A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With Spinal Cord Injury.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in Warwick-Edinburgh Mental Well-Being Scale Score reflecting resilience
研究概览
简要总结
The purpose of this study is to examine the effects of onsite and telehealth programs for individuals with spinal cord injury. The primary aim of this study is to compare the effectiveness of a blended 5-day onsite health promotion program followed by a 12-month telehealth package composed of exercise, nutrition, and mindfulness, to a 12-month telehealth-only package in individuals with spinal cord injury. The investigators hypothesize that the blended onsite and telehealth program will achieve better gains in fitness, dietary control, body composition, and pain management scores across a one-year period in comparison to the telehealth-only group. The secondary objective of this study is to examine changes in psychosocial mediators between the two groups to determine if key social cognitive theory constructs were significantly different between the two groups. The investigators hypothesize that the blended onsite and telehealth program will achieve better improvements in these outcomes compared to the telehealth only group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCI ≥ 1 year post injury
- •Able to use arms for exercise
- •18-60 years old
- •Reliable access to the internet
- •Ability to prepare own food, or have input into person responsible for food preparation
- •Can provide own self-care.
排除标准
- •Cognitive impairment
- •Depression
- •Poorly controlled blood pressure (SBP ˃ 159 or DBP ˃ 95 mm HG)
- •Cardiovascular disease event within the past six months
- •Severe pulmonary disease
- •Renal failure
- •Current use of insulin or sulfonylurea agents
- •Current use of medications for psychosis or bipolar disorder
- •Active pressure ulcers
结局指标
主要结局
Change in Warwick-Edinburgh Mental Well-Being Scale Score reflecting resilience
时间窗: Change from baseline to 7 days post baseline to 1 year post baseline.
This scale measures resilience-A person's ability to understand, cope, adapt and strive for a positive balance between gains and losses in health and function across their lifespan.
次要结局
未报告次要终点
研究者
James Rimmer
Principal Investigator
University of Alabama at Birmingham