Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
- Conditions
- Spinal Cord Injuries
- Interventions
- Behavioral: WI programBehavioral: WI Program ReminderBehavioral: JITAI Goal SettingBehavioral: JITAI physical activity messageOther: Notification EMAOther: End of day EMAOther: Wake up time EMAOther: Weekly PA InformationOther: Daily PA Information
- Registration Number
- NCT05317832
- Lead Sponsor
- Temple University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 196
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Web-based physical activity intervention (WI) program WI program 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). Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) Weekly PA Information 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. Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) Daily PA Information 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. Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) Notification EMA 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. Web-based physical activity intervention (WI) program WI Program Reminder 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). Web-based physical activity intervention (WI) program Weekly PA Information 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). Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) JITAI physical activity message 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. Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) WI program 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. Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) Wake up time EMA 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. Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) WI Program Reminder 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. Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) JITAI Goal Setting 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. Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) End of day EMA 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.
- Primary Outcome Measures
Name Time Method Change in moderate-intensity (or higher) physical activity 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.
Self-reported change in moderate-intensity (or higher) physical activity 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.
Self-reported change in moderate-intensity (or higher) leisure time physical activity 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.
Change in proximal physical activity 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 Outcome Measures
Name Time Method Pain level number 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.
Pain level type 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.
Fatigue level 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.
Trial Locations
- Locations (1)
Temple University
🇺🇸Philadelphia, Pennsylvania, United States