Feasibility of the First Known Adaptive Intervention for People With SCI

Spinal Cord Injuries Clinical Trial

— SMART-HEALTH  

Official title:

Feasibility of the First Known Adaptive Intervention Delivering Innovative Exercise Program Optimized for People With SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726891
• Other study ID #: 645335
• Status: Completed
• Phase: N/A
• Start date: June 26, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 15, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 71 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Lakeshore Foundation	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Lakeshore Foundation, The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Strength	Grip strength	baseline and 12 weeks
Secondary	Respiratory functioning	Peak Expiratory Volume measured by spirometer	baseline and 12 weeks
Secondary	Blood pressure	Two readings prior to exercise using digital blood pressure cuff.	baseline and 12 weeks
Secondary	Heart rate	Two readings prior to exercise using digital blood pressure cuff.	baseline and 12 weeks
Secondary	Physical activity self-efficacy scale	Survey of social cognitive theory construct.	baseline and 12 weeks
Secondary	Outcomes expectations for exercise scale	Survey of social cognitive theory construct.	baseline and 12 weeks
Secondary	demographics	questionnaire including age, sex, race, ethnicity	baseline and 12 weeks
Secondary	sleep disturbance	Secondary health conditions NIH PROMIS	baseline and 12 weeks
Secondary	Depression	Secondary health conditions NIH PROMIS	baseline and 12 weeks
Secondary	Pain intensity	Secondary health conditions NIH PROMIS	baseline and 12 weeks
Secondary	Anxiety	Secondary health conditions NIH PROMIS	baseline and 12 weeks