Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTemple University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
WI program
BehavioralThis 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
BehavioralParticipants will be provided with reminders to use the WI program
JITAI Goal Setting
BehavioralParticipants 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
BehavioralParticipants will be provided with minutes of moderate-intensity (or higher) physical activity achieved, minutes of physical activity remaining, or no message.
Notification EMA
Other interventionParticipants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.
End of day EMA
Other interventionParticipants will be inquired, through an ecological momentary assessment (EMA), if they performed aerobic and/or strength exercises for the day.
Wake up time EMA
Other interventionParticipants 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
Other interventionParticipants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.
Daily PA Information
Other interventionParticipants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.
Treatment groups
196 Participants
are divided into 2 treatment groupsGroup A: Web-based physical activity intervention (WI) programActive comparator 3 interventions
Group B: Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)Experimental treatment 9 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (week 2) and WI Program (week 16)2
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.
Time frame
Baseline (week 2) and physical activity sustainability (week 24)3
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.
Time frame
Baseline (week 2) and WI Program (week 16)4
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.
Time frame
Baseline (week 2) and physical activity sustainability (week 24)Secondary outcomes
1
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.
Time frame
Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)2
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.
Time frame
Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)3
Fatigue level
The Neuro-QOL Item Bank Version 1.0 Fatigue Short form will allow us to collect fatigue level.
Time frame
Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)Other outcomes
1
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.
Time frame
WI Program (weeks 2-16)2
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.
Time frame
Physical activity sustainability (weeks 17-24)3
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).
Time frame
WI Program (weeks 2-16)4
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).
Time frame
physical activity sustainability (weeks 17-24)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Temple University
Lead sponsor
Northeastern University
Collaborator
University of Alabama at Birmingham
Collaborator
University of Michigan
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Good Shepherd Rehabilitation Network
Collaborator
Source ClinicalTrials.gov