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NCT05424172 · ClinicalTrials.gov registry record · NA
Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching
A NA study of Spinal Cord Injuries, sponsored by Shirley Ryan AbilityLab.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05424172: Recruiting NA study of Spinal Cord Injuries, sponsored by Shirley Ryan AbilityLab.
NCT05424172 is a NA study of Spinal Cord Injuries that is actively recruiting participants, run by Shirley Ryan AbilityLab. The registered enrollment target is 50 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (18% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05424172, a NA study of Spinal Cord Injuries, is actively recruiting participants, sponsored by Shirley Ryan AbilityLab.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Using app-based data and self-report, the investigators will determine if each participant met the SCI aerobic exercise guidelines (moderate to vigorous aerobic exercise for at least 20 minutes twice per week) for each week of the study. The investigators will total the number of weeks in which the participants achieved adherence and calculate the percentage of adherence over each 12-week stage. An overall adherence rate of 50% will be regarded as meeting exercise guidelines for the stage.
Conditions Studied
Interventions
- BEHAVIORAL Stage-I, Group 1: Self monitoring using Non-interactive App
- BEHAVIORAL Stage-I, Group 2: Self monitoring using Interactive App
- BEHAVIORAL Stage-II, Groups 1a/2a: E-Coaching 1x per month
- BEHAVIORAL Stage-II, Groups 1b/2b: E-Coaching 2x per month
Study Locations (1)
Illinois
- Shirley Ryan AbilityLab - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-11-02 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
What NCT05424172 shows while recruiting
NCT05424172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (18% lower).
The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 4 interventions - of which Stage-I, Group 1: Self monitoring using Non-interactive App is the first listed.
NCT05424172 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05424172 about?
NCT05424172 is a clinical study titled "Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching". 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 h...
What is the current status of trial NCT05424172?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2022-11-02. Estimated completion is 2026-08-31.
What conditions does trial NCT05424172 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT05424172?
The interventions under investigation include: Stage-I, Group 1: Self monitoring using Non-interactive App (BEHAVIORAL), Stage-I, Group 2: Self monitoring using Interactive App (BEHAVIORAL), Stage-II, Groups 1a/2a: E-Coaching 1x per month (BEHAVIORAL), Stage-II, Groups 1b/2b: E-Coaching 2x per month (BEHAVIORAL).
Who is sponsoring clinical trial NCT05424172?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05424172 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05424172's enrollment target sits among peer trials
50 59th of 202 higher than 141 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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