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NCT Number: NCT05317832

Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Behavior Central Nervous System Diseases Motor Activity Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Temple University

Philadelphia, Pennsylvania, 19121, United States

Location status: Recruiting

Location contact

Shivayogi V Hiremath, PhD

CONTACT

[email protected]

215-204-0496

Shivayogi V Hiremath, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WI program

Behavioral

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

Behavioral

Participants will be provided with reminders to use the WI program

JITAI Goal Setting

Behavioral

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

Behavioral

Participants will be provided with minutes of moderate-intensity (or higher) physical activity achieved, minutes of physical activity remaining, or no message.

Notification EMA

Other

Participants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.

End of day EMA

Other

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

Other

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

Other

Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.

Daily PA Information

Other

Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. Pain level number

    Time frame: 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.

  2. Pain level type

    Time frame: 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.

  3. Fatigue level

    Time frame: 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.

Other outcomes

  1. Physical activity recommendations from JITAI

    Time frame: WI Program (weeks 2-16)

    The study will assess if physical activity recommendations from JITAI will lead to (on average) more days of aerobic and strength exercises per week during the WI program. The information whether the participants performed their aerobic and strength exercises will be assessed through an ecological momentary assessment from the mobile-health application.

  2. Physical activity recommendations from JITAI

    Time frame: Physical activity sustainability (weeks 17-24)

    The study will assess if physical activity recommendations from JITAI will lead to (on average) more days of aerobic and strength exercises per week during the physical activity sustainability. The information whether the participants performed their aerobic and strength exercises will be assessed through an ecological momentary assessment from the mobile-health application.

  3. Feedback about physical activity levels from JITAI

    Time frame: WI Program (weeks 2-16)

    The study will assess if feedback about their physical activity levels from JITAI will lead to (on average) more minutes of aerobic exercise during the WI program. The information whether the participants performed more aerobic exercise will be measured via mobile-health sensor (smartwatch).

  4. Feedback about physical activity levels from JITAI

    Time frame: physical activity sustainability (weeks 17-24)

    The study will assess if feedback about their physical activity levels from JITAI will lead to (on average) more minutes of aerobic exercise during the physical activity sustainability. The information whether the participants performed more aerobic exercise will be measured via mobile-health sensor (smartwatch).

  5. Age

    Time frame: Baseline (week 0)

    Age will be assessed as a moderator for Aim 3.

  6. Sex

    Time frame: Baseline (week 0)

    Biological sex will be examined as a potential time-invariant moderator for Aim 3.

  7. Race/ethnicity

    Time frame: Baseline (week 0)

    Race/ethnicity will be examined as a potential time-invariant moderator for Aim 3.

  8. American Spinal Injury Association Impairment Scale (AIS)

    Time frame: Baseline (week 0)

    SCI impairment will be assessed using the American Spinal Injury Association Impairment scale (AIS) from the American Spinal Injury Association.

  9. SCI and level of injury

    Time frame: Baseline (week 0)

    SCI and level of injury will be assessed using the SCI Spinal Column Injury Basic Data Set Form.

  10. Non-traumatic SCI

    Time frame: Baseline (week 0)

    Non-traumatic SCI will be assessed using the Non-traumatic SCI Data set Version 1.0 Form.

  11. Functional level of participants

    Time frame: Baseline (week 0)

    Spinal Cord Independence Measure version III (SCIM III) survey will be used to measure the functional levels of participants. The functional levels of participants is assessed through performance in activities of daily living and mobility.

  12. Assistive or Mobility device use

    Time frame: Baseline (week 0)

    Descriptive information about participants using an assistive technology device or mobility device will be collected through an Assistive Mobility Devices and Orthoses Form (survey).

Study contacts

Contact information is provided by the study sponsor or research team.

Shivayogi V Hiremath, PhD

CONTACT

[email protected]

2152040496

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Good Shepherd Rehabilitation Network
  • Northeastern University
  • University of Alabama at Birmingham
  • University of Michigan

Registry information

Official study title

mHealth-based Just-In-Time Adaptive Intervention to Improve Physical Activity Levels of Individuals With Spinal Cord Injury

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 8, 2022
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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