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Spinal Cord InjuriesSprintSCINCT03709095

Sprint Interval Training During Rehabilitation After Spinal Cord Injury

A study testing Sprint interval training and moderate intensity continuous training in people with Spinal Cord Injuries and Rehabilitation, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Immediately following a spinal cord injury (SCI), patients are admitted to inpatient rehabilitation where they undergo physical reconditioning in preparation for a return to home setting. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injuries, Rehabilitation, Exercise
What is being tested?
Sprint interval training and moderate intensity continuous training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
1 Jun 2017to 1 Jun 2018
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with sub-acute spinal cord injury (time since injury: 14 - 182 days)
  • Undergoing inpatient rehabilitation
  • Aged 18-65 years
  • Injury level at the second cervical vertebrae (C2) or below

Who cannot join

  • Unable to perform arm-ergometry training

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University

    Hamilton, Ontario, L8S 4L8

Other trials in Canada

About this study

Immediately following a spinal cord injury (SCI), patients are admitted to inpatient rehabilitation where they undergo physical reconditioning in preparation for a return to home setting. The current standard of practice for aerobic training is performing arm-ergometry for 25 mins at a frequency of three times per week. Given the move towards shortened length of stay during inpatient rehabilitation, performing MICT can consume a considerable amount of therapy time. Sprint interval training (SIT) has been shown to elicit similar improvements in physical capacity, despite a reduced time commitment to MICT. However, there are no controlled trials comparing the effects of SIT to MICT in individuals with SCI undergoing inpatient rehabilitation. The primary aim of this study was to investigate the efficacy of a five-week, thrice weekly 10 min SIT program and compare outcome measures to a traditional 25 minute MICT program on the arm-ergometer in individuals with SCI undergoing inpatient clinical rehabilitation. It was hypothesized that five weeks of SIT and MICT would induce similar changes in maximal and sub-maximal exercise performance, self-efficacy for exercise, and exercise enjoyment, despite large differences in training volume and time commitment. It was also hypothesized that SIT would be well tolerated and elicit higher levels of cardiovascular strain than MICT.

Being tested
Sprint interval training, moderate intensity continuous training
Keywords
Inpatient Rehabilitation, Sprint interval training, Exercise, Spinal Cord Injury
Medical subject headings
Spinal Cord Injuries, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sprint interval trainingOther

    Participants utilized the arm ergometer for improving aerobic exercise capacity

  • moderate intensity continuous trainingOther

    Participants utilized the arm ergometer for improving aerobic exercise capacity

Study groups in NCT03709095
Study groupRoleWhat they receive
Moderate Intensity Continuous TrainingActive comparatorTraining was performed three times a week for five weeks. Each session began with a 2 minute warm up, and concluded with a 3 minute cool down. Following the warm-up, participants performed 20 minutes of arm cycling at a self-selected cadence at 45-65% of their peak power output. Total training duration was 25 mins.
Receives: Other: moderate intensity continuous training
Sprint Interval TrainingExperimentalThe SIT protocol was adopted from Gillen and colleagues (See Ref), and consisted of 3 x 20 second "all-out" efforts at ≥ 100% of an individuals peak power output. Each sprint was interspersed by 120 seconds of active recovery at 10% of an individuals peak power output. Total training duration was 10 mins.
Receives: Other: Sprint interval training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in peak power output

    maximum amount of power produced during a graded exercise test on the arm-ergometer

    Measured: Change in peak power output from baseline to 5 weeks

  2. Change in sub-maximal arm-ergometry

    Participants performed three 5-minute steady state workloads on the arm-ergometer at power outputs corresponding to RPE's of 8, 10 and 12. Participants were given a minimum of 2 minutes, and a maximum of 5 minutes of rest in between each workload.

    Measured: Change in sub-maximal arm-ergometry from baseline to 5 weeks

Secondary outcomes (5)

  1. Cardiovascular Responses

    Monitored heart rate throughout each training session

    Measured: Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)

  2. Perceptual Responses

    Monitored ratings of perceived exertion throughout each training session

    Measured: Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)

  3. Change in self-efficacy for exercise

    Using a self-reported questionnaire, participants rated how confident they are with regards to performing and carrying out regular physical activities and exercises.

    Measured: Change in self-efficacy from baseline to 5 weeks

  4. Exercise Satisfaction

    Participants completed the Physical Activity Enjoyment Scale (PACES) in order to asses the level of enjoyment with the training intervention they received.

    Measured: Measured only at the end of the intervention (5 weeks)

  5. Pain perceptions

    Through a questionnaire, participants rated how much shoulder pain, bodily pain, and physical discomfort they typically experience throughout the day and how much pain they experienced with the intervention they were allocated to.

    Measured: Measured only at the end of the intervention (5 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2018
  2. Study start1 Jun 2017
  3. Primary completion1 Jun 2018
  4. Study completion1 Jun 2018

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomized to one of two groups: (A) sprint interval training (SIT) or (B) moderate intensity continuous training (MICT).
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03709095
Sponsor's protocol ID
SprintSCI
Acronym
SprintSCI
Status last verified
Oct 2018
First submitted
11 Oct 2018
Last updated
17 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gillen JB, Martin BJ, MacInnis MJ, Skelly LE, Tarnopolsky MA, Gibala MJ. Twelve Weeks of Sprint Interval Training Improves Indices of Cardiometabolic Health Similar to Traditional Endurance Training despite a Five-Fold Lower Exercise Volume and Time Commitment. PLoS One. 2016 Apr 26;11(4):e0154075. doi: 10.1371/journal.pone.0154075. eCollection 2016.

    PubMed 27115137

  • Hicks AL, Martin KA, Ditor DS, Latimer AE, Craven C, Bugaresti J, McCartney N. Long-term exercise training in persons with spinal cord injury: effects on strength, arm ergometry performance and psychological well-being. Spinal Cord. 2003 Jan;41(1):34-43. doi: 10.1038/sj.sc.3101389.

    PubMed 12494319

  • Nightingale TE, Metcalfe RS, Vollaard NB, Bilzon JL. Exercise Guidelines to Promote Cardiometabolic Health in Spinal Cord Injured Humans: Time to Raise the Intensity? Arch Phys Med Rehabil. 2017 Aug;98(8):1693-1704. doi: 10.1016/j.apmr.2016.12.008. Epub 2017 Jan 13.

    PubMed 28089898

  • Astorino TA, Thum JS. Within-session responses to high-intensity interval training in spinal cord injury. Disabil Rehabil. 2018 Feb;40(4):444-449. doi: 10.1080/09638288.2016.1260648. Epub 2016 Dec 8.

    PubMed 27930890

Questions about this trial

What is this clinical trial studying?

A study testing Sprint interval training and moderate intensity continuous training in people with Spinal Cord Injuries and Rehabilitation, run by McMaster University at 1 site in Canada.

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 4 inclusion and 1 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: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in peak power output (time frame: Change in peak power output from baseline to 5 weeks). 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?

On the ClinicalTrials.gov record for NCT03709095, which also lists 4 linked publications.

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 17 Oct 2018.

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