Recruiting
Phase 2

Observational Study

Sponsor:

Temple University

Code:

NCT05317832

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

WI program

WI Program Reminder

JITAI Goal Setting

JITAI physical activity message

Notification EMA

Study Details

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

Study ID

NCT05317832

Start date

May 25, 2023

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

196 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Web-based physical activity intervention (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).

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

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.

Interventions

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.

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.

Primary outcome measure

  • Change in moderate-intensity (or higher) physical activity [ Time Frame: Baseline (week 2) and WI Program (week 16) ]
  • Change in moderate-intensity (or higher) physical activity [ Time Frame: Baseline (week 2) and physical activity sustainability (week 24) ]
  • Self-reported change in moderate-intensity (or higher) physical activity [ Time Frame: Baseline (week 2) and WI Program (week 16) ]
  • Self-reported change in moderate-intensity (or higher) physical activity [ Time Frame: Baseline (week 2) and physical activity sustainability (week 24) ]
  • Self-reported change in moderate-intensity (or higher) leisure time physical activity [ Time Frame: Baseline (week 2) and WI program (week 16) ]
  • Self-reported change in moderate-intensity (or higher) leisure time physical activity [ Time Frame: Baseline (week 2) and physical activity sustainability (week 24) ]
  • Change in proximal physical activity [ Time Frame: WI Program (week 2) and WI Program (week 16) ]
  • Change in proximal physical activity [ Time Frame: Physical activity sustainability (week 17) and Physical activity sustainability (week 24) ]

Central Contacts and Locations

Central contacts

Shivayogi V Hiremath, PhD

2152040496shiv.hiremath@temple.edu

Locations

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19121

Contacts

Shivayogi V Hiremath, PhD

215-204-0496shiv.hiremath@temple.edu

Principal Investigator:

Shivayogi V Hiremath, PhD

More Information

Sponsor

Temple University

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2026-06-24.