SPIRIT Club CBI Pathway: A Novel Streaming Platform for Physical Activity and Wellness Promotion for Chronic Brain Injury Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
Many physical fitness centers and online exercise programs are not designed to support people with intellectual and developmental disabilities. To address this, the investigators are collaborating with SPIRIT Club, a company specializing in fitness for people with disabilities, to improve their platform. The goal is to create a new section of the platform specifically for people with chronic brain injury (CBI). The investigators will test and refine this new section to see how well it works for people with CBI in real-life situations. The research will focus on conducting a study with 60 people who have CBI to see if the new section helps them be more active and confident in their ability to exercise. Half will use the new section, and the other half will just be monitored for their activity. The investigators includes experts in fitness and rehabilitation for people with disabilities from industry, clinical settings, and research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigators operationally define 'Outcomes Assessor' for this trial as the biostatistician, who will be unaware of participant group assignments during the final data analysis.
The data for key outcomes, such as feasibility and acceptability, are generated directly by the participants themselves through their survey responses and interaction with the platform.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older with chronic brain injury (CBI)
- •At least 9 months post-injury
- •Is able to able to be able to demonstrate the ability to meet at least one of the following functional mobility scenarios: 1) able to walk with or without an assistive device or with no more than contact guard assist from a caregiver for steadiness checks and proprioceptive support, 2) able to stand up from a chair with no assistance or no more than contact guard assist from a caregiver for steadiness and proprioceptive support, and/or 3) able to maintain steady seated balance in a chair or wheelchair and able to lift at least one limb with minimal assist (<25%) from a caregiver against gravity
- •Currently exercising less than 60 minutes per week
- •Able to follow simple commands
- •Participant is his/her own legal authorized representative (LAR) or LAR is able to verify they can follow simple commands and participate in study and support consenting and participation processes
- •Provides confirmation of medical clearance from physician to participate in moderate levels of activity without supervision from a licensed healthcare provider
排除标准
- •Unsafe independent functional mobility observed during the functional mobility screen and no available caregiver/carepartner to facilitate participation in the study and provide assistance while using the SPIRIT Club platform
- •Being advised by any healthcare provider to avoid or restrict participation in moderate to high-intensity physical activity
- •Uncontrolled blood pressure, unstable angina, severe joint disease, uncontrolled or untreated dizziness or vertigo, or other medical issue precluding exercises leading to lack of clearance from a physician
- •Unable to follow simple commands or persistent post-traumatic amnesia
- •Presence of expressive aphasia
- •Lack of fluency in English
- •Unable to follow simple commands or persistent post-traumatic amnesia
- •Regular participation (2 or more days per week) in a structured fitness program or platform (e.g., group exercise classes or personal training)
- •Regular participation (average of 1 or more days per week) in physical therapy services specifically for brain injury rehabilitation
研究组 & 干预措施
Activity Monitoring Only
There is no intervention in this Arm. In order to track activity, participants will undergo the same activity monitoring procedures as the experimental group.
SPIRIT Club CBI Pathway
Participants receive free, two-month access to the SPIRIT Club CBI Pathway on-demand streaming platform, featuring targeted educational modules and adaptive exercise programming designed specifically for CBI survivors and their caregivers, plus a Fitbit Inspire 3 to wear continuously for the purposes of activity monitoring over the intervention period.
干预措施: SPIRIT Club CBI Pathway (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using recruitment rate (number of enrolled participants relative to those approached) as an objective indicator.
Safety of the SPIRIT Club CBI Pathway Platform
时间窗: From enrollment through completion of the intervention (Week 8).
Safety will be assessed through the documentation of exercise-related adverse events (number per participant and total over the intervention period).
Acceptability Survey
时间窗: At program end (Week 8).
Acceptability will be evaluated immediately after the 8-week program or at the time of withdrawal using an electronically administered survey. The investigators will assess acceptability based on answers to a 5-point satisfaction scale (1 = very dissatisfied to 5 = very satisfied) for (1) overall program content and (2) usability and a series of binary yes/no responses to the following questions: "Was the program worth the participant's time?" and "Would the participant recommend it to others with CBI?"; and open-ended comments capturing likes, dislikes, and improvement suggestions.
Attendance of SPIRIT Club CBI Pathway Sessions
时间窗: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using attendance (number of sessions completed) as an objective indicator.
Attrition Rate
时间窗: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using attrition rate (proportion withdrawing before end of the intervention period as an objective indicator.
Unplanned Study-team contacts during enrollment
时间窗: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using unplanned study-team contacts (number of emails and/or calls outside scheduled check-ins; total and per participant) as an objective indicator.
Accessibility Issues
时间窗: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using accessibility issues (number of instances where participants could not successfully acquire or use the streaming platform or data-collection tools; participant and/or staff team reported) as an objective indicator.
Exercise Self-Efficacy Scale Score
时间窗: Baseline and Week 8
Electronic survey administered to participant. Change in total score on the validated 6-item exercise self-efficacy scale, from baseline to Week 8, which assesses participants' confidence to engage in physical activity despite common barriers.
次要结局
- Daily Activity Log - Tracked Activity Minutes(From enrollment through completion of the intervention (Week 8).)
- Step Count(From enrollment through completion of the intervention (Week 8).)
- Platform Utilization - Minutes of Video Streamed(Weekly summaries during Weeks 1-8.)
- Daily Activity Log - Tracked Activity Counts(From enrollment through completion of the intervention (Week 8))
- Active Minutes(From enrollment through completion of the intervention (Week 8).)
- Platform Utilization - Total Classes Initiated(Weekly summaries during Weeks 1-8.)
研究者
Catherine Quatman-Yates
Associate Professor
Ohio State University