Clinical trial NCT04465825: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Injury Cervical
Paraplegia, Spinal
Keywords: exercise
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Part 2 is a randomized crossover design.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Energy expenditure in ml of oxygen consumed per minute per kg of body weight
timeFrame: Measured during 20-40 minutes of exercise
measure: Time to fatigue
timeFrame: Measured during 20-40 minutes of exercise
Secondary outcomes:
measure: Ratings of perceived exertion
timeFrame: Measured during 20-40 minutes of exercise
measure: Heart rate
timeFrame: Measured during 20-40 minutes of exercise
Other outcomes:
Locations:
Study officials:
References: