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

Overview

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.

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)]
• Change in moderate-intensity (or higher) physical activity [Time frame: Baseline (week 2) and physical activity sustainability (week 24)]
• Self-reported change in moderate-intensity (or higher) physical activity [Time frame: Baseline (week 2) and WI Program (week 16)]
• Self-reported change in moderate-intensity (or higher) physical activity [Time frame: Baseline (week 2) and physical activity sustainability (week 24)]
• Self-reported change in moderate-intensity (or higher) leisure time physical activity [Time frame: Baseline (week 2) and WI program (week 16)]
• Self-reported change in moderate-intensity (or higher) leisure time physical activity [Time frame: Baseline (week 2) and physical activity sustainability (week 24)]
• Change in proximal physical activity [Time frame: WI Program (week 2) and WI Program (week 16)]
• Change in proximal physical activity [Time frame: Physical activity sustainability (week 17) and Physical activity sustainability (week 24)]

Secondary outcome measures (3)

• Pain level number [Time frame: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)]
• Pain level type [Time frame: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)]
• Fatigue level [Time frame: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Temple University — Philadelphia

Publications

• 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. PMID 38941145

Identifiers

NCT: NCT05317832 · 27338 · R01HD103904

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗