Developing Strategies to Optimize the Exercise Response After Tetraplegia.

NCT04465825 | Unknown

• 1 other identifier: HS22987
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Keywords

exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Ratings of perceived exertion

  Measured during 20-40 minutes of exercise

• Heart rate

  Measured during 20-40 minutes of exercise

Study Arms (2)

Interspersing HITT in exercise

ACTIVE COMPARATOR

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

Acute exercise bout with no HITT

NO INTERVENTION

Exercise will occur at 50% peak without introducing HITT.

Interventions

HITT: intermittent high intensity exercise BEHAVIORAL

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

Interspersing HITT in exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Kristine C Cowley, Ph.D.

CONTACT

2047893305; kristine.cowley@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Part 2 is a randomized crossover design.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: June 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2022
• Last Updated: May 12, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available once published for one year.