Clinical trial NCT05989906: Feasibility of a Sprint Interval Training Program During Inpatient Spinal Cord Injury Rehabilitation
Official title: Feasibility of a Sprint Interval Training Program During Inpatient Spinal Cord Injury Rehabilitation: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Exercise
Mental Health
Feasibility
Inpatient Rehabilitation Unit
Sprint Interval Training
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2023-08-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of four treatment conditions:

* Usual care
* Sprint Interval Training
* SIT + Home Ergometer
* SIT + Home Ergometer + Motivational Interviewing
Primary purpose: TREATMENT

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

The primary outcome is minutes per week of moderate to vigorous physical activity at 6 months after IPR discharge. Secondary outcomes include peak power on the 6-Minute Arm Test at IPR discharge and self-reported physical activity, depression, fatigue, pain, community participation, and quality of life at 6 months after IPR discharge. The investigators will obtain data on feasibility, acceptability, and perceived benefits of the treatments from stakeholders. The results of this pilot study will inform the design of a larger randomized trial.

Detailed description: Description of the Sprint Interval Training Condition

The SIT treatment procedures will parallel the procedures used in the successful comparative effectiveness trial of SIT versus Moderate Intensity Continuous Training (MICT) during IPR in Canada.

SIT participants will be trained to use an ergometer on a Monark 881 mechanically braked arm ergometer purchased for the study. The Monark will be mounted on a rolling table designed for this purpose, so training can take place in patient rooms or in one of several small therapy rooms adjacent to the inpatient rehabilitation unit. Sessions will begin with the physical or occupational therapist showing the participant the RPE scale (Borg 6-20) posted behind the ergometer and instructing the participant in how to report perceived exertion during each session. The therapist will position the ergometer axle at shoulder height and close enough to the participant to maintain slight elbow flexion. They will attach the heart rate monitor, validate initial recordings, assess resting RPE, and record resting HR and blood pressure. They will have the participant begin a two-minute warm-up at a self-selected speed and zero resistance followed by three 20-second intervals of all-out effort interspersed by 120 seconds of active recovery at zero resistance. During each interval, participants will be instructed to achieve a cadence of approximately 100 revolutions per minute for persons with paraplegia and approximately 85 revolutions per minute for people with tetraplegia. The therapist will adjust ergometer resistance as needed to maintain RPE ratings between 15-17. Rating of perceived exertion is a valid method to prescribe interval exercise intensity and preferable to HR. Heart rate will be recorded continuously and averaged over the entire training session excluding the warm-up and recovery periods. RPE will be measured at the end of each sprint interval training session. To accommodate training adaptation over time, the resistance on the ergometer will be increased to maintain a peripheral RPE of 16. SIT training was well-tolerated and safe in the prior IPR trial as well as in several post-acute SCI studies. Hypotension is a potential adverse event in this setting, especially immediately post-exercise. Thus, sessions will include blood pressure monitoring and surveillance for symptoms of hypotension during and after the exercise session. Adverse events will be reported to the research team for review by the DSMB. SIT training will take place approximately 3 times per week.

Description of the Home Arm Ergometer Condition

Participants randomized to receive ERGO will also take part in SIT approximately 3 times per week. Participants will undergo at least one SIT session on the consumer grade ergometer under supervision of the physical or occupational therapist. The therapist/team will demonstrate all the features of the device set up, use, and resistance adjustment to the patient and caregiver (if available). The therapist/team will problem-solve barriers to home use prior to discharge and contact the patient soon after discharge to help resolve additional problems that may have emerged. The patient will be sent home with an exercise log-sheet like the one used during IPR to guide continued training. Prior to discharge the study team will arrange to have the ergometer given to or shipped to the participant's discharge residence.

The investigators plan to give participants randomized to ERGO a consumer grade tabletop ergometer. Study staff will also provide ace bandages or specialized exercise gloves for patients with tetraplegia who cannot grip the ergometer handles.

Description of the Motivational Interviewing Condition

The motivational interviewing (MI) condition participants will take part in SIT approximately 3 times per week and be provided an ERGO for home use. In addition, participants will receive MI. The sessions will use a MI counseling style consisting of strategic use of open questions, reflections, affirmations, summaries, and information sharing. MI is a widely used, evidence-based counseling approach with evidence of efficacy across many different health behaviors including exercise promotion. The sessions will also include evidence-based content and behavior change principles such as goal setting, activity monitoring, feedback, and identification of barriers and facilitators. This content has been adapted for people with SCI from an unusually successful and highly replicated lifestyle intervention (the Diabetes Prevention Program (DPP)). The investigators will include 10 DPP modules on values and goals, self-monitoring, exercise safety, problem-solving I, relapse prevention, activity cues, problem-solving II, professional help, dealing with negative thoughts, and staying motivated. Participants will receive approximately four weekly 30-minute in-person counseling sessions during IPR and six monthly telehealth sessions during the post-discharge period provided by Dr. Bombardier, an expert in MI and exercise promotion.

Description of the Usual Care Control Condition

Study design includes a control group because our aims include preliminary efficacy as well as feasibility. The investigators chose Usual Care as the control group over other control group options, such as traditional moderate intensity aerobic conditioning in order to know whether the treatment components are potentially more effective than current standard of care. Also, traditional aerobic conditioning (30-45 minute sessions 3 times per week) is not a current component of IPR in the U.S. and is likely not feasible. All patients, including those assigned to usual care, may participate in optional group endurance exercise classes at the end of the day 2-3 times per week. Endurance group classes include moderate intensity continuous aerobic training using any equipment appropriate to the patient's level and severity of injury, as determined by the treating physical therapist.

Data Collection and Measurement Techniques There will be three assessment points: baseline, within the week prior to end of treatment/discharge from IPR, and at 6 months post discharge from IPR. All outcome assessments will be conducted by a trained and supervised research assistant who will be kept unaware of the participants treatment condition. Patient reported outcomes will be assessed via in-person structured interviews for baseline and discharge and via Zoom or telephone for 6-month assessments. A 6-MAT (6 minute arm test) will be done on an arm ergometer around the time of the baseline survey and repeated within one week prior to discharge from IPR. Participants will be asked to wear an Actigraph activity monitor for 1 week approximately 6 months after discharge.

Eligibility criteria: Inclusion Criteria:

1. Adults with SCI
2. SCI below C2
3. AIS A-C
4. aged 18-65
5. undergoing acute IPR for SCI at Harborview Medical Center
6. Able to use an arm ergometer

Exclusion Criteria:

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

Primary outcomes:
measure: Total physical activity (vector magnitude) per week
timeFrame: 7 day assessment (at 6 month timepoint)
measure: Percentage of participants that complete at least six Sprint Interval Training (SIT) sessions
timeFrame: Treatment Completion (week 3)
measure: Total number of Ergometer (ERGO) sessions that participants complete between treatment completion and 6 month follow up
timeFrame: 6 Month Follow Up (week 24)
measure: Percentage of participants that adhere to Sprint Interval Training sessions and received Motivational Interviewing (MI) sessions
timeFrame: 6 Month Follow Up (week 24)
Secondary outcomes:
measure: Adverse Events (Safety)
timeFrame: 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)
measure: Acceptability
timeFrame: Treatment Completion (week 4), 6 Month Follow Up (week 24)
measure: Peak power on the 6-Minute Arm Test (6-MAT)
timeFrame: 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)
measure: Leisure Time Physical Activity (LTPA)
timeFrame: Treatment Completion (week 4), 6 Month Follow Up (week 24)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)
measure: Patient Reported Outcome Measures Information System (PROMIS) Fatigue Short Form
timeFrame: Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)
measure: Numerical Rating Scale (NRS) of Worst/Average Pain
timeFrame: Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)
measure: Wheelchair Users Shoulder Pain Inventory (WUSPI)
timeFrame: Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)
measure: Physical Activity Enjoyment Scale (PACES)
timeFrame: Within 5 minutes after each Sprint Interval Training session during first 3 weeks of study (weeks 0-3)
measure: Spinal Cord Injury Exercise Self-Efficacy
timeFrame: Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)
measure: SCI Quality of Life
timeFrame: Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)
measure: Oral Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline (week 0), Treatment Completion (week 4)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Deborah A Crane, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: