NCT03709095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 11, 2018

Last Update Submit

October 15, 2018

Conditions

Keywords

Inpatient RehabilitationSprint interval trainingExerciseSpinal Cord Injury

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Cardiovascular Responses

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

  • Perceptual Responses

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

  • Change in self-efficacy for exercise

    Change in self-efficacy from baseline to 5 weeks

  • Exercise Satisfaction

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

  • Pain perceptions

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

Study Arms (2)

Moderate Intensity Continuous Training

ACTIVE COMPARATOR

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.

Other: moderate intensity continuous training

Sprint Interval Training

EXPERIMENTAL

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.

Other: Sprint interval training

Interventions

Participants utilized the arm ergometer for improving aerobic exercise capacity

Sprint Interval Training

Participants utilized the arm ergometer for improving aerobic exercise capacity

Moderate Intensity Continuous Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Unable to perform arm-ergometry training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (4)

  • 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.

    PMID: 27115137BACKGROUND
  • 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.

    PMID: 12494319BACKGROUND
  • 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.

    PMID: 28089898BACKGROUND
  • 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.

    PMID: 27930890BACKGROUND

MeSH Terms

Conditions

Spinal Cord InjuriesMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Audrey L Hicks, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomized to one of two groups: (A) sprint interval training (SIT) or (B) moderate intensity continuous training (MICT).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 17, 2018

Study Start

June 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations