Spinal Cord InjuryNIV-ExNCT02865343
Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury
A study testing Non-invasive Ventilation(NIV) in people with Spinal Cord Injury, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Non-invasive Ventilation(NIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects aged 18 to 60
- Have had high level SCI (neurological level ≥T3 with American Spinal Injury Association grade A or B or C)
- Medically stable
- Have FES-row trained for >6 months
Who cannot join
- Hypertension(Blood pressure>140/90 mmHg)
- Significant arrhythmias
- Coronary disease
- Chronic respiratory disease
- Diabetes
- Renal disease
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Hospital Cambridge
Cambridge, Massachusetts, 02138
About this study
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.
Read the detailed description
Regular aerobic exercise with sufficient intensity can improve overall health, however daily energy expenditure is low in those with SCI, especially in those with high level lesions. We have developed Functional Electrical Stimulation Row Training (FESRT) that couples volitional arm and electrically controlled leg exercise, increasing the active muscle and resulting in benefits of large muscle mass exercise. Despite the potential for enhancing aerobic capacity, those with high level lesions (C4 to T2) have a remaining obstacle to attaining higher work capacities they have the greatest pulmonary muscle denervation and our preliminary work suggests this limits the aerobic capacity that can be achieved with FESRT. External ventilatory support could improve the ability to exercise train and hence enhance the adaptations to chronic exercise in high level SCI. Non invasive ventilation (NIV) during exercise training has been shown to improve gains in exercise capacity in those with similarly restrictive breathing. Therefore, the investigators hypothesize that the use of NIV during FESRT will reduce ventilatory limits to exercise, leading to increased aerobic capacity in high level SCI. Our aims are to determine the magnitude of improvement in aerobic capacity and its relationship to increases in maximal cardiac output and arterio venous oxygen difference after 3 months of FESRT+NIV compared to FESRT+shamNIV. The investigators have access to a large (N>70) and unique population of individuals with SCI who have been enrolled in FESRT for at least 6 months. Roughly half have SCI between C4 and T2. 30 individuals with high level SCI who have FES row trained for at least 6 months will be randomized to (continued) FESRT 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 our 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 increased cardiac output and arterio venous oxygen difference. This Exploratory/Developmental Research project will determine feasibility and effectiveness of this approach to exercise and will lay the groundwork for a larger, controlled trial.
- Conditions
- Spinal Cord Injury
- Being tested
- Non-invasive Ventilation(NIV), Sham Non-invasive ventilation(NIV)
- Keywords
- Functional Electrical Stimulation (FES)-Rowing
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Ventilation(NIV)Device
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.
Sham Non-invasive ventilation(NIV)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Ventilation(NIV) | Active comparator | Subjects randomized to NIV will perform 12-weeks of FES-row training while receiving bi-level positive airway pressure ventilation applied through a full face-mask. Receives: Device: Non-invasive Ventilation(NIV) |
| Sham Non-invasive ventilation(NIV) | Placebo comparator | Subjects randomized to Sham-NIV will perform 12-weeks of FES-row training while receiving sham ventilation applied through a full face-mask. Receives: Device: Sham Non-invasive ventilation(NIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline Aerobic Capacity After 3 Months of FES-row Training.
Volunteers will perform a maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests in the Sham-NIV condition
Measured: Baseline and 3 months
Secondary outcomes (2)
Change in Peak Cardiac Output After 3 Months of FES-row Training.
Volunteers will perform a maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests in the Sham-NIV condition
Measured: Baseline and 3 months
Change in Baseline Peak Minute Ventilation During Exercise After 3 Months of FES-row Training
Volunteers will perform a maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests in the Sham-NIV condition
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start22 Feb 2017
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Andrew Taylor, Spaulding Rehabilitation Hospital
- Investigators
- J. Andrew Taylor, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865343
- Sponsor's protocol ID
- 2016P000658
- Acronym
- NIV-Ex
- Status last verified
- Feb 2023
- First submitted
- 15 Jul 2016
- Last updated
- 9 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31738927
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02865343
- Acronym / sponsor ID
- NIV-Ex / 2016P000658
- Conditions
- Spinal Cord Injury
- Keywords
- Functional Electrical Stimulation (FES)-Rowing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 30 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Regular aerobic exercise with sufficient intensity can improve overall health, however daily energy expenditure is low in those with SCI, especially in those with high level lesions. We have developed Functional Electrical Stimulation Row Training (FESRT) that couples volitional arm and electrically controlled leg exercise, increasing the active muscle and resulting in benefits of large muscle mass exercise. Despite the potential for enhancing aerobic capacity, those with high level lesions (C4 to T2) have a remaining obstacle to attaining higher work capacities they have the greatest pulmonary muscle denervation and our preliminary work suggests this limits the aerobic capacity that can be achieved with FESRT. External ventilatory support could improve the ability to exercise train and hence enhance the adaptations to chronic exercise in high level SCI. Non invasive ventilation (NIV) during exercise training has been shown to improve gains in exercise capacity in those with similarly restrictive breathing. Therefore, the investigators hypothesize that the use of NIV during FESRT will reduce ventilatory limits to exercise, leading to increased aerobic capacity in high level SCI. Our aims are to determine the magnitude of improvement in aerobic capacity and its relationship to increases in maximal cardiac output and arterio venous oxygen difference after 3 months of FESRT+NIV compared to FESRT+shamNIV. The investigators have access to a large (N>70) and unique population of individuals with SCI who have been enrolled in FESRT for at least 6 months. Roughly half have SCI between C4 and T2. 30 individuals with high level SCI who have FES row trained for at least 6 months will be randomized to (continued) FESRT 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 our 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 increased cardiac output and arterio venous oxygen difference. This Exploratory/Developmental Research project will determine feasibility and effectiveness of this approach to exercise and will lay the groundwork for a larger, controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Ventilation(NIV) | Active comparator | Device: Non-invasive Ventilation(NIV)Subjects randomized to NIV will perform 12-weeks of FES-row training while receiving bi-level positive airway pressure ventilation applied through a full face-mask. |
| Sham Non-invasive ventilation(NIV) | Placebo comparator | Device: Sham Non-invasive ventilation(NIV)Subjects randomized to Sham-NIV will perform 12-weeks of FES-row training while receiving sham ventilation applied through a full face-mask. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects aged 18 to 60
- Have had high level SCI (neurological level ≥T3 with American Spinal Injury Association grade A or B or C)
- Medically stable
- Have FES-row trained for >6 months
Key exclusion criteria (13 listed)
- Hypertension(Blood pressure>140/90 mmHg)
- Significant arrhythmias
- Coronary disease
- Chronic respiratory disease
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive Ventilation(NIV)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. | Device | Non-invasive Ventilation(NIV) |
| Sham Non-invasive ventilation(NIV)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. | Device | Sham Non-invasive ventilation(NIV) |
Primary outcome
Change in Baseline Aerobic Capacity After 3 Months of FES-row Training.
Time frame: Baseline and 3 months
Volunteers will perform a maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests in the Sham-NIV condition
2 secondary outcomes
Change in Peak Cardiac Output After 3 Months of FES-row Training.
Time frame: Baseline and 3 months
Change in Baseline Peak Minute Ventilation During Exercise After 3 Months of FES-row Training
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31738927Vivodtzev 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Andrew Taylor, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Ventilation(NIV) in people with Spinal Cord Injury, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Baseline Aerobic Capacity After 3 Months of FES-row Training. (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.