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Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 11, 2026 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Interventions: Stage-I, Group 1: Self monitoring using Non-interactive App (Behavioral), Stage-I, Group 2: Self monitoring using Interactive App… to Stage-I, Group 1: Self monitoring using Non-interactive App (Behavioral), Stage-I, Group 2: Self monitoring using Interactive App…
    • Eligibility criteria expanded, about 33 words
    v6
  3. Eligibility criteria revisedv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 15, 2022 to Nov 2, 2022
    v4
  5. Start date: Jul 15, 2022 to Nov 15, 2022v3
  6. Secondary endpoints: details revised at 9 of 9 entries
    • Study description revised
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this research is to increase physical activity among individuals with a spinal cord injury (SCI) through a customized, interactive smartphone-based health app and e-coaching using three phases: (1) leading focus groups of potential app users and clinicians to gain information regarding health apps preferences for optimal consumer use, (2) conducting a usability study of the customized app to determine the quality and implement further changes for optimization, and (3) conducting a sequential multiple assignment randomized trial (SMART) to determine the most effective adaptive intervention to improve exercise adherence. A SMART trial will be used to determine when and how to adapt dosage, timing, and delivery to increase adherence and address low-response behaviors. In Stage-I, the investigators will compare outcomes among participants using a generic, non-interactive exercise app (Group 1) to a customized, interactive app that can gain information through frequent Ecological Momentary Assessments (EMA) that will be used to modify each participant's exercise programs (Group 2). After 12 weeks, participants who are not meeting the exercise guidelines at least 50% of the time will also be asked to participate in motivational interviewing-based e-coaching either two or four times per month in addition to their originally assigned intervention (Stage-II). By completing these three phases, this project addresses deficiencies in exercise levels and compliance by implementing an individualized exercise prescription, an adaptive intervention for low responders, a way to address barriers to exercise, and a free smartphone app for broad implementation.
Trial Details
NCT Number NCT05424172
Lead Sponsor Shirley Ryan AbilityLab
Conditions
(from sponsor)		 Spinal Cord Injuries
Related terms Motor Activity, Spinal Cord Injuries
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov