Spinal Cord Injuries
Conditions
Keywords
spinal cord injuries, physical activity, wearable sensors, mobile health, just-in-time adaptive intervention
Brief summary
The overarching goal of this research study is to evaluate a sensor-enabled, just-in-time adaptive intervention (JITAI) strategy to increase and sustain physical activity levels among individuals with spinal cord injury (SCI) in their communities. A primary objective of this study is to evaluate the integration of a JITAI with a web-based physical activity intervention program. We hypothesize that the integration of web-based physical activity intervention program with JITAI will result in significantly higher physical activity levels compared to the standard web-based physical activity intervention program alone. A secondary objective of this study is to extend existing algorithms that use commercial wearable technology to robustly detect physical activity behaviors to facilitate the delivery of tailored just-in-time actionable feedback and physical activity recommendations for individuals with SCI.
Detailed description
The integration of the JITAI, which provides feedback and physical activity recommendations due to sensor-based assessments of physical activity, with a standard web-based physical activity intervention program will be tested via a clinical trial. Specifically, individuals with SCI will be randomized to web-based physical activity intervention program (WI) or web-based physical activity intervention program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations. Aim 1: Evaluate the efficacy of the WI + JITAI compared to the standard WI alone. We hypothesize that the integration of WI + JITAI will result in significantly higher physical activity levels compared to the standard WI alone. Aim 2: Use a micro-randomized trial design to optimize the delivery of just-in-time physical activity feedback and recommendations in promoting physical activity. Aim 3: Investigate moderators of the effect of WI + JITAI vs. standard WI alone. Moderators will include age, gender, race/ethnicity, level of injury, function, mobility, pain, and fatigue. The proposed study will yield novel insights about JITAIs and JITAIs combined with more traditional, WI programs, which will help researchers design engaging physical activity interventions for individuals with disability in the community that may improve their health and quality of life.
Interventions
BEHAVIORALWI program
This 14-week web-based physical activity intervention (WI) program was developed by the National Center on Health, Physical Activity and Disability. The WI program was developed with guidance from literature and practice in health behavior change and internet-based health promotion programming. The content and features of the WI program include motivational resource, updated weekly resources, and customizable features.
BEHAVIORALWI Program Reminder
Participants will be provided with reminders to use the WI program
BEHAVIORALJITAI Goal Setting
Participants will be provided with standard, tailored, or no goal for the day. The goal will focus on recommending minutes of moderate-intensity (or higher) physical activity and a reminder to perform strength exercises.
BEHAVIORALJITAI physical activity message
Participants will be provided with minutes of moderate-intensity (or higher) physical activity achieved, minutes of physical activity remaining, or no message.
OTHERNotification EMA
Participants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.
OTHEREnd of day EMA
Participants will be inquired, through an ecological momentary assessment (EMA), if they performed aerobic and/or strength exercises for the day.
OTHERWake up time EMA
Participants will be inquired, through an ecological momentary assessment (EMA), about the time they plan to wake up next day. This information will be used to provide a goal setting message for next day.
OTHERWeekly PA Information
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.
OTHERDaily PA Information
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.
Sponsors
Temple University
Northeastern University
University of Alabama at Birmingham
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Good Shepherd Rehabilitation Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
All participants will be provided with the same WI program and mobile health technology. Furthermore, the participants in the WI + JITAI arm will receive randomized prompts of various types of tailored feedback and physical activity recommendations.
Intervention model description
The proposed study is a 24-week longitudinal study that will comprise of 2 weeks of baseline physical activity monitoring, 14 weeks of physical activity monitoring and intervention, and 8 weeks of physical activity monitoring to assess physical activity level sustainability. Individuals with SCI will be randomized to a web-based physical activity intervention (WI) program or a WI program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Participants with SCI will be included if they are: * 18-75 years of age * have a traumatic or non-traumatic SCI (classification of neurological level of injury at cervical level 5 (C5) and below) * are at least 6-months post-SCI * use a manual or a power wheelchair as their primary means of mobility (\>80% of time) * can use their arms to exercise * show readiness to physical activity as assessed by the Physical Activity Readiness Questionnaire * have experience using a smartphone and smartwatch.
Exclusion criteria
Participants will be excluded if they have: * any secondary complications that medically restrict their activity in any way such as cardiovascular disease, pressure injuries, contractures, and infections * are diagnosed with traumatic brain injury.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in moderate-intensity (or higher) physical activity | Baseline (week 2) and WI Program (week 16) | The change in average duration of moderate-intensity (or higher) physical activity, measured via mobile-health sensor (smartwatch that is part of the just-in-time adaptive intervention system - JITAI), between baseline and WI program. |
| Self-reported change in moderate-intensity (or higher) physical activity | Baseline (week 2) and WI Program (week 16) | The change in average duration of moderate-intensity (or higher) physical activity, measured via Physical Activity Recall Assessment for People with Spinal Cord injury (PARA-SCI) survey, between baseline and WI program. |
| Self-reported change in moderate-intensity (or higher) leisure time physical activity | Baseline (week 2) and WI program (week 16) | The change in average duration of moderate-intensity (or higher) physical activity, measured via Leisure Time Physical Activity Questionnaire for People with SCI (LTPAQ-SCI) survey, between baseline and WI program. |
| Change in proximal physical activity | WI Program (week 2) and WI Program (week 16) | The primary analysis for this study will address the question of whether, on average, the feedback and physical activity recommendations from JITAI will have a proximal effect on minutes of physical activity performed over the next 120 minutes during the WI program among those who are available at the previous randomization decision point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain level number | Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24) | The International SCI Pain Basic Data Set Version 2.0 form will allow us to collect the pain level (number) in the participants over the course of the study. |
| Pain level type | Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24) | The International SCI Pain Basic Data Set Version 2.0 form will allow us to collect the types of pain (nociceptive, neuropathic, and other) in the participants over the course of the study. |
| Fatigue level | Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24) | The Neuro-QOL Item Bank Version 1.0 Fatigue Short form will allow us to collect fatigue level. |
Countries
United States
Contacts
CONTACTShivayogi V Hiremath, PhD
PRINCIPAL_INVESTIGATORShivayogi V Hiremath, PhD
Temple University
Outcome results
None listed