Developing Strategies to Optimize the Exercise Response After Tetraplegia.

Sponsor
University of Manitoba (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04465825
Collaborator
(none)
16
2
18

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HITT: intermittent high intensity exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Part 2 is a randomized crossover design.Part 2 is a randomized crossover design.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Developing Strategies to Optimize the Exercise Response in Persons Living With Tetraplegia.
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Energy expenditure in ml of oxygen consumed per minute per kg of body weight [Measured during 20-40 minutes of exercise]

    Estimation of energy expenditure for bout of exercise

  2. Time to fatigue [Measured during 20-40 minutes of exercise]

    Total duration of exercise

Secondary Outcome Measures

  1. Ratings of perceived exertion [Measured during 20-40 minutes of exercise]

    Ratings of perceived exertion during exercise

  2. Heart rate [Measured during 20-40 minutes of exercise]

    We will examine differences in average, peak HR and HR variability

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Manitoba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT04465825
Other Study ID Numbers:
  • HS22987
First Posted:
Jul 10, 2020
Last Update Posted:
May 12, 2021
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Manitoba
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2021