilation. It will be important to determine however the consistency of this response and at what level of injury it is not observed. In parallel of the study # NCT02865343, the investigators will recruit here a population of subjects who have completed six months of FES-row exercise training across a range of SCI level (C5-T12). Hence, the investigators will be able to determine the consistency of the effect and the dependence of the effect on SCI level. Some of them with level \>T3 may also enroll in training effect study with NIV or sham NIV (NCT02865343))
Conditions Studied
Interventions
- OTHER Functional Electrical Stimulation Row Training (FESRT)
- DEVICE Non-invasive ventilation(NIV)
- DEVICE Sham Non-invasive ventilation(NIV)
Study Locations (1)
Massachusetts
- Spaulding Hospital Cambridge - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-07-14 |
| Est. Completion | 2019-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03267212
The ClinicalTrials.gov registry entry for NCT03267212 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (83% lower). The listed sponsor is Spaulding Rehabilitation Hospital, which has 101 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 3 interventions - of which Functional Electrical Stimulation Row Training (FESRT) is the first listed.
NCT03267212 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03267212 about?
NCT03267212 is a clinical study titled "Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury". The investigators have an existing exercise program (N\>70) with a unique population of individuals with spinal cord injury (SCI) who have been enrolled in Functional Electrical Stimulation - Rowing Training (FES-RT) for at least 6 months. Previous data in the laboratory from this exercise platform ...
What is the current status of trial NCT03267212?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2017-07-14. Estimated completion is 2019-04-01.
What conditions does trial NCT03267212 study?
This clinical trial studies the following conditions: Spinal Cord Injury.
What interventions are being tested in trial NCT03267212?
The interventions under investigation include: Functional Electrical Stimulation Row Training (FESRT) (OTHER), Non-invasive ventilation(NIV) (DEVICE), Sham Non-invasive ventilation(NIV) (DEVICE).
Who is sponsoring clinical trial NCT03267212?
This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03267212 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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