Feasibility of the First Known Adaptive Intervention for People With SCI
NCT ID: NCT04726891
Last Updated: 2024-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
36 participants
INTERVENTIONAL
2022-06-26
2023-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Design and Delivery Preferences for Exercise Intervention in People With Spinal Cord Injury
NCT06578780
A Lifestyle Intervention Targeting Enhanced Health and Function for Persons With Chronic SCI in Caregiver/Care-Receiver Relationships: Effects of Caregiver Co-Treatment
NCT02853149
Exercise for People with Spinal Cord Injury
NCT04007445
Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
NCT05870189
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
NCT05542238
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A sample of individuals with SCI will be randomized to 3 weeks or 6 weeks of M2M with social networking support for the first treatment stage. Depending on adherence, they will either continue with the intervention received in the first treatment stage or be randomized a second time. Specifically, participants with high adherence (40 or more minutes) will continue M2M with social networking support, while those with low adherence (less than 40 minutes) will be randomized to an augmented arm that includes individualized behavioral coaching or to an arm that switches to M2M Live. The second treatment stage will last until the participant has completed a total of 12 weeks on the program. The social networking support, individualized behavioral coaching, and M2M Live sessions will be completed through secure videoconferencing on the mobile health platform, which will allow a singular location for tracking intervention activity. All security features of the integrated videoconferencing software will be used, including passwords and waiting rooms.
M2M. In the first treatment stage, all participants will receive M2M as the evidence-based home exercise intervention. M2M is provided in the form of an exercise routine that includes aerobic and strength training set to music. Each week the participants will receive a set of exercise videos, which they will be asked to complete 3 times during the week. Exercise videos begin with a low dose of minutes, approximately 10 to 15 minutes for a total of 40 minutes for the week, and increase by 3-5 minutes each week.
Social Networking Support. In the first treatment stage, all participants will also receive social networking support. The group will also be able to communicate through the mobile health platform via features such as messaging, posting, commenting, and liking. Each week a discussion board will provide an opportunity for participants to post comments concerning the week's exercise content, weekly article, and/or their experience with the program that week.
Individual Behavioral Coaching. Some participants with sub-optimal adherence in the first treatment stage will be randomized to one of two treatment groups in the second treatment stage. Half of these participants will receive M2M plus social networking support augmented with individualized behavioral coaching.
M2M Live. The remaining half of participants with sub-optimal adherence in the first treatment stage will switch to another M2M-based home exercise intervention, M2M Live. This involves one-on-one tele-exercise training with an M2M instructor. During the first week of M2M Live, the participant will set a schedule to meet with the M2M instructor one time per week for an exercise session. The exercise session will be recorded and posted for the participant to complete 2 additional times.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Continued M2M + SNS for 9 weeks
Participants who successfully watch and exercise at or above 40 minutes per week will continue doing M2M + SNS for the remaining 9 weeks of the study.
Movement-2-Music + Social Networking Support
The primary goal of the proposed research is to conduct a 12-week pilot study of the SMART-HEALTH intervention in 30 individuals with SCI. There are several unique features of this study design, including a novel adapted exercise program (M2M), instructor-led, individualized training (M2M Live; described in D.2.1), individualized behavioral coaching, and social networking support.
Augmented M2M + SNS + IBC for 9 weeks
Some participants with sub-optimal adherence in the first treatment stage will be randomized to one of two treatment groups in the second treatment stage. these participants will receive M2M plus social networking support augmented with individualized behavioral coaching. Individualized behavioral coaching involves a weekly coaching session to improve self-regulatory skills based on prior and individualized exercise prescription. The exercise prescriptions are determined by the coach and individual based on their current activity level and a 4-week goal. An example of tailoring the exercise prescribed involves setting a goal of completing the exercise routine one time for the upcoming week instead of three times. The coach will be trained in motivational interviewing to help the participant modify their exercise habits.
Movement-2-Music + Social Networking Support
The primary goal of the proposed research is to conduct a 12-week pilot study of the SMART-HEALTH intervention in 30 individuals with SCI. There are several unique features of this study design, including a novel adapted exercise program (M2M), instructor-led, individualized training (M2M Live; described in D.2.1), individualized behavioral coaching, and social networking support.
Switched M2M Live for 9 weeks
The remaining half of participants with sub-optimal adherence in the first treatment stage will switch to another M2M-based home exercise intervention, M2M Live. M2M Live involves one-on-one tele-exercise training with an M2M instructor, which provides accountability and immediate, tailored feedback along with custom movements and music. During the first week of M2M Live, the participant will set a schedule to meet with the M2M instructor 1 time each week for an exercise session. The M2M Live instructors are also trained in motivational interviewing in order to coach participants through any barriers to changing their exercise behavior.
Movement-2-Music + Social Networking Support
The primary goal of the proposed research is to conduct a 12-week pilot study of the SMART-HEALTH intervention in 30 individuals with SCI. There are several unique features of this study design, including a novel adapted exercise program (M2M), instructor-led, individualized training (M2M Live; described in D.2.1), individualized behavioral coaching, and social networking support.
Continued M2M + IBC for 6 weeks
Participants who successfully watch and exercise at or above 40 minutes per week will continue doing M2M + SNS for the remaining 6 weeks of the study.
Movement-2-Music + Social Networking Support
The primary goal of the proposed research is to conduct a 12-week pilot study of the SMART-HEALTH intervention in 30 individuals with SCI. There are several unique features of this study design, including a novel adapted exercise program (M2M), instructor-led, individualized training (M2M Live; described in D.2.1), individualized behavioral coaching, and social networking support.
Augmented M2M + SNS + IBC for 6 weeks
Some participants with sub-optimal adherence in the first treatment stage will be randomized to one of two treatment groups in the second treatment stage. these participants will receive M2M plus social networking support augmented with individualized behavioral coaching. Individualized behavioral coaching involves a weekly coaching session to improve self-regulatory skills based on prior and individualized exercise prescription. The exercise prescriptions are determined by the coach and individual based on their current activity level and a 4-week goal. An example of tailoring the exercise prescribed involves setting a goal of completing the exercise routine one time for the upcoming week instead of three times. The coach will be trained in motivational interviewing to help the participant modify their exercise habits.
Movement-2-Music + Social Networking Support
The primary goal of the proposed research is to conduct a 12-week pilot study of the SMART-HEALTH intervention in 30 individuals with SCI. There are several unique features of this study design, including a novel adapted exercise program (M2M), instructor-led, individualized training (M2M Live; described in D.2.1), individualized behavioral coaching, and social networking support.
Switched M2M Live for 6 weeks
The remaining half of participants with sub-optimal adherence in the first treatment stage will switch to another M2M-based home exercise intervention, M2M Live. M2M Live involves one-on-one tele-exercise training with an M2M instructor, which provides accountability and immediate, tailored feedback along with custom movements and music. During the first week of M2M Live, the participant will set a schedule to meet with the M2M instructor 1 time each week for an exercise session. The M2M Live instructors are also trained in motivational interviewing in order to coach participants through any barriers to changing their exercise behavior.
Movement-2-Music + Social Networking Support
The primary goal of the proposed research is to conduct a 12-week pilot study of the SMART-HEALTH intervention in 30 individuals with SCI. There are several unique features of this study design, including a novel adapted exercise program (M2M), instructor-led, individualized training (M2M Live; described in D.2.1), individualized behavioral coaching, and social networking support.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Movement-2-Music + Social Networking Support
The primary goal of the proposed research is to conduct a 12-week pilot study of the SMART-HEALTH intervention in 30 individuals with SCI. There are several unique features of this study design, including a novel adapted exercise program (M2M), instructor-led, individualized training (M2M Live; described in D.2.1), individualized behavioral coaching, and social networking support.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Wheelchair User
* Able to use arms for exercise
* 18+ years old
* Sedentary (\<60 minutes of exercise/week)
Exclusion Criteria
* Depression (Centers for Epidemiological Studies Depression Scale Score \> 16)
* Poorly controlled blood pressure (SBP \> 159 or DBP \> 95 mmHg)
* Cardiovascular disease event within the past 6 months, severe pulmonary disease, kidney failure
* Active pressure ulcers
18 Years
71 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Craig H. Neilsen Foundation
OTHER
Lakeshore Foundation
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jereme Wilroy
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jereme D Wilroy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lakeshore Foundation
Birmingham, Alabama, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wilroy J, Kim Y, Lai B, Young HJ, Giannone J, Powell D, Thirumalai M, Mehta T, Rimmer J. Increasing Physical Activity in Persons With Spinal Cord Injury With an eHealth-Based Adaptive Exercise Intervention: Protocol for a Sequential Multiple Assignment Randomized Trial. JMIR Res Protoc. 2023 Jul 27;12:e47665. doi: 10.2196/47665.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
645335
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
645335
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.