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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: Completed NA study of Spinal Cord Injury, sponsored by Spaulding Rehabilitation Hospital.

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. According to ClinicalTrials.gov, the official US trial registry.

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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))

Primary Outcome

Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV

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

FieldValue
Enrollment Target 15 participants
Start Date 2017-07-14
Est. Completion 2019-04-01
Phase NA
Spaulding Rehabilitation Hospital

101 total trials

What the finished NCT03267212 record still lists

NCT03267212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (83% lower).

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 a single indexed study location in 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.

Similar trials for Spinal Cord Injury

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03267212's enrollment target sits among peer trials

15 68th of 99 higher than 28 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03267212, the US trial registry maintained by the National Library of Medicine. NCT03267212 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.