Feasibility of the First Known Adaptive Intervention for People With SCI (SMART-HEALTH)

• ClinicalTrials.gov Identifier: NCT04726891
• Recruitment Status: Not yet recruiting
• First Posted: January 27, 2021
• Last Update Posted: January 11, 2022
• Sponsor: University of Alabama at Birmingham
• Collaborators: The Craig H. Neilsen Foundation; Lakeshore Foundation
• Information provided by (Responsible Party): Jereme Wilroy, University of Alabama at Birmingham

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries	Behavioral: Movement-2-Music + Social Networking Support	Not Applicable

Detailed Description:

The proposed project aims to address low adherence to exercise interventions among people with SCI. Specifically, we will conduct a 12-week pilot study of a SMART design using a telehealth-delivered intervention previously developed for people with mobility disability as the primary intervention strategy. This intervention, Movement-to-Music (M2M), has been previously packaged as a collection of videos disseminated through an app on a weekly schedule. M2M has been shown to effectively improve physiological outcomes among people with a neurological disability, including SCI. Data collection will include accelerometer-based measurement of physical activity and sleep during the intervention, a 3-day physical activity recall, and assessment of physiological (e.g., grip strength) and psychosocial factors (i.e., depression, anxiety) collected before and after intervention. Social Cognitive Theory has been used successfully in past studies to improve many health behaviors. Thus, it will be utilized into SMART-HEALTH as the following constructs: self-efficacy, self-regulation, social support, and outcome expectations.

A sample of individuals with SCI will be randomized to 4 weeks or 8 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. This includes group discussions, facilitated by project staff trained by the PI in behavioral coaching, about barriers to exercise encountered in the prior week and potential solutions. Sessions will be held weekly in the first month, bi-weekly in the second month, and once in the last month. The group will also be able to communicate through the mobile health platform via features such as messaging, posting, commenting, and liking.

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 3 times a week for an exercise session.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: sequential multiple assignment randomized trial
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Feasibility of the First Known Adaptive Intervention Delivering Innovative Exercise Program Optimized for People With SCI
• Estimated Study Start Date: April 1, 2022
• Estimated Primary Completion Date: January 1, 2023
• Estimated Study Completion Date: April 29, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Continued M2M + SNS for 8 weeks; Participants who successfully watch and exercise at or above 40 minutes per week will continue doing M2M + SNS for the remaining 8 weeks of the study.	Behavioral: 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 Name: Individual Behavioral Coaching; Movement-2-Music Live
Active Comparator: Augmented M2M + SNS + IBC for 8 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.	Behavioral: 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 Name: Individual Behavioral Coaching; Movement-2-Music Live
Active Comparator: Switched M2M Live for 8 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 3 times a 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.	Behavioral: 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 Name: Individual Behavioral Coaching; Movement-2-Music Live
Active Comparator: Continued M2M + IBC for 4 weeks; Participants who successfully watch and exercise at or above 40 minutes per week will continue doing M2M + SNS for the remaining 4 weeks of the study.	Behavioral: 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 Name: Individual Behavioral Coaching; Movement-2-Music Live
Active Comparator: Augmented M2M + SNS + IBC for 4 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.	Behavioral: 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 Name: Individual Behavioral Coaching; Movement-2-Music Live
Active Comparator: Switched M2M Live for 4 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 3 times a 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.	Behavioral: 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 Name: Individual Behavioral Coaching; Movement-2-Music Live

Outcome Measures

Primary Outcome Measures :

1. Physical Activity [ Time Frame: baseline, 4-weeks, 8-weeks, and 12 weeks ]
   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.

Secondary Outcome Measures :

1. Strength [ Time Frame: baseline and 12 weeks ]
   Grip strength
2. Respiratory functioning [ Time Frame: baseline and 12 weeks ]
   Peak Expiratory Volume measured by spirometer
3. Blood pressure [ Time Frame: baseline and 12 weeks ]
   Two readings prior to exercise using digital blood pressure cuff.
4. Heart rate [ Time Frame: baseline and 12 weeks ]
   Two readings prior to exercise using digital blood pressure cuff.
5. Physical activity self-efficacy scale [ Time Frame: baseline and 12 weeks ]
   Survey of social cognitive theory construct.
6. Outcomes expectations for exercise scale [ Time Frame: baseline and 12 weeks ]
   Survey of social cognitive theory construct.
7. demographics [ Time Frame: baseline and 12 weeks ]
   questionnaire including age, sex, race, ethnicity
8. sleep disturbance [ Time Frame: baseline and 12 weeks ]
   Secondary health conditions NIH PROMIS
9. Depression [ Time Frame: baseline and 12 weeks ]
   Secondary health conditions NIH PROMIS
10. Pain intensity [ Time Frame: baseline and 12 weeks ]
    Secondary health conditions NIH PROMIS
11. Anxiety [ Time Frame: baseline and 12 weeks ]
    Secondary health conditions NIH PROMIS

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 71 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• SCI greater than or equal to 1 year after injury
• Wheelchair User
• Able to use arms for exercise
• 18+ years old
• Sedentary (<60 minutes of exercise/week)

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Jereme Wilroy; 205-934-4508; jdwilroy@uab.edu

Locations

United States, Alabama

Lakeshore Foundation

Birmingham, Alabama, United States, 35209

Contact: Jereme Wilroy 205-934-4508 jdwilroy@uab.edu

Principal Investigator: Jereme D Wilroy, PhD

Sponsors and Collaborators

University of Alabama at Birmingham

The Craig H. Neilsen Foundation

Lakeshore Foundation

Investigators

• Principal Investigator: Jereme D Wilroy, PhD; University of Alabama at Birmingham

More Information

• Responsible Party: Jereme Wilroy, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT04726891
• Other Study ID Numbers: 645335
• First Posted: January 27, 2021
• Last Update Posted: January 11, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jereme Wilroy, University of Alabama at Birmingham:

exercise; behavioral coaching

Additional relevant MeSH terms:

Spinal Cord Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries