NCT05317832 · Temple University
Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
WI Program Reminder
Participants will be provided with reminders to use the WI program
BEHAVIORAL
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.
BEHAVIORAL
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.
OTHER
Notification EMA
Participants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.
OTHER
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.
OTHER
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.
OTHER
Weekly PA Information
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.
OTHER
Daily PA Information
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.
Primary outcome measures
Change in moderate-intensity (or higher) physical activity
Time frame: 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.
Change in moderate-intensity (or higher) physical activity
Time frame: Baseline (week 2) and physical activity sustainability (week 24)
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 physical activity sustainability.
Self-reported change in moderate-intensity (or higher) physical activity
Time frame: 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) physical activity
Time frame: Baseline (week 2) and physical activity sustainability (week 24)
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 physical activity sustainability.
Self-reported change in moderate-intensity (or higher) leisure time physical activity
Time frame: 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.
Self-reported change in moderate-intensity (or higher) leisure time physical activity
Time frame: Baseline (week 2) and physical activity sustainability (week 24)
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 physical activity sustainability.
Change in proximal physical activity
Time frame: 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.
Change in proximal physical activity
Time frame: Physical activity sustainability (week 17) and Physical activity sustainability (week 24)
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 physical activity sustainability among those who are available at the previous randomization decision point.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Philadelphia, Pennsylvania
Collaborators
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
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations