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Developing Strategies to Optimize the Exercise Response After Tetraplegia.

Primary Purpose

Spinal Cord Injuries, Spinal Cord Injury Cervical, Paraplegia, Spinal

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HITT: intermittent high intensity exercise
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injuries focused on measuring exercise

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Spinal cord injury of at least one year duration, C5-T12, ASIA impairment scale (AIS) A-D
  • Aged 18-75 years for the duration of the study participation
  • Medically stable and healthy enough to engage in and complete exercise requirements
  • Willing and able to complete the exercise protocols and testing requirements
  • Able to understand and follow written and verbal instructions from study staff
  • Able to communicate with study staff about their exercise capabilities and preferences

Exclusion Criteria:

  • Current serious injury(ies) of the upper extremities
  • Known cardiovascular disease
  • Unsatisfactory results of EKG screening
  • Implanted electronic cardiac device (e.g. pace maker, defibrillator, etc.)
  • Current pressure ulcer(s)
  • Morbid obesity
  • Known thyroid dysfunction
  • Current cancer
  • Current uncontrolled high blood pressure ( > 140/90 mmHg)
  • Uncontrolled epilepsy
  • Current deep vein thrombosis
  • Ventilator-dependent
  • Cognitive impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Interspersing HITT in exercise

    Acute exercise bout with no HITT

    Arm Description

    We will test whether introducing HITT into an acute exercise bout will increase overall energy expenditure or time to fatigue.

    Exercise will occur at 50% peak without introducing HITT.

    Outcomes

    Primary Outcome Measures

    Energy expenditure in ml of oxygen consumed per minute per kg of body weight
    Estimation of energy expenditure for bout of exercise
    Time to fatigue
    Total duration of exercise

    Secondary Outcome Measures

    Ratings of perceived exertion
    Ratings of perceived exertion during exercise
    Heart rate
    We will examine differences in average, peak HR and HR variability

    Full Information

    First Posted
    July 7, 2020
    Last Updated
    May 11, 2021
    Sponsor
    University of Manitoba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04465825
    Brief Title
    Developing Strategies to Optimize the Exercise Response After Tetraplegia.
    Official Title
    Developing Strategies to Optimize the Exercise Response in Persons Living With Tetraplegia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    November 2021 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Manitoba

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To identify means to improve exercise performance in participants with tetraplegia.
    Detailed Description
    Part I. This study will examine the relationship between steady-state and peak exercise performance in participants with tetraplegia or paraplegia. Participants will have their peak energy expenditure measured using a discontinuous step test. Participants will then perform three different trials of exercise at a steady state at a target intensity that corresponds with 90%, 70%, and 60% of their own measured peak energy expense. Participants will exercise at the prescribed power output until fatigue. Participants may choose which exercise mode they use (with all steady-state trials being in the same mode as the peak test), and may choose to perform the study twice in the different exercise modes. Exercise trials will be performed over a number of different sessions in a randomized order, allowing for adequate rest and recovery between trials, and depending on each participant's capabilities and preferences. Part II. This study will determine if high intensity interval training (HIIT) results in greater energy expense than constant rate aerobic exercise, and will test if exercising with HITT effects time to fatigue. Participants will exercise using a high intensity interval training (HIIT) protocol, which involves alternating high intensity bouts of short duration with low intensity bouts of longer duration. Participants will have their peak energy expenditure measured using a discontinuous step test. Participants will then perform one trial of steady-state exercise at a target intensity that corresponds with 50% of their peak energy expense, for a target of 20-45 minutes. Participants will perform a separate trial using a HIIT protocol of exercise at a target intensity that corresponds with 50% of their peak energy expense interspersed with bouts of high intensity (target intensity that corresponds with 90% of peak energy expense) for 30-60 seconds, for a total duration target of 20-45 minutes. Participants may choose which exercise mode they use (with all trials being in the same mode as the peak test), and may choose to perform the study twice in the different exercise modes. Exercise trials will be performed over a number of different sessions in a randomized order, allowing for adequate rest and recovery between trials, and depending on each participant's capabilities and preferences.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries, Spinal Cord Injury Cervical, Paraplegia, Spinal
    Keywords
    exercise

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Part 2 is a randomized crossover design.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interspersing HITT in exercise
    Arm Type
    Active Comparator
    Arm Description
    We will test whether introducing HITT into an acute exercise bout will increase overall energy expenditure or time to fatigue.
    Arm Title
    Acute exercise bout with no HITT
    Arm Type
    No Intervention
    Arm Description
    Exercise will occur at 50% peak without introducing HITT.
    Intervention Type
    Behavioral
    Intervention Name(s)
    HITT: intermittent high intensity exercise
    Intervention Description
    Intermittent bouts of 30-60 seconds of exercise at 90% of peak intensity (HITT).
    Primary Outcome Measure Information:
    Title
    Energy expenditure in ml of oxygen consumed per minute per kg of body weight
    Description
    Estimation of energy expenditure for bout of exercise
    Time Frame
    Measured during 20-40 minutes of exercise
    Title
    Time to fatigue
    Description
    Total duration of exercise
    Time Frame
    Measured during 20-40 minutes of exercise
    Secondary Outcome Measure Information:
    Title
    Ratings of perceived exertion
    Description
    Ratings of perceived exertion during exercise
    Time Frame
    Measured during 20-40 minutes of exercise
    Title
    Heart rate
    Description
    We will examine differences in average, peak HR and HR variability
    Time Frame
    Measured during 20-40 minutes of exercise

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Spinal cord injury of at least one year duration, C5-T12, ASIA impairment scale (AIS) A-D Aged 18-75 years for the duration of the study participation Medically stable and healthy enough to engage in and complete exercise requirements Willing and able to complete the exercise protocols and testing requirements Able to understand and follow written and verbal instructions from study staff Able to communicate with study staff about their exercise capabilities and preferences Exclusion Criteria: Current serious injury(ies) of the upper extremities Known cardiovascular disease Unsatisfactory results of EKG screening Implanted electronic cardiac device (e.g. pace maker, defibrillator, etc.) Current pressure ulcer(s) Morbid obesity Known thyroid dysfunction Current cancer Current uncontrolled high blood pressure ( > 140/90 mmHg) Uncontrolled epilepsy Current deep vein thrombosis Ventilator-dependent Cognitive impairment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristine C Cowley, Ph.D.
    Phone
    2047893305
    Email
    kristine.cowley@umanitoba.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Once published we will strive to make anonymized study data available.
    IPD Sharing Time Frame
    The data will be available once published for one year.

    Learn more about this trial

    Developing Strategies to Optimize the Exercise Response After Tetraplegia.

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