Tele-Exercise to Promote Empowered Movement in Individuals With Spinal Cord Injury, TEEMS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Physical Activity Measure.
研究概览
简要总结
To achieve our specific aims and hypotheses we will conduct a parallel group mixed methods randomized control trial comparing participation in the TEEMS program with exercise via asynchronous video library equivalent (control). The use of mixed methods will allow for the integration of quantitative findings with the qualitative, lived perspective of participants to provide a comprehensive analysis of the tele-exercise program outcomes. All aspects of the study from recruitment, screening, data collection, tele-exercise delivery and team meetings will be virtual to promote access and inclusion by removing barriers and promoting engagement. This study will compare our live group TEEMS program with individual pre-recorded exercise videos. We created TEEMS with the intention of maximizing exercise independence for participants, which decreases need for caregivers during physical activity. The design and participation in TEEMS is meant to increase personal factors that facilitate participation in exercise. These personal factors include confidence and positive associations with exercise. When these personal factors are targeted, individuals with SCI are more likely to participate in physical activity, which supports overall health and QoL.
详细描述
Background: Over half of individuals with spinal cord injury (SCI) report no regular physical activity, a cornerstone for independent function and psychosocial health. Studies confirm comparable prevalence and disruptive impact of SCI inactivity/sedentary lifestyle in the civilian and military community, as well as similar barriers to exercise participation. The proposed study will simultaneously address barriers and promote facilitators of physical activity behavior through expert SCI-specific knowledge, peer mentoring, group cohesion, creating autonomy and self-efficacy, mechanisms of engagement that are relevant across both military and civilian sectors.
Hypothesis/Objectives: Our broad research objective is to determine the effectiveness of a novel group exercise program, (Tele Exercise to promote Empowered Movement with Spinal Cord Injury, TEEMS) that will foster the development of lifelong physical activity behavior by enhancing self-efficacy, specifically as it pertains to exercise. This is facilitated through expert knowledge translation with peer interaction and mentoring. We hypothesize that greater improvements in physical activity participation and psychosocial determinants will be found following participation in TEEMS compared to the control group and will be retained at 16-weeks.
Specific Aims: Aim 1-3 will determine if participation in the synchronous TEEMS program improves psychosocial determinants (self-efficacy, outcome expectations, resilience, kinesiophobia, quality of life) of physical activity behavior (weekly minutes by self-report, wearable activity monitor) and physical factors (pain behaviors, mobility and sleep disturbance) compared to an asynchronous video program (control). Narrative accounts will elaborate on quantitative findings of psychosocial impact of TEEMS participation. Aim 4 will integrate quantitative findings with qualitative, narrative themes of participation in TEEMS to allow for a comprehensive understanding of the impact of group tele-exercise participation compared to an asynchronous video program.
Study Design: We will conduct a randomized control trial using a parallel mixed methods design comparing synchronous participation in the TEEMS program with exercise via asynchronous videos (control). Per the mixed methods design the two distinct datasets (quantitative and qualitative) will be independently collected and analyzed in parallel, with the goal of convergent integration. Data will be collected pre-program, post-program (8-weeks) at retention at 16-weeks. Our novel remotely delivered, synchronous tele-exercise program reduces barriers to access and provides peer support in an inclusive SCI-specific program led by experts in adapted exercise and co-led by individuals living with SCI. Our program conceptual framework is Social Cognitive Theory (SCT), which emphasizes that influencing sociostructural factors and personal determinants will impact health behaviors including physical activity. Each class will be recorded and upon request, participants will be provided access if they choose to perform a class independently. The control group will receive a bank of 16 videos from the previous 8-week session of the tele-exercise program, with a goal of completing 2 videos/week. They will be provided with instructions on progression through the videos and as with the intervention group access as well as ability to access if they choose to perform a class independently. The control group will have weekly communication with the investigative team as well as one-on-one sessions with the leader and co-leader at baseline, week 3 and week 6 to discuss progression and received feedback. All research activities (recruitment, enrollment, communication, data collection, intervention) will be conducted remotely through web-enhanced video systems (Zoom).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
biostatistician
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 12 months post SCI (motor spinal level C5 or below)
- •between 18-75 years of age
- •ability to elevate shoulders >25% range
- •use assistive technology for mobility
- •not currently receiving structured rehabilitation (i.e. new episode of inpatient or outpatient rehabilitation services to treat a new or exacerbated mobility issue. Individuals attending outpatient services for ongoing wellness reasons are eligible to participate).
- •screened and medically cleared (if appropriate) for participation using the American College of Sports Medicine (ACSM) Preparticipation Health Screening Tool. The ACSM Health Screen helps to determine if an individuals should seek a medical referral prior to participation in exercise. The guideline for the screening are based on (1) current exercise participation, (2) history and symptoms of cardiovascular, metabolic, or renal disease, and (3) desired exercise intensity. The algorithm is based on risk stratification and minimizing the barriers of exercise participation by decreasing the number of unnecessary medical referrals.
- •For this study and the safety of participants, those who need a medical referral based on the ACSM preparticipation health screen will be required to provide documentation of medical clearance from their primary medical provider prior to study participation. Dr. York will review screening information and medical clearances to ensure safe inclusion.
- •internet access to attend synchronous exercise classes
排除标准
- •Known or suggestive cardiovascular, metabolic, and/or renal disease and/or presence of absolute or relative contraindications to exercise participation that is considered unsafe by their medical team
- •self-report previous hospitalization within a month,
- •self report active pressure injury
- •self report recent osteoporotic fracture
- •self-report uncorrectable vision loss,
- •self-report preexisting neurological conditions other than SCI
研究组 & 干预措施
Synchronous Group Exercise
All participants will participate in the TEEMS biweekly for 8 weeks (synchronous intervention or asynchronous video library). Participants will participate in the TEEMS biweekly for 8 weeks (synchronous intervention). The synchronous group will attend sessions 2 times per week, with all sessions recorded. The sessions will be 60-minutes total, including 45-minutes of physical activity. Recorded sessions will be made available for participants to use on their own at the end of each week, building a video of 16 videos. The program will be taught by a rehabilitation clinician with expertise in SCI and adapted exercise while our co-instructor will offer peer guidance and demonstrate lived translation of movement with an SCI. Class will take place over a web-based platform (such as Zoom).TEEMS instructors also orient participants to the Borg Rate of Perceived Exertion (RPE, 6-20 scale) to be used as an self-exertion check throughout class and to be recorded in a provided logbook. RPE is u
干预措施: Synchronous Group exercise (Other)
Asynchronous Exercise
The asynchronous control condition will be delivered using a private Youtube playlist. The asynchronous group will be provided with 2 recorded TEEMS videos weekly that align with the synchronous group sessions, building a 16 video library. Participants will participate in the TEEMS biweekly for 8 weeks (synchronous intervention). The asynchronous group will perform sessions 2 times per week. The sessions will be 60-minutes total, including 45-minutes of physical activity.
干预措施: Asynchronous exercise (Control) (Other)
结局指标
主要结局
Physical Activity Measure.
时间窗: baseline (enrollment), 8-weeks, 16-weeks
Physical Activity monitoring: To assess physical activity engagement, mobility function monitoring will be performed by using an activity monitor (GENEActiv) placed on the non-dominant wrist of the individual over a duration of 7 days (matching the duration of the self-report LTPAQ).
Subjective Quality of Life Questionnaire (SQoL)
时间窗: baseline (enrollment), 8-weeks, 16-weeks
This questionnaire is a global measure of subjective perception of QoL. The scale is a Likert-type scale measuring satisfaction with life as a whole: Participants are asked to take everything in their life into account and rate it on an ordinal scale from 1 (life is very distressing; it's hard to imagine how it could get much worse) to 7 (life is great; it's hard to imagine how it could get much better).
Exercise Self Efficacy
时间窗: at baseline (enrollment), 8-weeks, 16-weeks
The SCI Exercise Self-efficacy Scale (ESES).This self-report measures the construct of self-efficacy, or personal beliefs in one's capabilities relating to exercise participation in individuals with SCI. Self-efficacy is cited as the most critical personal factor to behavior change. This outcome demonstrates reliability and high internal consistency.
Exercise Outcome Expectations
时间窗: baseline (enrollment), 8-weeks and 16-weeks
The Multidimensional Outcome Expectations for Exercise Scale (MOEES). This self-report measure addresses physical, social, and self-evaluative components of outcome expectations, another critical element needed for health behavior change. This tool also demonstrates high internal consistency and validity
Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI)
时间窗: baseline (enrollment), one -week, 8-weeks, 16-weeks
The Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) is an SCI-specific, self-report measure of leisure-time physical activity that assesses minutes of mild, moderate, and heavy intensity leisure-time physical activity performed over the previous 7-days. Test-retest reliability and criterion validity of the LTPAQ-SCI has been established. The LTPAQ will be obtained an additional time following participation in the first tele-exercise class.
Qualitative data
时间窗: baseline, 8-weeks
Focus group data collection will be conducted via secure web-based video conferencing platform (Zoom). Data will be obtained at pre-program and post-program (8-weeks). All participants will join focus group interviews of 5-8 individuals that will take approximately 60 minutes pre (baseline) and post- program (8-weeks). Focus groups will be facilitated by a trained team member and co- facilitated by a lived experience class co-instructor . The open-ended guiding questions will be grounded by the numeric outcomes corresponding to measurement constructs and our previous work.
次要结局
- Loneliness (UCLA Loneliness Scale) -(baseline (enrollment), 8-weeks)
- Pain phenomena (SCIQOL-PP)(baseline (enrollment), 8-weeks)
- Self-esteem (SCI-QOL-SE)(baseline (enrollment), 8-weeks)
- Depression (SCI-QOL-DEPR)(baseline (enrollment), 8-weeks)
- Resilience (SCI-QOL-RES)(baseline (enrollment), 8-weeks)
- Participation in Social Roles and Activity (SCI-QOL-PSR)(baseline (enrollment), 8-weeks)
- Satisfaction with Social Roles and Activity (SCI-QOL-SSR)(baseline (enrollment), 8-weeks)
- General Sleep Disturbance Scale(baseline (enrollment), 8-weeks)
研究者
Margaret A. Finley
Associate Professor
Drexel University