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NCT02865343 · ClinicalTrials.gov registry record · NA
Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury
A NA study of Spinal Cord Injury, sponsored by Spaulding Rehabilitation Hospital.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT02865343: Completed NA study of Spinal Cord Injury, sponsored by Spaulding Rehabilitation Hospital.
NCT02865343 is a NA study of Spinal Cord Injury that has completed, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 11 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02865343, a NA study of Spinal Cord Injury, has completed, sponsored by Spaulding Rehabilitation Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 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 FES-RT for at least 6 months. Roughly half have high level SCI. Thirty individuals with high level SCI who have FES-row trained for at least 6 months will be randomized to (continued) FES-RT for 3 months with either NIV or sham NIV. Before and after training, the investigators will assess maximal aerobic capacity, ventilation, cardiac output, and arterio-venous oxygen difference. Based on the investigators current data, it is hypothesized that only those randomized to NIV will experience further increases in aerobic capacity and that these increases will relate to increases in cardiac output and arterio-venous oxygen difference. This Exploratory/Developmental Research project will lay the groundwork for a larger study of the impact of FES-RT+NIV to improve health and function in those with high level SCI.
Primary Outcome
Volunteers will perform a maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests in the Sham-NIV condition
Conditions Studied
Interventions
- DEVICE Sham Non-invasive ventilation(NIV)
- DEVICE Non-invasive Ventilation(NIV)
Study Locations (1)
Massachusetts
- Spaulding Hospital Cambridge - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-02-22 |
| Est. Completion | 2019-06-28 |
| Phase | NA |
What the finished NCT02865343 record still lists
NCT02865343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which Sham Non-invasive ventilation(NIV) is the first listed.
NCT02865343 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02865343 about?
NCT02865343 is a clinical study titled "Ventilatory Support to Improve Exercise Training in High Level 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 FES-RT for at least 6 months. Roughly half have high level SCI. Thirty individuals with high level SCI who have FES-row trained for at least 6 m...
What is the current status of trial NCT02865343?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2017-02-22. Estimated completion is 2019-06-28.
What conditions does trial NCT02865343 study?
This clinical trial studies the following conditions: Spinal Cord Injury.
What interventions are being tested in trial NCT02865343?
The interventions under investigation include: Sham Non-invasive ventilation(NIV) (DEVICE), Non-invasive Ventilation(NIV) (DEVICE).
Who is sponsoring clinical trial NCT02865343?
This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02865343 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02865343's enrollment target sits among peer trials
11 80th of 99 higher than 19 of 99 other Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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