Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
NCT ID: NCT05317832
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
196 participants
INTERVENTIONAL
2023-05-25
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Web-based physical activity intervention (WI) program
Participants in the WI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24).
WI 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.
WI Program Reminder
Participants will be provided with reminders to use the WI program
Weekly PA Information
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.
Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)
Participants in the WI + JITAI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24). In addition, participants will have access to the JITAI that will provide just-in-time feedback and physical activity recommendations (weeks 3 to 24). The type of the feedback and recommendation messages in the WI + JITAI arm will be delivered using micro-randomization, which involves random selection of intervention components at each possible time of delivery.
WI 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.
WI Program Reminder
Participants will be provided with reminders to use the WI program
JITAI 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.
JITAI 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.
Notification EMA
Participants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.
End of day EMA
Participants will be inquired, through an ecological momentary assessment (EMA), if they performed aerobic and/or strength exercises for the day.
Wake 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.
Weekly PA Information
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.
Daily PA Information
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.
Interventions
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WI 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.
WI Program Reminder
Participants will be provided with reminders to use the WI program
JITAI 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.
JITAI 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.
Notification EMA
Participants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.
End of day EMA
Participants will be inquired, through an ecological momentary assessment (EMA), if they performed aerobic and/or strength exercises for the day.
Wake 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.
Weekly PA Information
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.
Daily PA Information
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.
Eligibility Criteria
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Inclusion Criteria
* 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
* are diagnosed with traumatic brain injury.
18 Years
75 Years
ALL
No
Sponsors
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Northeastern University
OTHER
Thomas Jefferson University
OTHER
Magee Rehabilitation Hospital, Jefferson Health
UNKNOWN
University of Alabama at Birmingham
OTHER
University of Michigan
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Good Shepherd Rehabilitation Network
OTHER
Temple University
OTHER
Responsible Party
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Principal Investigators
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Shivayogi V Hiremath, PhD
Role: PRINCIPAL_INVESTIGATOR
Temple University
Locations
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Temple University
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Carey RL, Le H, Coffman DL, Nahum-Shani I, Thirumalai M, Hagen C, Baehr LA, Schmidt-Read M, Lamboy MSR, Kolakowsky-Hayner SA, Marino RJ, Intille SS, Hiremath SV. mHealth-Based Just-in-Time Adaptive Intervention to Improve the Physical Activity Levels of Individuals With Spinal Cord Injury: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 28;13:e57699. doi: 10.2196/57699.
Other Identifiers
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27338
Identifier Type: -
Identifier Source: org_study_id
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