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

Sponsor

University of Washington (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05989906

Collaborator

The Craig H. Neilsen Foundation (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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:

Program of sprint interval training on an arm crank ergometer during IPR
Provision of an arm ergometer (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 at6 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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Behavioral: Sprint Interval Training (SIT) Behavioral: Usual Care Behavioral: SIT + ERGO Behavioral: SIT + ERGO + MI	N/A

Detailed Description

Physical inactivity is a major problem facing people with SCI. In chronic SCI, about 50% of people engage in no leisure time physical activity. That is, they do not wheel or walk for pleasure, do not play a sport, and do not exercise at home or go to a gym. Approximately 1 in 4 healthy young persons with SCI lack sufficient physical fitness to perform many essential activities of daily living.

Becoming physically inactive harms physical and mental health and reduces quality of life after SCI. Physical inactivity leads to a downward spiral of loss of muscle mass, decreased resting energy expenditure, decreased total energy expenditure, obesity and further loss of muscle mass in people with disabilities including SCI. Physical inactivity is associated with an increased risk of cardiovascular disease, obesity, dyslipidemia, diabetes, and hypertension in SCI. Low physical activity (PA) is also associated with depression, chronic pain and fatigue after SCI. Many studies demonstrate an association between physical inactivity and poorer quality of life.

Current evidence-based exercise guidelines recommend that, "for cardiorespiratory fitness and muscle strength benefits, adults with a SCI should engage in at least 20 min of moderate to vigorous intensity aerobic exercise 2 times per week AND 3 sets of strength exercises for each major functioning muscle group, at a moderate to vigorous intensity, 2 times per week." A large body of research demonstrates that following these guidelines increases cardiovascular fitness, power output, and muscular strength in chronic SCI. Exercise training reduces low-density lipoprotein (bad) cholesterol, increases high-density lipoprotein (good) cholesterol in chronic SCI and improves insulin sensitivity. Most importantly for this study, increased exercise or PA is associated with improved depression, diminished pain, and better quality of life in people with chronic SCI.

Despite these promising results, research-based exercise programs for people with SCI have limited impact on this population. For example, intervention studies reach few patients. On average, only 42% of people who are eligible enroll in SCI exercise studies and the mean sample size is just 24 participants. Exercise research has focused almost exclusively on people with chronic SCI, after patterns of physical inactivity have become entrenched. Outside of research studies, people with SCI face numerous barriers to exercise. While 86% of non-exercisers desire to exercise, they face poor access to exercise facilities, limited transportation, or not having exercise equipment at home. Possibly as a result of having limited experience with exercise and falling into a sedentary lifestyle, individuals with SCI often develop perceptions about exercise that are barriers such as the belief that exercise is not enjoyable, it is too difficult, it will worsen their condition, or not knowing how to exercise.

Inpatient rehabilitation and the post discharge period is a missed opportunity to promote exercise. In the United States (U.S.), inpatient rehabilitation (IPR) currently provides little exposure to cardiovascular challenging exercise due to short duration of stay and a primary focus on achieving functional independence. During the first six months after discharge from IPR, PA generally declines and body mass increases which begins the downward spiral described above. Yet, only 10% of exercise-based studies in SCI were conducted during the first year after SCI. The investigaors think IPR is a window of opportunity to promote exercise and adoption of an active lifestyle as people are learning to live with SCI.

Researchers in the Netherlands and Canada have utilized IPR and post-IPR to promote adapted exercise habits. A prior study using interval training with handcycling during the last eight weeks of IPR showed that this form of PA is feasible and improved physical capacity. A subsequent study by the same group examined whether a handcycling program during IPR combined with motivational interviewing (MI) to increase the amount of wheeled PA each day was more effective than handcycling alone. Results reported that the group that received MI demonstrated 28 and 25 minutes more wheeled PA per day at six and 12 months post discharge relative to the handcycle only group. A recent study evaluated the feasibility and preliminary efficacy of a time efficient form of interval training during IPR. Sprint interval training (SIT) was completed in 10-minute sessions three times per week for 5 weeks. Data showed that SIT could be integrated into IPR and it produced similar effects on physical capacity that were comparable to a control group that completed traditional aerobic exercise, 75 minutes per week. In addition, a randomized controlled study in the Netherlands showed that adding MI to interval training during IPR increases PA through six months post-discharge.

While SIT appears to be a promising intervention to enhance physical capacity during IPR, and MI has potential to produce higher levels of wheeled PA after discharge, both interventions were performed in countries with much longer rehabilitation lengths of stay (LOS) than in the U.S. Whereas the median IPR LOS for people with SCI is approximately 35 days in the U.S., the mean LOS in the Netherlands and Canada is 227 days and 84 days, respectively. Therefore, it is uncertain whether SIT and MI are feasible and can be effective in the U.S. because IPR LOS is much shorter than in these countries.

There is an urgent need to examine whether it is feasible to integrate SIT and MI into IPR in the U.S. and to determine whether these intervention components can lead to increased physical activity related psychosocial benefits after discharge from the hospital. Otherwise, our rehabilitation programs will continue to discharge patients who are often unprepared to be physically active and who will adopt a sedentary lifestyle with the attendant adverse physical and psychosocial consequences.

The investigators hope that by exposing individuals with acute SCI to more efficient and effective means of exercising during IPR, they will become more physically active and reap the benefits of a more active lifestyle, that is, better mental health, physical health, and quality of life. This study also addresses critical service gaps in the U.S. model of IPR by educating participants in how to perform a SIT program and providing some with an ergometer to continue the program at home. Furthermore, the addition of motivational interviewing in one arm of the study design also seeks to increase understanding of psychological factors that affect participation in and adherence to this novel exercise program.

This line of research has the potential to initiate important changes in practice during IPR and in insurance funding. If SIT ultimately improves physical fitness, PA, and related indicators of health, then the scientific community will have evidence to advocate for inclusion of SIT as a standard aspect of IPR covered by U.S. insurance companies. Additionally, if having a home arm ergometer leads to better cardiovascular health and PA adherence, the investigators will possess scientific evidence to help advocate for insurance companies to cover these devices for patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Research study assistant collecting self-report outcomes and Principal Investigators will be masked to participant's study group.

Primary Purpose:

Treatment

Official Title:

Feasibility of a Sprint Interval Training Program During Inpatient Spinal Cord Injury Rehabilitation: A Pilot Randomized Controlled Trial

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Usual Care	Behavioral: Usual Care Participants will have the opportunity to participate in optional group endurance exercise classes two to three times a week.
Experimental: Spring Interval Training (SIT)	Behavioral: Sprint Interval Training (SIT) 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. The SIT program will replicate the training program implemented in the Canadian study conducted by McLeod et al.
Experimental: SIT + ERGO	Behavioral: SIT + ERGO Participants complete the SIT intervention during IPR, and the investigators will train the participants in the set-up and use of a consumer-grade arm ergometer (MagneTrainer) during IPR and have one delivered to their discharge destination at the time of discharge (paid for by the grant).
Experimental: SIT + ERGO + MI	Behavioral: SIT + ERGO + MI In addition to SIT and ERGO, these participants will receive weekly 30-minute Motivational Interviewing (MI) counseling sessions during IPR plus six post-discharge MI sessions delivered via telehealth to be held over six months.

Outcome Measures

Primary Outcome Measures

Total physical activity (vector magnitude) per week [7 day assessment (at 6 month timepoint)]
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.
Overall Feasibility [Treatment Completion (week 4), 6 Month Follow Up (week 24)]
To determine whether the treatment components, SIT, ERGO, and MI are feasible, safe, and acceptable during and after IPR in a U.S.-based IPR program. At the end of the 6-month follow-up assessment, the investigators will use open questions to assess barriers and facilitators to SIT, ERGO, and MI as well as strategies to improve each intervention component.
Percentage of participants that complete at least six Sprint Interval Training (SIT) sessions [Treatment Completion (week 3)]
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.
Total number of Ergometer (ERGO) sessions that participants complete between treatment completion and 6 month follow up [6 Month Follow Up (week 24)]
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.
Percentage of participants that adhere to Sprint Interval Training sessions and received Motivational Interviewing (MI) sessions [6 Month Follow Up (week 24)]
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.

Secondary Outcome Measures

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)]
The investigators will ask participants at the end of each Sprint Interval Training (SIT) session, "Have you experienced any negative effects from today's training or as a result of participating in the study?" (Yes/No). If a participant responds 'Yes', investigators will ask for more details and will report this information to the Principal Investigators.
Acceptability [Treatment Completion (week 4), 6 Month Follow Up (week 24)]
The investigators will assess overall improvement on the Benefit, Satisfaction, and Willingness to Continue survey from Treatment Completion to 6 Month Follow Up. There are three questions: "Have you had any benefit from your treatment?" (Yes/No) "Taking all things into account, are you satisfied with your treatment?" (Yes/No) "Would you be willing to continue treatment with this therapy (Yes/No). Total scores range from 0-3 and greater total scores indicate greater satisfaction with treatment.
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)]
Peak exertion on the 6-minute arm test measured by a physical therapist assisting the participant with the exercise. Self-reported scores range from 6-20, and higher scores indicate greater physical exertion.
Leisure Time Physical Activity (LTPA) [Treatment Completion (week 4), 6 Month Follow Up (week 24)]
Self-reported mild to vigorous physical activity in the past week, reported as minutes per week and number of days per week of mild to vigorous physical activity. Greater total minutes and total days indicate more physical activity.
Patient Health Questionnaire (PHQ-9) [Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)]
Self-reported depression in the past week measured using a 9-item validated survey. Responses range from '0' (not at all) to '4' (nearly every day). Total scores range from 0-36 and higher total scores indicate worse depression.
Generalized Anxiety Disorder (GAD-7) [Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)]
Self-reported anxiety in the past week measured using a 7 item validated survey. Responses range from '0' (not at all) to '4' (nearly every day). Total scores range from 0-36 and higher total scores indicate worse anxiety.
Patient Reported Outcome Measures Information System (PROMIS) Fatigue Short Form [Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)]
Self-reported fatigue measured using a 4-item validated survey. Responses range from '0' (not at all) to '4' (very much). Total scores range from 0-16, with higher scores indicating worse fatigue.
Numerical Rating Scale (NRS) of Worst/Average Pain [Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)]
Self-reported worst and average pain in the past 7 days, rated from '0' (no pain) to '10' (pain as bad as you can imagine)
Wheelchair Users Shoulder Pain Inventory (WUSPI) [Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)]
Self-reported shoulder pain in the past week measured on a 10-point Likert scale from '0' (no pain) to '10' (worst pain ever experienced). Total scores range from 0-150 with greater total scores indicating greater pain.
Physical Activity Enjoyment Scale (PACES) [Within 5 minutes after each Sprint Interval Training session during first 3 weeks of study (weeks 0-3)]
Self-reported exercise enjoyment measured on a 7-point likert scale ranging from '0' (I hate it) to '7' (I enjoy it). Total scores range from 0-7 with greater scores indicating greater exercise enjoyment.
Spinal Cord Injury Exercise Self-Efficacy [Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)]
Self-reported exercise self-efficacy measured on a 4-point Likert scale from '0' (not true at all) to '4' (always true). Total scores range from 0-40, with greater scores indicating greater sense of self-efficacy.
SCI Quality of Life [Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24)]
Self-reported quality of life measured on a 10-point Likert scale using the International SCI Data Sets Quality of Life Basic Data sets survey, which has a 10-point Likert scale from '0' (Completely dissatisfied) to '10' (Completely satisfied). Total scores range from 0-30 with greater total scores indicating higher quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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