Feasibility of the First Known Adaptive Intervention for People With SCI
SMART-HEALTH
1 other identifier
interventional
36
1 country
1
Brief Summary
The overall goal of the proposed research is to conduct a pilot study to test the feasibility and acceptability of a home-based exercise intervention (SMART-HEALTH). The primary purpose of the pilot study is to assess the feasibility of intervention delivery (Aim 1), the acceptability of the intervention by participants (Aim 2) and estimate effect sizes for a future trial (Aim 3).
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 Jun 2022
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
January 21, 2021
CompletedFirst Posted
Study publicly available on registry
January 27, 2021
CompletedStudy Start
First participant enrolled
June 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2023
CompletedJuly 15, 2024
July 1, 2024
1.3 years
January 21, 2021
July 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical Activity
Physical Activity Recall Among people with Spinal Cord Injury (PARA-SCI) Instrument will be used to assess minutes of physical activity. Designed to estimate 3-day summary values for physical activity, including intensity (mild, moderate, or vigorous), duration, and modality (aerobic or strength training), which results in providing total minutes of moderate to vigorous physical activity. The higher number of minutes the better.
baseline, 4-weeks, 8-weeks, and 12 weeks
Secondary Outcomes (11)
Strength
baseline and 12 weeks
Respiratory functioning
baseline and 12 weeks
Blood pressure
baseline and 12 weeks
Heart rate
baseline and 12 weeks
Physical activity self-efficacy scale
baseline and 12 weeks
- +6 more secondary outcomes
Study Arms (6)
Continued M2M + SNS for 9 weeks
ACTIVE COMPARATORParticipants 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.
Augmented M2M + SNS + IBC for 9 weeks
ACTIVE COMPARATORSome 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.
Switched M2M Live for 9 weeks
ACTIVE COMPARATORThe 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.
Continued M2M + IBC for 6 weeks
ACTIVE COMPARATORParticipants 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.
Augmented M2M + SNS + IBC for 6 weeks
ACTIVE COMPARATORSome 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.
Switched M2M Live for 6 weeks
ACTIVE COMPARATORThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- SCI greater than or equal to 1 year after injury
- Wheelchair User
- Able to use arms for exercise
- + years old
- Sedentary (\<60 minutes of exercise/week)
You may not qualify if:
- Cognitive Impairment (Folstein's Mini-Mental State Exam Score \< 24)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- The Craig H. Neilsen Foundationcollaborator
- Lakeshore Foundationcollaborator
Study Sites (1)
Lakeshore Foundation
Birmingham, Alabama, 35209, United States
Related Publications (1)
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.
PMID: 37498650DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jereme D Wilroy, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 21, 2021
First Posted
January 27, 2021
Study Start
June 26, 2022
Primary Completion
October 1, 2023
Study Completion
October 15, 2023
Last Updated
July 15, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share