Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Developing Strategies to Optimize the Exercise Response After Tetraplegia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04465825
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

Brief Summary:
To identify means to improve exercise performance in participants with tetraplegia.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Spinal Cord Injury Cervical Paraplegia, Spinal Behavioral: HITT: intermittent high intensity exercise Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Part 2 is a randomized crossover design.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Developing Strategies to Optimize the Exercise Response in Persons Living With Tetraplegia.
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Interspersing HITT in exercise
We will test whether introducing HITT into an acute exercise bout will increase overall energy expenditure or time to fatigue.
Behavioral: HITT: intermittent high intensity exercise
Intermittent bouts of 30-60 seconds of exercise at 90% of peak intensity (HITT).

No Intervention: Acute exercise bout with no HITT
Exercise will occur at 50% peak without introducing HITT.



Primary Outcome Measures :
  1. Energy expenditure [ Time Frame: Measured during 20-40 minutes of exercise ]
    Estimation of energy expenditure for bout of exercise

  2. Time to fatigue [ Time Frame: Measured during 20-40 minutes of exercise ]
    Total duration of exercise


Secondary Outcome Measures :
  1. Ratings of perceived exertion [ Time Frame: Measured during 20-40 minutes of exercise ]
    Ratings of perceived exertion during exercise

  2. Heart rate [ Time Frame: Measured during 20-40 minutes of exercise ]
    We will examine differences in average, peak HR and HR variability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465825


Contacts
Layout table for location contacts
Contact: Kristine C Cowley, Ph.D. 2047893305 kristine.cowley@umanitoba.ca

Sponsors and Collaborators
University of Manitoba
Layout table for additonal information
Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT04465825    
Other Study ID Numbers: HS22987
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once published we will strive to make anonymized study data available.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: The data will be available once published for one year.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Manitoba:
exercise
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Quadriplegia
Paraplegia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations
Signs and Symptoms