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

NCT05317832 | Recruiting Phase 2 DMC

• 2 other identifiers: 27338R01HD103904
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injuries; physical activity; wearable sensors; mobile health; just-in-time adaptive intervention

Outcome Measures

Primary Outcomes (8)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (3)

• Pain level number

  Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)

• Pain level type

  Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)

• Fatigue level

  Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)

Other Outcomes (12)

• Physical activity recommendations from JITAI

  WI Program (weeks 2-16)

• Physical activity recommendations from JITAI

  Physical activity sustainability (weeks 17-24)

• Feedback about physical activity levels from JITAI

  WI Program (weeks 2-16)

Study Arms (2)

Web-based physical activity intervention (WI) program

ACTIVE COMPARATOR

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).

Behavioral: WI program; Behavioral: WI Program Reminder; Other: Weekly PA Information

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

EXPERIMENTAL

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.

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

Interventions

WI program BEHAVIORAL

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.

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

WI Program Reminder BEHAVIORAL

Participants will be provided with reminders to use the WI program

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

JITAI Goal Setting BEHAVIORAL

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.

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

JITAI physical activity message BEHAVIORAL

Participants will be provided with minutes of moderate-intensity (or higher) physical activity achieved, minutes of physical activity remaining, or no message.

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

Notification EMA OTHER

Participants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.

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

End of day EMA OTHER

Participants will be inquired, through an ecological momentary assessment (EMA), if they performed aerobic and/or strength exercises for the day.

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

Wake up time EMA OTHER

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.

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

Weekly PA Information OTHER

Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.

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

Daily PA Information OTHER

Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead
• Northeastern University: collaborator
• Thomas Jefferson University: collaborator
• Magee Rehabilitation Hospital, Jefferson Health: 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

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19121, United States

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Shivayogi V Hiremath, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivayogi V Hiremath, PhD

CONTACT

2152040496; shiv.hiremath@temple.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants will be provided with the same WI program and mobile health technology. Furthermore, the participants in the WI + JITAI arm will receive randomized prompts of various types of tailored feedback and physical activity recommendations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed study is a 24-week longitudinal study that will comprise of 2 weeks of baseline physical activity monitoring, 14 weeks of physical activity monitoring and intervention, and 8 weeks of physical activity monitoring to assess physical activity level sustainability. Individuals with SCI will be randomized to a web-based physical activity intervention (WI) program or a WI 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.

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: April 8, 2022
• Study Start: May 25, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The research team will work to make the data available in a reasonable amount of time after its collection and following the acceptance for publication of the main findings. Rules for maintaining and distributing data of Temple University and the NIH will be followed.
• Access Criteria: Requests for data from other scientists will be considered with provision of the following information: A brief description of the specific aims and/or hypotheses, data requirements, proposed analyses, how the data will be used, timeframe for use, and Institutional Review Board (IRB) approvals. Any identifying information in the data will be redacted before sharing. In an effort to provide further protection, parties requesting data will be asked to agree to use the data solely for research purposes, to refrain from identifying participants in any manner, to secure the data electronically through encryption and/or password protection, and to return or destroy the data upon completion of the analyses.

Locations

US (1)