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Behavioural Intervention

Sprint Interval Training for Spinal Cord Injury (SIT Trial)

N/A

Waitlist Available

Led By Deborah A Crane, MD, MPH

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment completion (week 4), 6 month follow up (week 24)

Awards & highlights

SIT Trial Summary

This trial will assess 3 treatments to increase physical activity in people with new spinal cord injuries, examining outcomes such as power, self-reported activity, depression, fatigue, pain & quality of life.

Who is the study for?

Adults aged 18-65 with a new spinal cord injury (SCI) below the C2 vertebra, classified as AIS A-C, who are currently in acute inpatient rehabilitation at Harborview Medical Center and can use an arm ergometer. Excluded are those with shoulder injuries, other conditions preventing safe participation, uncontrolled diabetes type II, or unstable heart disease.Check my eligibility

What is being tested?

The study is testing three approaches to boost physical activity during/after inpatient rehab for SCI: Sprint Interval Training (SIT) on an arm crank ergometer; SIT plus a home-use ergometer; and SIT with the ergometer plus motivational interviews to encourage exercise adherence.See study design

What are the potential side effects?

While specific side effects aren't detailed for this trial, general risks may include muscle soreness or strain from using the arm crank ergometer and potential psychological discomfort from motivational interviewing.

SIT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment completion (week 4), 6 month follow up (week 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment completion (week 4), 6 month follow up (week 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment completion (week 4), 6 month follow up (week 24) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants that adhere to Sprint Interval Training sessions and received Motivational Interviewing (MI) sessions

Percentage of participants that complete at least six Sprint Interval Training (SIT) sessions

Total number of Ergometer (ERGO) sessions that participants complete between treatment completion and 6 month follow up

+1 more

Secondary outcome measures

Acceptability

Adverse Events (Safety)

Generalized Anxiety Disorder (GAD-7)

+10 more

SIT Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Spring Interval Training (SIT)Experimental Treatment1 Intervention

Participant will take part in SIT approximately three times per week during inpatient rehabilitation.

Group II: SIT + ERGO + MIExperimental Treatment3 Interventions

Participant will take part in SIT approximately three times per week during inpatient rehabilitation. In addition, participant will be provided with an consumer grade ergometer for home use. The participant will receive Motivational Interviewing sessions with a rehab psychologist one time per week (approximately 4 sessions) during inpatient rehabilitation and one time per month for six months after discharge from the hospital

Group III: SIT + ERGOExperimental Treatment2 Interventions

Participant will take part in SIT approximately three times per week during inpatient rehabilitation. In addition, participant will be provided with an consumer grade ergometer for home use.

Group IV: Usual CareActive Control1 Intervention

Participant will take part in the usual care during inpatient rehabilitation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Motivational Interviewing (MI)

2010

Completed Phase 3

~2830

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,738 Previous Clinical Trials

1,844,319 Total Patients Enrolled

The Craig H. Neilsen FoundationOTHER

54 Previous Clinical Trials

2,863 Total Patients Enrolled

Deborah A Crane, MD, MPHPrincipal InvestigatorUniversity of Washington

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for inclusion in this study restricted to those below 40 years old?

"This medical trial is open to individuals 18 years of age or older and under the age of 65."

Answered by AI

Are any participants in this research project being accepted at the moment?

"This investigation, which was published on August 23rd 2023, is not currently accepting new patients. Per the details posted on clinicaltrials.gov, this trial has been recently updated and thus is no longer in recruitment mode; yet there are 932 other medical studies that require enrolment at present time."

Answered by AI

Is it possible to participate in this research trial?

"32 subjects who have suffered a spinal cord injury and meet the criteria of 18-65 years old are invited to participate in this trial. The prerequisites for enrollment include: experiencing an acute IPR at Harborview Medical Center, SCI below C2 on ASIA Impairment Scale (AIS), capacity to use arm ergometer, etc."

Answered by AI

What are the foundational goals of this experiment?

"The primary aim of this 7 day trial is to assess the percentage of participants that adhere to Sprint Interval Training and receive Motivational Interviewing (MI). Secondary endpoints include Patient Reported Outcome Measures Information System (PROMIS) Fatigue Short Form which evaluates self-reported fatigue, Numerical Rating Scale (NRS) for Worst/Average Pain measuring recent pain levels from 0-10, and Physical Activity Enjoyment Scale (PACES), a survey ranging from '0' ('I hate it') - '7' ('I enjoy it')."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of a Sprint Interval Training Program During Inpatient Spinal Cord Injury Rehabilitation

Deborah Crane 2023. "Feasibility of a Sprint Interval Training Program During Inpatient Spinal Cord Injury Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05989906.