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
About this trial
This is an interventional basic science trial for Spinal Cord Injuries focused on measuring exercise
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
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
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.
We'll reach out to this number within 24 hrs