Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching
2 other identifiers
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedStudy Start
First participant enrolled
November 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
May 11, 2026
May 1, 2026
3.8 years
June 10, 2022
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of Adherence to SCI exercise guidelines
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.
12 weeks
Rate of Adherence to SCI exercise guidelines
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.
24 weeks
Secondary Outcomes (9)
Change in Six-Minute Walk/Push Test from Baseline to 12 weeks
From Baseline to 12 weeks
Change in Six-Minute Walk/Push Test from 12 to 24 weeks
From 12 weeks to 24 weeks
Change in Six-Minute Walk/Push Test from Baseline to 24 weeks
From Baseline to 24 weeks
Change in Exercise Self-Efficacy from Baseline to 12 weeks
From Baseline to 12 weeks
Change in Exercise Self-Efficacy from 12 to 24 weeks
From 12 weeks to 24 weeks
- +4 more secondary outcomes
Other Outcomes (6)
Change in 10 Meter Walk or Wheelchair Propulsion Test from Baseline to 12 Weeks
From Baseline to 12 weeks
Change in 10 Meter Walk or Wheelchair Propulsion Test from 12 to 24 Weeks
From 12 weeks to 24 weeks
Change in 10 Meter Walk or Wheelchair Propulsion Test from Baseline to 24 Weeks
From Baseline to 24 weeks
- +3 more other outcomes
Study Arms (2)
Stage-I: Self Monitoring Exercise Using a Health App
EXPERIMENTALParticipants will be randomized into one of two groups: Group 1 (self monitoring using a non-interactive app), and Group 2 (self monitoring using an interactive app). Participants in both groups will be provided a customized exercise program to complete over the duration of the study. Within either app, participants will be able to view assigned exercises, log additional exercises completed, complete questionnaires as needed, and access additional resources. Participants will use their own smartphone to receive the health app. Participants will continue using their Stage-I app intervention for the entire duration of the study (weeks 1-24).
Stage-II: Strategy to Address Non-Adherence
EXPERIMENTALAfter 12 weeks, the participants will be categorized as adherents or non-adherents based on their rates of adhering to the SCI exercise guidelines during Stage-I. Non-adherents (those who met the exercise guidelines \<50% of the weeks) will be randomized to receive an augmented intervention of motivational interviewing-based e-coaching (2x per month or 4x per month) in addition to their Stage-I assigned app for 12 weeks (weeks 13-24) to further increase rates of exercise. All non-adherents who will be assigned to the e-coaching interventions will be asked to complete at least daily EMA surveys. A coach who is trained in motivational interviewing will review the EMA data and work collaboratively with participants to identify barriers and facilitators and develop individualized strategies to improve exercise adherence. Adherents (those who met the exercise guidelines \>50% of the weeks) will continue with only their Stage-I assigned app intervention throughout Stage-II.
Interventions
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.
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.
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).
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).
Eligibility Criteria
You may qualify if:
- Individual with diagnosis of SCI, formal or informal caregiver of an individual with an SCI, or clinician that regularly sees individuals with SCI
- years of age
- English-speaking
- Willing to download the study apps
You may not qualify if:
- Severe visual or cognitive problems that would affect the ability to complete the study
- Does not own, or is unable to use a smartphone
- Individual with diagnosis of SCI, complete (only paraplegia) or incomplete, cervical C3- C4 and below
- 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
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2022
First Posted
June 21, 2022
Study Start
November 2, 2022
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
May 11, 2026
Record last verified: 2026-05