Trial Outcomes & Findings for Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury (NCT NCT03267212)
NCT ID: NCT03267212
Last Updated: 2020-04-09
Results Overview
Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Day 0 and Day 2
Results posted on
2020-04-09
Participant Flow
Participant milestones
| Measure |
Non-invasive Ventilation First, Then Sham Ventilation
All subjects performed FES-row testing while receiving bi-level positive airway pressure ventilation first and then Sham ventilation applied through a full face-mask.
Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
Sham Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training
|
Sham Ventilation First, Then Non-invasive Ventilation
All subjects performed FES-row testing while receiving Sham bi-level positive airway pressure ventilation first and then true ventilation applied through a full face-mask.
Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
Sham Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training
|
|---|---|---|
|
First Intervention
STARTED
|
6
|
9
|
|
First Intervention
High SCI
|
2
|
5
|
|
First Intervention
Low SCI
|
4
|
4
|
|
First Intervention
COMPLETED
|
5
|
6
|
|
First Intervention
NOT COMPLETED
|
1
|
3
|
|
Washout (Min 2 Days / Max 7 Days)
STARTED
|
5
|
6
|
|
Washout (Min 2 Days / Max 7 Days)
COMPLETED
|
4
|
6
|
|
Washout (Min 2 Days / Max 7 Days)
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
4
|
6
|
|
Second Intervention
COMPLETED
|
4
|
6
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Non-invasive Ventilation First, Then Sham Ventilation
All subjects performed FES-row testing while receiving bi-level positive airway pressure ventilation first and then Sham ventilation applied through a full face-mask.
Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
Sham Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training
|
Sham Ventilation First, Then Non-invasive Ventilation
All subjects performed FES-row testing while receiving Sham bi-level positive airway pressure ventilation first and then true ventilation applied through a full face-mask.
Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
Sham Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training
|
|---|---|---|
|
First Intervention
Lost to Follow-up
|
0
|
2
|
|
First Intervention
Withdrawal by Subject
|
1
|
1
|
|
Washout (Min 2 Days / Max 7 Days)
Physician Decision
|
1
|
0
|
Baseline Characteristics
Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Non-invasive Ventilation(NIV) vs. Sham Ventilation
n=15 Participants
All subjects performed FES-row testing while receiving bi-level positive airway pressure ventilation (or Sham ventilation) applied through a full face-mask. The tests were performed in a random order.
Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
Sham Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
40 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
|
Body Mass Index
|
27 Kg/m2
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 2Population: 10 subjects completed both NIV and Sham tests
Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
Outcome measures
| Measure |
Non-invasive Ventilation
n=10 Participants
Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support
|
Sham Ventilation
n=10 Participants
Volunteers performed a maximal FES-row tests with Sham-NIV
|
|---|---|---|
|
Change in Peak Aerobic Capacity During FES-row Testing
|
1.83 L/min
Standard Deviation 0.76
|
1.82 L/min
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Day 0 and Day 2Population: Due to technical issues, only one participant could perform both tests (NIV and sham) for this outcome
Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
Outcome measures
| Measure |
Non-invasive Ventilation
n=1 Participants
Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support
|
Sham Ventilation
n=1 Participants
Volunteers performed a maximal FES-row tests with Sham-NIV
|
|---|---|---|
|
Change in Cardiac Output During FES-row Testing
|
9.6 L/min
|
10.3 L/min
|
SECONDARY outcome
Timeframe: Day 0 and Day 2Population: Participants who completed both NIV and sham tests
Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
Outcome measures
| Measure |
Non-invasive Ventilation
n=10 Participants
Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support
|
Sham Ventilation
n=10 Participants
Volunteers performed a maximal FES-row tests with Sham-NIV
|
|---|---|---|
|
Change in Minute Ventilation During FES-row Testing
|
38.8 L/min
Standard Deviation 9.6
|
40.3 L/min
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Day 0 and Day 2Population: Participants who completed both NIV and sham tests
Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
Outcome measures
| Measure |
Non-invasive Ventilation
n=10 Participants
Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support
|
Sham Ventilation
n=10 Participants
Volunteers performed a maximal FES-row tests with Sham-NIV
|
|---|---|---|
|
Change in Tidal Volume During FES-row Testing
|
1.6 L
Standard Error 0.3
|
1.4 L
Standard Error 0.3
|
Adverse Events
Non-invasive Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place