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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05317832
• Other study ID #: 27338
• Secondary ID: R01HD103904
• Status: Recruiting
• Phase: Phase 2
• Start date: May 25, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2023
• Source: Temple University
• Contact: Shivayogi V Hiremath, PhD
• Phone: 2152040496
• Email: shiv.hiremath[@]temple.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: June 30, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.
• WI Program Reminder
Participants will be provided with reminders to use the WI program
• 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.
• 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.
• 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.
• 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.
• Weekly PA Information
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.
• Daily PA Information
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (8)

Lead Sponsor	Collaborator
Temple University	Albert Einstein Healthcare Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Magee Rehabilitation Hospital, Jefferson Health, Northeastern University, Thomas Jefferson University, University of Alabama at Birmingham, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity recommendations from JITAI	The study will assess if physical activity recommendations from JITAI will lead to (on average) more days of aerobic and strength exercises per week during the WI program. The information whether the participants performed their aerobic and strength exercises will be assessed through an ecological momentary assessment from the mobile-health application.	WI Program (weeks 2-16)
Other	Physical activity recommendations from JITAI	The study will assess if physical activity recommendations from JITAI will lead to (on average) more days of aerobic and strength exercises per week during the physical activity sustainability. The information whether the participants performed their aerobic and strength exercises will be assessed through an ecological momentary assessment from the mobile-health application.	Physical activity sustainability (weeks 17-24)
Other	Feedback about physical activity levels from JITAI	The study will assess if feedback about their physical activity levels from JITAI will lead to (on average) more minutes of aerobic exercise during the WI program. The information whether the participants performed more aerobic exercise will be measured via mobile-health sensor (smartwatch).	WI Program (weeks 2-16)
Other	Feedback about physical activity levels from JITAI	The study will assess if feedback about their physical activity levels from JITAI will lead to (on average) more minutes of aerobic exercise during the physical activity sustainability. The information whether the participants performed more aerobic exercise will be measured via mobile-health sensor (smartwatch).	physical activity sustainability (weeks 17-24)
Other	Age	Age will be assessed as a moderator for Aim 3.	Baseline (week 0)
Other	Sex	Biological sex will be examined as a potential time-invariant moderator for Aim 3.	Baseline (week 0)
Other	Race/ethnicity	Race/ethnicity will be examined as a potential time-invariant moderator for Aim 3.	Baseline (week 0)
Other	American Spinal Injury Association Impairment Scale (AIS)	SCI impairment will be assessed using the American Spinal Injury Association Impairment scale (AIS) from the American Spinal Injury Association.	Baseline (week 0)
Other	SCI and level of injury	SCI and level of injury will be assessed using the SCI Spinal Column Injury Basic Data Set Form.	Baseline (week 0)
Other	Non-traumatic SCI	Non-traumatic SCI will be assessed using the Non-traumatic SCI Data set Version 1.0 Form.	Baseline (week 0)
Other	Functional level of participants	Spinal Cord Independence Measure version III (SCIM III) survey will be used to measure the functional levels of participants. The functional levels of participants is assessed through performance in activities of daily living and mobility.	Baseline (week 0)
Other	Assistive or Mobility device use	Descriptive information about participants using an assistive technology device or mobility device will be collected through an Assistive Mobility Devices and Orthoses Form (survey).	Baseline (week 0)
Primary	Change in moderate-intensity (or higher) physical activity	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 WI program.	Baseline (week 2) and WI Program (week 16)
Primary	Change in moderate-intensity (or higher) physical activity	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.	Baseline (week 2) and physical activity sustainability (week 24)
Primary	Self-reported change in moderate-intensity (or higher) physical activity	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 WI program.	Baseline (week 2) and WI Program (week 16)
Primary	Self-reported change in moderate-intensity (or higher) physical activity	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.	Baseline (week 2) and physical activity sustainability (week 24)
Primary	Self-reported change in moderate-intensity (or higher) leisure time physical activity	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 WI program.	Baseline (week 2) and WI program (week 16)
Primary	Self-reported change in moderate-intensity (or higher) leisure time physical activity	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.	Baseline (week 2) and physical activity sustainability (week 24)
Primary	Change in proximal physical activity	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 WI program among those who are available at the previous randomization decision point.	WI Program (week 2) and WI Program (week 16)
Primary	Change in proximal physical activity	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.	Physical activity sustainability (week 17) and Physical activity sustainability (week 24)
Secondary	Pain level number	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.	Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Secondary	Pain level type	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.	Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Secondary	Fatigue level	The Neuro-QOL Item Bank Version 1.0 Fatigue Short form will allow us to collect fatigue level.	Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)