Clinical trial NCT05317832: Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
Official title: mHealth-based Just-In-Time Adaptive Intervention to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Spinal Cord Injuries
Keywords: spinal cord injuries
physical activity
wearable sensors
mobile health
just-in-time adaptive intervention
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Northeastern University
name: Thomas Jefferson University
name: Magee Rehabilitation Hospital, Jefferson Health
name: University of Alabama at Birmingham
name: University of Michigan
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Good Shepherd Rehabilitation Network
First posted: 2022-04-08
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in moderate-intensity (or higher) physical activity
timeFrame: Baseline (week 2) and WI Program (week 16)
measure: Change in moderate-intensity (or higher) physical activity
timeFrame: Baseline (week 2) and physical activity sustainability (week 24)
measure: Self-reported change in moderate-intensity (or higher) physical activity
timeFrame: Baseline (week 2) and WI Program (week 16)
measure: Self-reported change in moderate-intensity (or higher) physical activity
timeFrame: Baseline (week 2) and physical activity sustainability (week 24)
measure: Self-reported change in moderate-intensity (or higher) leisure time physical activity
timeFrame: Baseline (week 2) and WI program (week 16)
measure: Self-reported change in moderate-intensity (or higher) leisure time physical activity
timeFrame: Baseline (week 2) and physical activity sustainability (week 24)
measure: Change in proximal physical activity
timeFrame: WI Program (week 2) and WI Program (week 16)
measure: Change in proximal physical activity
timeFrame: Physical activity sustainability (week 17) and Physical activity sustainability (week 24)
Secondary outcomes:
measure: Pain level number
timeFrame: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)
measure: Pain level type
timeFrame: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)
measure: Fatigue level
timeFrame: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Other outcomes:
measure: Physical activity recommendations from JITAI
timeFrame: WI Program (weeks 2-16)
measure: Physical activity recommendations from JITAI
timeFrame: Physical activity sustainability (weeks 17-24)
measure: Feedback about physical activity levels from JITAI
timeFrame: WI Program (weeks 2-16)
measure: Feedback about physical activity levels from JITAI
timeFrame: physical activity sustainability (weeks 17-24)
measure: Age
timeFrame: Baseline (week 0)
measure: Sex
timeFrame: Baseline (week 0)
measure: Race/ethnicity
timeFrame: Baseline (week 0)
measure: American Spinal Injury Association Impairment Scale (AIS)
timeFrame: Baseline (week 0)
measure: SCI and level of injury
timeFrame: Baseline (week 0)
measure: Non-traumatic SCI
timeFrame: Baseline (week 0)
measure: Functional level of participants
timeFrame: Baseline (week 0)
measure: Assistive or Mobility device use
timeFrame: Baseline (week 0)
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Shivayogi V Hiremath, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.