Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury

NCT02865343 | Completed Results FDA Device

• 1 other identifier: 2016P000658
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 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 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.

Conditions

Spinal Cord Injury

Keywords

Functional Electrical Stimulation (FES)-Rowing

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 3 months

Secondary Outcomes (2)

• Change in Peak Cardiac Output After 3 Months of FES-row Training.

  Baseline and 3 months

• Change in Baseline Peak Minute Ventilation During Exercise After 3 Months of FES-row Training

  Baseline and 3 months

Study Arms (2)

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.

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.

Device: Sham Non-invasive ventilation(NIV)

Interventions

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.

Non-invasive Ventilation(NIV)

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.

Sham Non-invasive ventilation(NIV)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Hospital Cambridge

Cambridge, Massachusetts, 02138, United States

Location

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: 31738927 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Limitations and Caveats

The repeatability of maximal exercise tests is difficult in Spinal cord injury, increasing variability of measures an limiting data availability. 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

jandrew_taylor@hms.harvard.edu

6177585503

Study Officials

• J. Andrew Taylor, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: August 12, 2016
• Study Start: February 22, 2017
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: February 9, 2023
• Results First Posted: July 30, 2020

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)