- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03709095
Sprint Interval Training During Rehabilitation After Spinal Cord Injury (SprintSCI)
October 15, 2018 updated by: McMaster University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4L8
- McMaster University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unable to perform arm-ergometry training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Moderate Intensity Continuous Training
Training 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.
|
Participants utilized the arm ergometer for improving aerobic exercise capacity
|
|
Experimental: Sprint Interval Training
The 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.
|
Participants utilized the arm ergometer for improving aerobic exercise capacity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in peak power output
Time Frame: Change in peak power output from baseline to 5 weeks
|
maximum amount of power produced during a graded exercise test on the arm-ergometer
|
Change in peak power output from baseline to 5 weeks
|
|
Change in sub-maximal arm-ergometry
Time Frame: Change in sub-maximal arm-ergometry from baseline to 5 weeks
|
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.
|
Change in sub-maximal arm-ergometry from baseline to 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular Responses
Time Frame: Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
|
Monitored heart rate throughout each training session
|
Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
|
|
Perceptual Responses
Time Frame: Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
|
Monitored ratings of perceived exertion throughout each training session
|
Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
|
|
Change in self-efficacy for exercise
Time Frame: Change in self-efficacy from baseline to 5 weeks
|
Using a self-reported questionnaire, participants rated how confident they are with regards to performing and carrying out regular physical activities and exercises.
|
Change in self-efficacy from baseline to 5 weeks
|
|
Exercise Satisfaction
Time Frame: Measured only at the end of the intervention (5 weeks)
|
Participants completed the Physical Activity Enjoyment Scale (PACES) in order to asses the level of enjoyment with the training intervention they received.
|
Measured only at the end of the intervention (5 weeks)
|
|
Pain perceptions
Time Frame: Measured only at the end of the intervention (5 weeks)
|
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 only at the end of the intervention (5 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Audrey L Hicks, PhD, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2017
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
October 11, 2018
First Submitted That Met QC Criteria
October 15, 2018
First Posted (Actual)
October 17, 2018
Study Record Updates
Last Update Posted (Actual)
October 17, 2018
Last Update Submitted That Met QC Criteria
October 15, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SprintSCI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Exercise
-
Centre Hospitalier de CorbieRecruitingExercise Training | Cardiac Rehabilitation | Exercise Intolerance | Exercise Intervention | Exercise Adaptations | HFrEF - Heart Failure With Reduced Ejection FractionFrance
-
Hamza KucukCompletedExercise Training | Exercise PhysiologyTurkey (Türkiye)
-
Faculdade de Motricidade HumanaCompletedGreen Exercise | Indoor ExercisePortugal
-
Lindenwood UniversityIncrenovo, LLCRecruitingCognitive Function | Blood Flow | Nitric Oxide | Endurance Exercise | Exercise Performance | Exercise RecoveryUnited States
-
Egas Moniz - Cooperativa de Ensino Superior, CRLCompletedAgeing | Aerobic Exercise | Resistance Exercise | Combined ExercisePortugal
-
Universidad Rey Juan CarlosCompletedEndurance Exercise | Running Performance | Exercise PhysiologySpain
-
Istanbul Sabahattin Zaim UniversityT.C. Dumlupınar ÜniversitesiCompletedExercise Ergogenics | Recovery Methods | Carnitine Ingestion | Exercise Fatigue | Exercise and RecoveryTurkey (Türkiye)
-
Hasan Kalyoncu UniversityNot yet recruiting
-
University of HawaiiKlein Buendel, Inc.CompletedMomZing Exercise Videos Online | Standard Exercise DVDUnited States
-
Istanbul Medipol University HospitalCompletedPulmonary Rehabilitation | Exercise Capacity | Exercise TestTurkey
Clinical Trials on moderate intensity continuous training
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
Riphah International UniversityCompleted
-
National Taiwan University HospitalUnknownPhysical Activity | Exercise | Metabolic Syndrome XTaiwan
-
Riphah International UniversityCompleted
-
University of British ColumbiaRecruitingExercise TrainingCanada
-
VA Office of Research and DevelopmentRecruitingRelationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia (RAN)FibromyalgiaUnited States
-
Riphah International UniversityActive, not recruitingPrehypertensionPakistan
-
Han Yaling, MDRecruitingCardiac Rehabilitation | Valve Disease, AorticChina
-
Indonesia UniversityNot yet recruiting