Clinical trial NCT04726891: Feasibility of the First Known Adaptive Intervention for People With SCI
Official title: Feasibility of the First Known Adaptive Intervention Delivering Innovative Exercise Program Optimized for People With SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: exercise
behavioral coaching
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
name: Lakeshore Foundation
First posted: 2021-01-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: sequential multiple assignment randomized trial
Primary purpose: PREVENTION

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).

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 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.

Eligibility 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

Primary outcomes:
measure: Physical Activity
timeFrame: baseline, 4-weeks, 8-weeks, and 12 weeks
Secondary outcomes:
measure: Strength
timeFrame: baseline and 12 weeks
measure: Respiratory functioning
timeFrame: baseline and 12 weeks
measure: Blood pressure
timeFrame: baseline and 12 weeks
measure: Heart rate
timeFrame: baseline and 12 weeks
measure: Physical activity self-efficacy scale
timeFrame: baseline and 12 weeks
measure: Outcomes expectations for exercise scale
timeFrame: baseline and 12 weeks
measure: demographics
timeFrame: baseline and 12 weeks
measure: sleep disturbance
timeFrame: baseline and 12 weeks
measure: Depression
timeFrame: baseline and 12 weeks
measure: Pain intensity
timeFrame: baseline and 12 weeks
measure: Anxiety
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lakeshore Foundation
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jereme D Wilroy, PhD
role: PRINCIPAL_INVESTIGATOR
References: