Spinal Cord InjuriesNCT04465825
Developing Strategies to Optimize the Exercise Response After Tetraplegia.
A study testing HITT: intermittent high intensity exercise in people with Spinal Cord Injuries and Spinal Cord Injury Cervical, run by University of Manitoba.
Trial summary
To identify means to improve exercise performance in participants with tetraplegia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Injury Cervical, Paraplegia, Spinal
- What is being tested?
- HITT: intermittent high intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Known thyroid dysfunction
- Current cancer
- Current uncontrolled high blood pressure ( > 140/90 mmHg)
- Uncontrolled epilepsy
- Current deep vein thrombosis
- Ventilator-dependent
- Cognitive impairment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Developing Strategies to Optimize the Exercise Response in Persons Living With Tetraplegia.
To identify means to improve exercise performance in participants with tetraplegia.
Read the 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.
- Being tested
- HITT: intermittent high intensity exercise
- Keywords
- exercise
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITT: intermittent high intensity exerciseBehavioural
Intermittent bouts of 30-60 seconds of exercise at 90% of peak intensity (HITT).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HITT: intermittent high intensity exercise |
| Acute exercise bout with no HITT | No intervention | Exercise will occur at 50% peak without introducing HITT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure in ml of oxygen consumed per minute per kg of body weight
Estimation of energy expenditure for bout of exercise
Measured: Measured during 20-40 minutes of exercise
Time to fatigue
Total duration of exercise
Measured: Measured during 20-40 minutes of exercise
Secondary outcomes (2)
Ratings of perceived exertion
Ratings of perceived exertion during exercise
Measured: Measured during 20-40 minutes of exercise
Heart rate
We will examine differences in average, peak HR and HR variability
Measured: Measured during 20-40 minutes of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study startJun 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Part 2 is a randomized crossover design.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465825
- Sponsor's protocol ID
- HS22987
- Status last verified
- Jun 2020
- First submitted
- 7 Jul 2020
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once published we will strive to make anonymized study data available.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Strategies to Optimize the Exercise Response in Persons Living With Tetraplegia.
- ClinicalTrials.gov ID
- NCT04465825
- Acronym / sponsor ID
- HS22987
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part 2 is a randomized crossover design.
| Arm | Type | Receives |
|---|---|---|
| Interspersing HITT in exercise | Active comparator | Behavioral: HITT: intermittent high intensity exerciseWe will test whether introducing HITT into an acute exercise bout will increase overall energy expenditure or time to fatigue. |
| Acute exercise bout with no HITT | No intervention | –Exercise will occur at 50% peak without introducing HITT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HITT: intermittent high intensity exerciseIntermittent bouts of 30-60 seconds of exercise at 90% of peak intensity (HITT). | Behavioural | Interspersing HITT in exercise |
Primary outcome
Energy expenditure in ml of oxygen consumed per minute per kg of body weight
Time frame: Measured during 20-40 minutes of exercise
Estimation of energy expenditure for bout of exercise
Time to fatigue
Time frame: Measured during 20-40 minutes of exercise
Total duration of exercise
2 secondary outcomes
Ratings of perceived exertion
Time frame: Measured during 20-40 minutes of exercise
Heart rate
Time frame: Measured during 20-40 minutes of exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Individual participant dataSharing planned: Yes. Once published we will strive to make anonymized study data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing HITT: intermittent high intensity exercise in people with Spinal Cord Injuries and Spinal Cord Injury Cervical, run by University of Manitoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristine C Cowley, Ph.D. (2047893305, kristine.cowley@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure in ml of oxygen consumed per minute per kg of body weight (time frame: Measured during 20-40 minutes of exercise). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.