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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03709095
Other study ID # SprintSCI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date June 1, 2018

Study information

Verified date October 2018
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Sprint interval training
Participants utilized the arm ergometer for improving aerobic exercise capacity
moderate intensity continuous training
Participants utilized the arm ergometer for improving aerobic exercise capacity

Locations

Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (2)

Lead Sponsor Collaborator
McMaster University Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in peak power output maximum amount of power produced during a graded exercise test on the arm-ergometer Change in peak power output from baseline to 5 weeks
Primary 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. Change in sub-maximal arm-ergometry from baseline to 5 weeks
Secondary Cardiovascular Responses Monitored heart rate throughout each training session Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
Secondary Perceptual Responses Monitored ratings of perceived exertion throughout each training session Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
Secondary 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. Change in self-efficacy from baseline to 5 weeks
Secondary 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 only at the end of the intervention (5 weeks)
Secondary 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 only at the end of the intervention (5 weeks)
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