Feasibility of a Community-based Exercise Intervention for Persons With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Metabolic Blood Chemistries - Cholesterol Change
研究概览
简要总结
The purpose of the study is to examine the impact of a community-based exercise intervention (CBEI) for persons with spinal cord injury (PwSCI) on physiological and psychological well-being and identify barriers and facilitators to implementation.
详细描述
People with spinal cord injury (PwSCI) are at a greater risk for major health conditions and poorer health outcomes than the population without spinal cord injury. For PwSCI, habitual exercise is critical for both physiological and psychological well-being. Prior research indicates that exercise programs conducted in a controlled setting have positive effects on the physical and psychosocial fitness of PwSCI, but the efficacy and feasibility of these programs are not well understood in community-based settings. The proposed project aims to examine potential health benefits in response to the intervention and identify the barriers and facilitators to successful implementation of a CBEI in PwSCI. The long-term goal of this research is to improve health outcomes of PwSCI by identifying strategies to promote health and support exercise in the community.
The project research aims are to:
- Estimate improvements in physical function, cardio-metabolic health, and psychological well-being of participants enrolled in a CBEI compared to an education-only group.
- Identify barriers, facilitators, and reasons for positive determinants for PwSCI to exercise in a community-based setting.
A single-blind pilot RCT will be conducted. Forty individuals with SCI will be recruited. Each participant will be randomized into either a 12-week CBEI (n=20) or an education control group (n=20). Participants' cardiorespiratory fitness, body composition, metabolic blood chemistries and strength will be assessed pre- (T1) and post- (T2) intervention.
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)
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
- •Diagnosis of SCI
- •18 years or older
- •Have written physician approval to participate in the study
- •Ability to use upper extremities to exercise
- •Participate in < 60 minutes of moderate-intensity exercise per week in the last month
- •Understand English at a sixth-grade level or higher
- •Be able to follow multi-step instructions
- •Independently provide informed consent
- •Willing to participate in three assessments and 36 intervention sessions
排除标准
- •Enrollment in a structured exercise program in the past six months.
- •Have had cardiovascular complications within the past year
- •Currently receive medical treatment for an acute upper extremity injury
- •Have a Stage IV pressure injury
- •Have a cognitive impairment that does not allow them to provide consent or follow multi-step directions.
研究组 & 干预措施
Community-based Exercise Intervention group (CBEI)
A group performing a 12-week guided exercise program at an accessible community health and wellness center
干预措施: Community-based Exercise Intervention group (CBE) (Behavioral)
Exercise Education Control group (EEG)
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
干预措施: Exercise Education Control group (EEG) (Behavioral)
结局指标
主要结局
Metabolic Blood Chemistries - Cholesterol Change
时间窗: Baseline and Up to 4 weeks post interventions
Blood draws will be completed to measure cholesterol levels. Unit of measure will be in mg/dL. Participants will fast 8-10 hours prior to blood draw.
VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)
时间窗: Baseline and Up to 4 weeks post intervention
VO2 peak will be measured using a standard computer-integrated, open-circuit, breath-by-breath metabolic measurement system (TrueOne 2400, Parvo Medics, Sandy UT) while the participant performs a graded-exercise test on an arm crank ergometer (SCIFIT PRO2, Life Fitness, Tulsa, OK). The protocol involves a 3-minute warm-up followed by a standard ramp protocol which is typically completed in 8-12 minutes.
DEXA - Body Composition Overall Body Fat % Change
时间窗: Baseline and Up to 4 weeks post intervention
Participants will then undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety. Body fat % will be the unit of measure.
Metabolic Blood Chemistries - HbA1c Level Change
时间窗: Baseline and Up to 4 weeks post intervention
Blood draws will be completed to measure HbA1c levels in %. Participants will fast 8-10 hours prior to blood draw.
次要结局
- Upper Extremity Strength - Upper Body Strength Change(Baseline and Up to 4 weeks post intervention)
- PROMIS - Fatigue Short Form 8a(Baseline and Up to 4 weeks post intervention)
- PROMIS - Emotional Distress - Depression - Short Form 8a(Baseline and Up to 4 weeks post intervention)
- PROMIS - Pain Intensity - Short Form 3a(Baseline and Up to 4 weeks post intervention)
- PROMIS - Pain Interference - Short Form 8a(Baseline and Up to 4 weeks post intervention)
- PROMIS - Sleep Disturbance - Short Form 8a(Baseline and Up to 4 weeks post intervention)
- PROMIS - Emotional Support(Baseline and Up to 4 weeks post intervention)
研究者
Kerri Morgan
Assistant Professor of Occupational Therapy and Neurology
Washington University School of Medicine