Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury
NIV-Ex-CS
1 other identifier
interventional
15
1 country
1
Brief 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))
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 14, 2017
CompletedFirst Submitted
Initial submission to the registry
August 22, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedResults Posted
Study results publicly available
March 30, 2020
CompletedApril 9, 2020
March 1, 2020
1.6 years
August 22, 2017
January 30, 2020
March 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Peak Aerobic Capacity During FES-row Testing
Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
Day 0 and Day 2
Secondary Outcomes (3)
Change in Cardiac Output During FES-row Testing
Day 0 and Day 2
Change in Minute Ventilation During FES-row Testing
Day 0 and Day 2
Change in Tidal Volume During FES-row Testing
Day 0 and Day 2
Study Arms (2)
Non-invasive Ventilation(NIV)
ACTIVE COMPARATORSubjects will perform FES-row testing while receiving bi-level positive airway pressure ventilation applied through a full face-mask.
Sham Non-invasive ventilation(NIV)
SHAM COMPARATORSubjects will perform FES-row testing while receiving sham ventilation applied through a full face-mask.
Interventions
The ventilator will be 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.
The ventilator will be 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.
FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training
Eligibility Criteria
You may qualify if:
- Subjects aged 18 to 70 (IRB amendment to change maximal age from 60 to 70 years old approved on 9/20/17)
- Have had SCI (at neurological level C5-T12 with American Spinal Injury Association grade A or B or C)
- Medically stable
- Have FES-row trained for \>6 months
You may not qualify if:
- Hypertension(Blood pressure\>140/90 mmHg)
- Significant arrhythmias
- Coronary disease
- Chronic respiratory disease
- Diabetes
- Renal disease
- Cancer
- Epilepsy
- Current use of cardioactive medications
- Current grade 2 or greater pressure ulcers at relevant contact sites
- Other neurological disease
- Peripheral nerve compression or rotator cuff tears that limit the ability to row
- History of bleeding disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spaulding Hospital Cambridge
Cambridge, Massachusetts, 02138, United States
Related Publications (1)
Vivodtzev I, Picard G, Cepeda FX, Taylor JA. Acute Ventilatory Support During Whole-Body Hybrid Rowing in Patients With High-Level Spinal Cord Injury: A Randomized Controlled Crossover Trial. Chest. 2020 May;157(5):1230-1240. doi: 10.1016/j.chest.2019.10.044. Epub 2019 Nov 16.
PMID: 31738927DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The repeatability of maximal incremental exercise tests is difficult in Spinal cord injury, increasing the variability of the measure. Higher number of participants will be necessary to study the effect of NIV on the aerobic capacity.
Results Point of Contact
- Title
- Dr J. Andrew Taylor
- Organization
- Harvard Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
J. Andrew Taylor, PhD
Spaulding Rehabilitation Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigators and technicians helping for performing the test and encouraging the patient will be blind. Only one investigator will monitor the ventilation during the test and won't be blind but won't be participating to any encouragement or data acquisition.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
August 22, 2017
First Posted
August 30, 2017
Study Start
July 14, 2017
Primary Completion
February 1, 2019
Study Completion
April 1, 2019
Last Updated
April 9, 2020
Results First Posted
March 30, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share