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

Temple University

Status and phase: Enrolling; Phase 2

Conditions: Spinal Cord Injuries

Treatments: Behavioral: JITAI physical activity message; Other: Daily PA Information; Behavioral: JITAI Goal Setting; Behavioral: WI program; Other: Wake up time EMA; Other: End of day EMA; Other: Notification EMA; Other: Weekly PA Information; Behavioral: WI Program Reminder

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05317832

R01HD103904 (U.S. NIH Grant/Contract)

27338

Details and patient eligibility

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. 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.

Full 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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 2 patient groups

Web-based physical activity intervention (WI) program

Active Comparator group

Description:

Participants in the WI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24).

Treatment:

Other: Weekly PA Information

Behavioral: WI Program Reminder

Behavioral: WI program

Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)

Experimental group

Description:

Participants in the WI + JITAI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24). In addition, participants will have access to the JITAI that will provide just-in-time feedback and physical activity recommendations (weeks 3 to 24). The type of the feedback and recommendation messages in the WI + JITAI arm will be delivered using micro-randomization, which involves random selection of intervention components at each possible time of delivery.

Treatment:

Other: Weekly PA Information

Behavioral: WI Program Reminder

Other: Notification EMA

Other: End of day EMA

Other: Wake up time EMA

Behavioral: WI program

Behavioral: JITAI Goal Setting

Other: Daily PA Information

Behavioral: JITAI physical activity message