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Sprint Interval Training During Rehabilitation After Spinal Cord Injury (SprintSCI)

Primary Purpose

Spinal Cord Injuries, Rehabilitation, Exercise

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sprint interval training
moderate intensity continuous training
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring Inpatient Rehabilitation, Sprint interval training, Exercise, Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Moderate Intensity Continuous Training

Sprint Interval Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in peak power output
maximum amount of power produced during a graded exercise test on the arm-ergometer
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.

Secondary Outcome Measures

Cardiovascular Responses
Monitored heart rate throughout each training session
Perceptual Responses
Monitored ratings of perceived exertion throughout each training session
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.
Exercise Satisfaction
Participants completed the Physical Activity Enjoyment Scale (PACES) in order to asses the level of enjoyment with the training intervention they received.
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.

Full Information

First Posted
October 11, 2018
Last Updated
October 15, 2018
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03709095
Brief Title
Sprint Interval Training During Rehabilitation After Spinal Cord Injury
Acronym
SprintSCI
Official Title
Sprint Interval Training During Rehabilitation After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Rehabilitation, Exercise
Keywords
Inpatient Rehabilitation, Sprint interval training, Exercise, Spinal Cord Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate Intensity Continuous Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sprint Interval Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sprint interval training
Intervention Description
Participants utilized the arm ergometer for improving aerobic exercise capacity
Intervention Type
Other
Intervention Name(s)
moderate intensity continuous training
Intervention Description
Participants utilized the arm ergometer for improving aerobic exercise capacity
Primary Outcome Measure Information:
Title
Change in peak power output
Description
maximum amount of power produced during a graded exercise test on the arm-ergometer
Time Frame
Change in peak power output from baseline to 5 weeks
Title
Change in sub-maximal arm-ergometry
Description
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.
Time Frame
Change in sub-maximal arm-ergometry from baseline to 5 weeks
Secondary Outcome Measure Information:
Title
Cardiovascular Responses
Description
Monitored heart rate throughout each training session
Time Frame
Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
Title
Perceptual Responses
Description
Monitored ratings of perceived exertion throughout each training session
Time Frame
Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
Title
Change in self-efficacy for exercise
Description
Using a self-reported questionnaire, participants rated how confident they are with regards to performing and carrying out regular physical activities and exercises.
Time Frame
Change in self-efficacy from baseline to 5 weeks
Title
Exercise Satisfaction
Description
Participants completed the Physical Activity Enjoyment Scale (PACES) in order to asses the level of enjoyment with the training intervention they received.
Time Frame
Measured only at the end of the intervention (5 weeks)
Title
Pain perceptions
Description
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.
Time Frame
Measured only at the end of the intervention (5 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey L Hicks, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27115137
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.
Results Reference
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PubMed Identifier
12494319
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. doi: 10.1038/sj.sc.3101389.
Results Reference
background
PubMed Identifier
28089898
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.
Results Reference
background
PubMed Identifier
27930890
Citation
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.
Results Reference
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Sprint Interval Training During Rehabilitation After Spinal Cord Injury

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