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

Spinal Cord Injuries Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

• NCT number: NCT05317832
• Study type: Interventional
• Source: Temple University
• Contact: Shivayogi V Hiremath, PhD
• Phone: 2152040496
• Email: shiv.hiremath@temple.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: May 25, 2023
• Completion date: June 30, 2026