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

NCT05989906 | Enrolling By Invitation

• 1 other identifier: STUDY00017002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the feasibility and efficacy of 3 treatments to increase physical activity during and after inpatient rehabilitation (IPR) for new spinal cord injuries:

1. 1.Program of sprint interval training (SIT) on an arm crank ergometer during IPR
2. 2.SIT + Provision of an arm ergometer (ERGO) for home use
3. 3.SIT + ERGO for home use + Motivational interviewing to increase adherence to exercise during and after IPR.

Conditions

Spinal Cord Injuries

Keywords

Exercise; Mental Health; Feasibility; Inpatient Rehabilitation Unit; Sprint Interval Training

Outcome Measures

Primary Outcomes (4)

• Total physical activity (vector magnitude) per week

  To compare the effect sizes (Cohen's d) of each of the three treatment conditions: (1) SIT alone, (2) SIT+ERGO, and (3) SIT+ERGO+MI relative to usual care on the primary outcome, total physical activity (vector magnitude) per week at 6 months post discharge measured by an Actigraph GT3X worn on the non-dominant wrist for 7 days.

  7 day assessment (at 6 month timepoint)

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

  Investigators will assess the total number and percentage of participants that complete at least six SIT sessions, the minimum number of SIT sessions associated with a significant increase in physical capacity among SCI participants.

  Treatment Completion (week 3)

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

  Among patients who received a home ergometer, the investigators will assess how many sessions of SIT the participants completed between treatment completion (in hospital) and the 6-month timepoint.

  6 Month Follow Up (week 24)

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

  Investigators will assess the total number and percentage of participants that completed at least 75% of the Sprint Interval Training sessions among participants that received Motivational Interviewing.

  6 Month Follow Up (week 24)

Secondary Outcomes (13)

• Adverse Events (Safety)

  At the end of each Sprint Interval Training (SIT) session during weeks 0-4 of the study and at the end of the 6-minute arms tests (weeks 0-4)

• Acceptability

  Treatment Completion (week 4), 6 Month Follow Up (week 24)

• Peak power on the 6-Minute Arm Test (6-MAT)

  Self-reported physical exertion at the end of 6 minutes of physical exercise on the arm ergometer at Baseline (week 0) and at Treatment Completion (week 4)

• Leisure Time Physical Activity (LTPA)

  Treatment Completion (week 4), 6 Month Follow Up (week 24)

• Patient Health Questionnaire (PHQ-9)

  Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)

Study Arms (4)

Usual Care

ACTIVE COMPARATOR

Participant will take part in the usual care during inpatient rehabilitation

Behavioral: Usual Care

Spring Interval Training (SIT)

EXPERIMENTAL

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

Behavioral: Sprint Interval Training (SIT)

SIT + ERGO

EXPERIMENTAL

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.

Behavioral: Sprint Interval Training (SIT); Behavioral: Home Ergometer (ERGO)

SIT + ERGO + MI

EXPERIMENTAL

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

Behavioral: Sprint Interval Training (SIT); Behavioral: Home Ergometer (ERGO); Behavioral: Motivational Interviewing (MI)

Interventions

Sprint Interval Training (SIT) BEHAVIORAL

Participants will undergo 1:1 therapist supervised SIT for 10 minutes per day, three times per week during IPR using a Monark 881 arm crank ergometer.

SIT + ERGO; SIT + ERGO + MI; Spring Interval Training (SIT)

Usual Care BEHAVIORAL

Participants will have the opportunity to participate in optional group endurance exercise classes two to three times a week.

Usual Care

Home Ergometer (ERGO) BEHAVIORAL

Participants complete the SIT intervention during IPR and be provided with a consumer-grade ergometer. Study staff will train the participants in the set-up and use of the home ergometer prior to discharge and arrange for take home or delivery.

SIT + ERGO; SIT + ERGO + MI

Motivational Interviewing (MI) BEHAVIORAL

Participants complete the SIT intervention during IPR and be provided with a consumer-grade ergometer. Study staff will train the participants in the set-up and use of the home ergometer prior to discharge and arrange for take home or delivery. These participants will also receive weekly Motivational Interviewing (MI) counseling sessions during IPR plus six post-discharge MI sessions delivered via telehealth to be held over six months.

SIT + ERGO + MI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with SCI
• SCI below C2
• AIS A-C
• aged 18-65
• undergoing acute IPR for SCI at Harborview Medical Center
• Able to use an arm ergometer

You may not qualify if:

• poorly controlled type II diabetes
• unstable cardiovascular disease
• shoulder injury
• any other medical condition that would preclude safe participation in study procedures.

Sponsors & Collaborators

• University of Washington: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity; Psychological Well-Being

Interventions

High-Intensity Interval Training; Motivational Interviewing

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Deborah A Crane, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research study assistant collecting self-report outcomes and Principal Investigators will be masked to participant's study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine

Model Details: Participants will be randomly assigned to one of four treatment conditions: * Usual care * Sprint Interval Training * SIT + Home Ergometer * SIT + Home Ergometer + Motivational Interviewing

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 14, 2023
• Study Start: August 23, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)