Developing Strategies to Optimize the Exercise Response After Tetraplegia.

Developing Strategies to Optimize the Exercise Response in Persons Living With Tetraplegia.

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

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries; Spinal Cord Injury Cervical; Paraplegia, Spinal
• Intervention / Treatment: Behavioral: HITT: intermittent high intensity exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristine C Cowley, Ph.D.; Phone Number: 2047893305; Email: kristine.cowley@umanitoba.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy expenditure in ml of oxygen consumed per minute per kg of body weight	Estimation of energy expenditure for bout of exercise	Measured during 20-40 minutes of exercise
Time to fatigue	Total duration of exercise	Measured during 20-40 minutes of exercise

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratings of perceived exertion	Ratings of perceived exertion during exercise	Measured during 20-40 minutes of exercise
Heart rate	We will examine differences in average, peak HR and HR variability	Measured during 20-40 minutes of exercise

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: exercise
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Wounds and Injuries; Spinal Cord Injuries; Quadriplegia; Paraplegia
• Other Study ID Numbers: HS22987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No