Developing Strategies to Optimize the Exercise Response After Tetraplegia.

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04465825
• Other study ID #: HS22987
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: University of Manitoba
• Contact: Kristine C Cowley, Ph.D.
• Phone: 2047893305
• Email: kristine.cowley[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Paraplegia
• Paraplegia, Spinal
• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury Cervical
• Wounds and Injuries

Intervention

Behavioral:
• HITT: intermittent high intensity exercise
Intermittent bouts of 30-60 seconds of exercise at 90% of peak intensity (HITT).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time to fatigue	Total duration of exercise	Measured during 20-40 minutes of exercise
Secondary	Ratings of perceived exertion	Ratings of perceived exertion during exercise	Measured during 20-40 minutes of exercise
Secondary	Heart rate	We will examine differences in average, peak HR and HR variability	Measured during 20-40 minutes of exercise