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Developing Strategies to Optimize the Exercise Response After Tetraplegia.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04465825
Enrollment
16
Registered
2020-07-10
Start date
2021-06-30
Completion date
2022-12-31
Last updated
2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paraplegia, Spinal, Spinal Cord Injuries, Spinal Cord Injury Cervical

Keywords

exercise

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.

Interventions

BEHAVIORALHITT: intermittent high intensity exercise

Intermittent bouts of 30-60 seconds of exercise at 90% of peak intensity (HITT).

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Part 2 is a randomized crossover design.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Energy expenditure in ml of oxygen consumed per minute per kg of body weightMeasured during 20-40 minutes of exerciseEstimation of energy expenditure for bout of exercise
Time to fatigueMeasured during 20-40 minutes of exerciseTotal duration of exercise

Secondary

MeasureTime frameDescription
Ratings of perceived exertionMeasured during 20-40 minutes of exerciseRatings of perceived exertion during exercise
Heart rateMeasured during 20-40 minutes of exerciseWe will examine differences in average, peak HR and HR variability

Contacts

Primary ContactKristine C Cowley, Ph.D.
kristine.cowley@umanitoba.ca2047893305

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026