NCT05424172 · Shirley Ryan AbilityLab
Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching
What this study is about
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 randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Stage-I, Group 1: Self monitoring using Non-interactive App
Participants in Group 1 will have minimal features that affect compliance (notifications, rewards, EMA, etc.) and no modifications to their exercise program after initial prescription.
BEHAVIORAL
Stage-I, Group 2: Self monitoring using Interactive App
Participants in Group 2 will use the version of the exercise app that has been modified based on the findings from Phases 1 and 2 of this study. Group 2 will be able to use the full features of the interactive app including notifications, ability to submit videos, and non-synchronous messaging/communicating with the researcher. Additionally, participants in Group 2 will be asked to complete 2-5 EMA-based surveys daily to gain information about the participant's barriers and facilitators to exercise. The information from the EMA questionnaires will be used to progress and modify the exercise program at regular intervals for each participant in Group 2.
BEHAVIORAL
Stage-II, Groups 1a/2a: E-Coaching 1x per month
In addition to the Stage-I assigned app, participants will be asked to complete at least daily EMA questionnaires and e-coaching sessions two times a month throughout Stage-II (weeks 13-24). Participants will only receive the augmented e-coaching intervention if they were not adherent to the exercise guidelines for at least 50% of the weeks during Stage-I (weeks 1-12).
BEHAVIORAL
Stage-II, Groups 1b/2b: E-Coaching 2x per month
In addition to the Stage-I assigned app, participants will be asked to complete at least daily EMA questionnaires and e-coaching sessions four times a month throughout Stage-II (weeks 13-24). Participants will only receive the augmented e-coaching intervention if they were not adherent to the exercise guidelines for at least 50% of the weeks during Stage-I (weeks 1-12).
Primary outcome measures
Rate of Adherence to SCI exercise guidelines
Time frame: 12 weeks
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.
Rate of Adherence to SCI exercise guidelines
Time frame: 24 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Individual with diagnosis of SCI, formal or informal caregiver of an individual with an SCI, or clinician that regularly sees individuals with SCI
- 18-80 years of age
- English-speaking
- Willing to download the study apps
Exclusion criteria
- Severe visual or cognitive problems that would affect the ability to complete the study
- Does not own, or is unable to use a smartphone Inclusion Criteria: Phase 2 and 3
- Individual with diagnosis of SCI, complete (only paraplegia) or incomplete, cervical C3- C4 and below
- 18-80 years of age
- English-speaking
- Use a wheelchair as primary means of mobility or walk with or without assistive equipment
- At least 1-year post-SCI
- Not adhering to SCI-specific exercise guidelines as ascertained by self-report or during structured phone interview
- Interested in increasing exercise levels
- Ownership of a smartphone that can be used for the study and has a data plan
- Willing to successfully download and learn to use the study apps
- Able and willing to give written consent and comply with study procedures, including multiple in person follow-up visits Exclusion Criteria: Phase 2 and 3
- Trauma or surgery in the past three months
- An active stage 3 or 4 pressure ulcer
- Medically unstable to perform the home-based exercise as determined by Dr. Chen and his team, the evaluating physical therapist, or the participants' primary care physician.
- Unable to use at least one set of extremities to exercise
- Enrolled in a structured exercise program over the past three months
- Severe visual or cognitive problems that would affect the ability to complete the study
- Does not own, or is unable to use a smartphone
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations