<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03267212</url>
  </required_header>
  <id_info>
    <org_study_id>SpauldingRH-2</org_study_id>
    <nct_id>NCT03267212</nct_id>
  </id_info>
  <brief_title>Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury</brief_title>
  <acronym>NIV-Ex-CS</acronym>
  <official_title>Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spaulding Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spaulding Rehabilitation Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators have an existing exercise program (N&gt;70) with a unique population of&#xD;
      individuals with spinal cord injury (SCI) who have been enrolled in Functional Electrical&#xD;
      Stimulation - Rowing Training (FES-RT) for at least 6 months. Previous data in the laboratory&#xD;
      from this exercise platform has recently showed that respiratory restriction in SCI reduces&#xD;
      inspiratory capacity in direct relation to lesion level, and those with high level injuries&#xD;
      have the greatest compromise. As a result, the increase in ventilatory requirements with FES&#xD;
      training results in an imbalance between ventilatory capacity and greater whole body skeletal&#xD;
      muscle demand after FES rowing training. Hence, external ventilatory support could improve&#xD;
      the ability to exercise train and hence enhance the adaptations to chronic exercise in high&#xD;
      level SCI. If our hypothesis is correct, this indicates that maximal aerobic capacity in&#xD;
      these individuals exceeds maximal voluntary ventilation. It will be important to determine&#xD;
      however the consistency of this response and at what level of injury it is not observed. In&#xD;
      parallel of the study # NCT02865343, the investigators will recruit here a population of&#xD;
      subjects who have completed six months of FES-row exercise training across a range of SCI&#xD;
      level (C5-T12). Hence, the investigators will be able to determine the consistency of the&#xD;
      effect and the dependence of the effect on SCI level. Some of them with level &gt;T3 may also&#xD;
      enroll in training effect study with NIV or sham NIV (NCT02865343))&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regular aerobic exercise with sufficient intensity can improve overall health, however daily&#xD;
      energy expenditure is low in those with SCI, especially in those with high level lesions. The&#xD;
      investigators have developed Functional Electrical Stimulation Row Training (FESRT) that&#xD;
      couples volitional arm and electrically controlled leg exercise, increasing the active muscle&#xD;
      and resulting in benefits of large muscle mass exercise. Despite the potential for enhancing&#xD;
      aerobic capacity, those with high level lesions (C4 to T2) have a remaining obstacle to&#xD;
      attaining higher work capacities. They have the greatest pulmonary muscle denervation and our&#xD;
      preliminary work suggests this limits the aerobic capacity that can be achieved with FESRT.&#xD;
      External ventilatory support could improve the ability to reach higher level of peak&#xD;
      ventilation and hence enhance the ability to exercise in high level SCI. Therefore, the&#xD;
      investigators hypothesize that the use of NIV during FESRT will reduce ventilatory limits to&#xD;
      exercise, leading to increased aerobic capacity in high level SCI. The aims are to examine&#xD;
      the acute effect of NIV on FES-row VO2max in subjects with both high and low level SCI. The&#xD;
      investigators have access to a large (N&gt;70) and unique population of individuals with SCI who&#xD;
      have been enrolled in FESRT for at least 6 months. Roughly half have SCI between C4 and T2&#xD;
      and half with lower injury levels (&lt;T3). 15 individuals who have FES row trained for at least&#xD;
      6 months will perform FES-VO2max row tests on separate days with and without the use of NIV&#xD;
      to determine maximal aerobic capacity and ventilation. Both FES-VO2max Row tests will be&#xD;
      performed at least 48-hours apart. Both tests will be performed with the NIV set-up but with&#xD;
      and without use of the NIV support in a random order. The level of inspiratory pressure will&#xD;
      be individually set during a familiarization test. The investigators will assess maximal&#xD;
      aerobic capacity, minute ventilation, tidal volume and cardiac output during FES-rowing.&#xD;
      Based on current data, it is hypothesized that only those with higher level of injury (&gt; T3)&#xD;
      will experience further increases in aerobic capacity when using the NIV support. This&#xD;
      exploratory/developmental research project will determine feasibility and effectiveness of&#xD;
      this approach to exercise and will lay the groundwork for a larger, controlled trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2017</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Peak Aerobic Capacity During FES-row Testing</measure>
    <time_frame>Day 0 and Day 2</time_frame>
    <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Cardiac Output During FES-row Testing</measure>
    <time_frame>Day 0 and Day 2</time_frame>
    <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Minute Ventilation During FES-row Testing</measure>
    <time_frame>Day 0 and Day 2</time_frame>
    <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tidal Volume During FES-row Testing</measure>
    <time_frame>Day 0 and Day 2</time_frame>
    <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Non-invasive Ventilation(NIV)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will perform FES-row testing while receiving bi-level positive airway pressure ventilation applied through a full face-mask.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Non-invasive ventilation(NIV)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects will perform FES-row testing while receiving sham ventilation applied through a full face-mask.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-invasive ventilation(NIV)</intervention_name>
    <description>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.</description>
    <arm_group_label>Non-invasive Ventilation(NIV)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Non-invasive ventilation(NIV)</intervention_name>
    <description>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.</description>
    <arm_group_label>Sham Non-invasive ventilation(NIV)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional Electrical Stimulation Row Training (FESRT)</intervention_name>
    <description>FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training</description>
    <arm_group_label>Non-invasive Ventilation(NIV)</arm_group_label>
    <arm_group_label>Sham Non-invasive ventilation(NIV)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 18 to 70 (IRB amendment to change maximal age from 60 to 70 years old&#xD;
             approved on 9/20/17)&#xD;
&#xD;
          -  Have had SCI (at neurological level C5-T12 with American Spinal Injury Association&#xD;
             grade A or B or C)&#xD;
&#xD;
          -  Medically stable&#xD;
&#xD;
          -  Have FES-row trained for &gt;6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypertension(Blood pressure&gt;140/90 mmHg)&#xD;
&#xD;
          -  Significant arrhythmias&#xD;
&#xD;
          -  Coronary disease&#xD;
&#xD;
          -  Chronic respiratory disease&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Renal disease&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Current use of cardioactive medications&#xD;
&#xD;
          -  Current grade 2 or greater pressure ulcers at relevant contact sites&#xD;
&#xD;
          -  Other neurological disease&#xD;
&#xD;
          -  Peripheral nerve compression or rotator cuff tears that limit the ability to row&#xD;
&#xD;
          -  History of bleeding disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J. Andrew Taylor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spaulding Rehabilitation Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spaulding Hospital Cambridge</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <results_first_submitted>January 30, 2020</results_first_submitted>
  <results_first_submitted_qc>March 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 30, 2020</results_first_posted>
  <last_update_submitted>March 31, 2020</last_update_submitted>
  <last_update_submitted_qc>March 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spaulding Rehabilitation Hospital</investigator_affiliation>
    <investigator_full_name>J. Andrew Taylor</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Functional Electrical Stimulation (FES)-Rowing</keyword>
  <keyword>Ventilatory support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03267212/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03267212/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Non-invasive Ventilation First, Then Sham Ventilation</title>
          <description>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.&#xD;
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.&#xD;
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.&#xD;
Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training</description>
        </group>
        <group group_id="P2">
          <title>Sham Ventilation First, Then Non-invasive Ventilation</title>
          <description>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.&#xD;
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.&#xD;
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.&#xD;
Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6">Non-invasive ventilation</participants>
                <participants group_id="P2" count="9">&quot;First Intervention (1 day)&quot;, &quot;Washout (2 days)&quot;, and &quot;Second Intervention (1 day)&quot;</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>High SCI</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Low SCI</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout (Min 2 Days / Max 7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Fifteen participants with SCI of American Spinal Injury Association Grade A or B or C, aged 40 (21 - 70) years and with a BMI of 27.2 kg/m2 (18-37). All participants were Not Hispanic or Latino but one participant had an unknown ethnicity. All participants were white but one participant was Black or African American.</population>
      <group_list>
        <group group_id="B1">
          <title>Non-invasive Ventilation(NIV) vs. Sham Ventilation</title>
          <description>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.&#xD;
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.&#xD;
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.&#xD;
Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40" lower_limit="21" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>Kg/m2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27" lower_limit="18" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Peak Aerobic Capacity During FES-row Testing</title>
        <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
        <time_frame>Day 0 and Day 2</time_frame>
        <population>10 subjects completed both NIV and Sham tests</population>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Ventilation</title>
            <description>Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support</description>
          </group>
          <group group_id="O2">
            <title>Sham Ventilation</title>
            <description>Volunteers performed a maximal FES-row tests with Sham-NIV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peak Aerobic Capacity During FES-row Testing</title>
          <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
          <population>10 subjects completed both NIV and Sham tests</population>
          <units>L/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.83" spread="0.76"/>
                    <measurement group_id="O2" value="1.82" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cardiac Output During FES-row Testing</title>
        <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
        <time_frame>Day 0 and Day 2</time_frame>
        <population>Due to technical issues, only one participant could perform both tests (NIV and sham) for this outcome</population>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Ventilation</title>
            <description>Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support</description>
          </group>
          <group group_id="O2">
            <title>Sham Ventilation</title>
            <description>Volunteers performed a maximal FES-row tests with Sham-NIV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cardiac Output During FES-row Testing</title>
          <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
          <population>Due to technical issues, only one participant could perform both tests (NIV and sham) for this outcome</population>
          <units>L/min</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                    <measurement group_id="O2" value="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Minute Ventilation During FES-row Testing</title>
        <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
        <time_frame>Day 0 and Day 2</time_frame>
        <population>Participants who completed both NIV and sham tests</population>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Ventilation</title>
            <description>Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support</description>
          </group>
          <group group_id="O2">
            <title>Sham Ventilation</title>
            <description>Volunteers performed a maximal FES-row tests with Sham-NIV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Minute Ventilation During FES-row Testing</title>
          <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
          <population>Participants who completed both NIV and sham tests</population>
          <units>L/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.8" spread="9.6"/>
                    <measurement group_id="O2" value="40.3" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Tidal Volume During FES-row Testing</title>
        <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
        <time_frame>Day 0 and Day 2</time_frame>
        <population>Participants who completed both NIV and sham tests</population>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Ventilation</title>
            <description>Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support</description>
          </group>
          <group group_id="O2">
            <title>Sham Ventilation</title>
            <description>Volunteers performed a maximal FES-row tests with Sham-NIV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Tidal Volume During FES-row Testing</title>
          <description>Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV</description>
          <population>Participants who completed both NIV and sham tests</population>
          <units>L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="0.3"/>
                    <measurement group_id="O2" value="1.4" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>20 months</time_frame>
      <desc>This study was investigating the effect of an additional tool to help respiratory function during a single session of exercise. Adverse events has been collected during the whole period of the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Non-invasive Ventilation</title>
          <description>Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support</description>
        </group>
        <group group_id="E2">
          <title>Sham Ventilation</title>
          <description>Volunteers performed a maximal FES-row tests with Sham-NIV</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <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.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr J. Andrew Taylor</name_or_title>
      <organization>Harvard Medical School</organization>
      <phone>6177585503</phone>
      <email>jandrew_taylor@hms.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03267212
org study id: SpauldingRH-2
nct id: NCT03267212
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
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))
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. The
      investigators 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 reach higher level of peak
      ventilation and hence enhance the ability to exercise in high level SCI. 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. The aims are to examine
      the acute effect of NIV on FES-row VO2max in subjects with both high and low level SCI. 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
      and half with lower injury levels (<T3). 15 individuals who have FES row trained for at least
      6 months will perform FES-VO2max row tests on separate days with and without the use of NIV
      to determine maximal aerobic capacity and ventilation. Both FES-VO2max Row tests will be
      performed at least 48-hours apart. Both tests will be performed with the NIV set-up but with
      and without use of the NIV support in a random order. The level of inspiratory pressure will
      be individually set during a familiarization test. The investigators will assess maximal
      aerobic capacity, minute ventilation, tidal volume and cardiac output during FES-rowing.
      Based on current data, it is hypothesized that only those with higher level of injury (> T3)
      will experience further increases in aerobic capacity when using the NIV support. 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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: 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.
measure: Change in Peak Aerobic Capacity During FES-row Testing
time frame: Day 0 and Day 2
description: Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
measure: Change in Cardiac Output During FES-row Testing
time frame: Day 0 and Day 2
description: Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
measure: Change in Minute Ventilation During FES-row Testing
time frame: Day 0 and Day 2
description: Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
measure: Change in Tidal Volume During FES-row Testing
time frame: Day 0 and Day 2
description: Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
arm group label: Non-invasive Ventilation(NIV)
arm group type: Active Comparator
description: Subjects will perform FES-row testing while receiving bi-level positive airway pressure ventilation applied through a full face-mask.
arm group label: Sham Non-invasive ventilation(NIV)
arm group type: Sham Comparator
description: Subjects will perform FES-row testing while receiving sham ventilation applied through a full face-mask.
intervention type: Device
intervention name: Non-invasive ventilation(NIV)
description: 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.
arm group label: Non-invasive Ventilation(NIV)
intervention type: Device
intervention name: Sham Non-invasive ventilation(NIV)
description: 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.
arm group label: Sham Non-invasive ventilation(NIV)
intervention type: Other
intervention name: Functional Electrical Stimulation Row Training (FESRT)
description: FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training
arm group label: Non-invasive Ventilation(NIV)
arm group label: Sham Non-invasive ventilation(NIV)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: J. Andrew Taylor, PhD
role: Principal Investigator
affiliation: Spaulding Rehabilitation Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Spaulding Rehabilitation Hospital
investigator full name: J. Andrew Taylor
investigator title: Principle Investigator
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
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.
point of contact: 