Clinical trial NCT05764135: SCI-Lynx: A Mobile Platform for Physical Activity Social Support for People With SCI Pilot Study
Official title: SCI-Lynx: A Mobile Platform for Physical Activity Social Support for People With SCI Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injury
Exercise
Physical Activity
Digital Health
Smartphone Application
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2023-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be a total of 50 participants enrolled in the study, 25 will be randomized into the intervention group (SCI-Lynx App) and 25 into the control group (usual care).
Primary purpose: PREVENTION

Brief summary: Physical activity is important to maintain health, fitness, and function in people with spinal cord injury (SCI) and social support is one of the most effective ways to increase physical activity participation. However, a large proportion of people with SCI are physically inactive and do not engage in recreational activities due to environmental and physical challenges. Many people with SCI also experience challenges with social connection, which may make engaging in physical activities more difficult.

The investigators are offering a new online application designed specifically for people with SCI.

The purpose of the research is to develop and evaluate a new online app, called SCI-Lynx, that would allow people with SCI to connect with other people and support each other in their physical activity, exercise, or other health or personal goals over a one-month period. This research will also evaluate how SCI-Lynx affects self-efficacy and social support for exercise and provide new information on changing physical activity participation and social connection in people with SCI.

Detailed description: Physical inactivity or low levels of leisure time physical activity is a concern for individuals with SCI as there are clear benefits for exercise in this special population. Exercise must be sustained to benefit health - the effects are quickly lost when people stop being active. There are several behavioral and other approaches that have been tried to help people adhere to exercise programs.1-4 However, many strategies are not sustained by people over time because people lose interest (i.e. people frequently stop using exercise trackers in the absence of other social support), are not widely accessible or are impractical to scale.

Mobile health applications can be designed to include effective behavioral change strategies to help people develop the skills they need (e.g., goal setting, self-monitoring) to successfully engage in sustained physical activity. A systematic review on effectiveness of mobile apps among healthy people and in those with a range of chronic conditions found statistically significant improvements in health outcomes.5

A systematic review of the most effective strategies to increase adherence to an exercise program include many features that can be integrated into mobile health applications, such as activity tracking, goal setting and social connections.1,6,7 These evidence-based behavioral change approaches can be delivered in many ways, including in-person contact, use of Internet websites, or using printed materials. Mobile health applications, however, have the advantage of allowing users or moderators to reach others remotely at any time and place locally or globally with easy dissemination of information.6,8

While mobile health technology provides an efficient way to deliver behavioral change interventions, uptake, and long-term adherence to mobile applications and/or wearable devices is often low.9 Applications that enable social connections, such as social media networks like Facebook or Instagram, have the largest engagement of any online applications. According to a recent survey, approximately three-quarters of Facebook users and sixty percent of Instagram users visit these sites at least once a day.10 However, websites and networks focused on people with SCI do not currently integrate a social media approach to support physical activity. Mobile Applications that do integrate physical fitness social networks such as Strava are available but focused on non-disabled athletes and are not adapted to meet the different social, emotional, environmental, or physical needs of people with SCI who want to be physically active or gain support for physical activity specific to SCI.11

Eligibility criteria: Inclusion Criteria:

1. Spinal cord injury (SCI) at least 1-year post-injury;
2. . Use a wheelchair (including wheelchairs that are manual, electric or electric scooter) as their primary mobility mode;
3. Greater than 18 years of age; and
4. Able to provide informed consent.

Exclusion Criteria:

1. Not fluent in conversational English;
2. Any health condition that would suggest inability to complete requirements of this study; and
3. Does not have access to computer, tablet, or other device that does not have capability for Zoom video calls or downloading the SCI-Lynx mobile application.

Primary outcomes:
measure: Acceptability and Usability
timeFrame: Follow-up assessments (1 month after randomization)
Secondary outcomes:
measure: National Institutes of Health and Northwestern University Toolbox Item Bank version 2.0- Loneliness (Aged 18+)- Fixed Form
timeFrame: Baseline and the follow-up assessments (1 month after randomization)
measure: Spinal Cord Injury Exercise Self-Efficacy Scale
timeFrame: Baseline and then follow-up assessments (1 month after randomization)
measure: Physical Activity
timeFrame: Baseline and then follow-up assessments (1 month after randomization)
measure: Modified Sallis Social Support for Exercise Survey
timeFrame: Baseline and then follow-up assessments (1 month after randomization)
measure: Adherence
timeFrame: Follow-up assessments (1 month after randomization)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Mass General Brigham
name: Thomas Storer, PhD
role: PRINCIPAL_INVESTIGATOR
References: