Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury: Physical Activity, Healthy Diet and Maintenance After Discharge.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- VO2peak
研究概览
简要总结
This study is a controlled pragmatic implementation study in clinical practice, with a primary focus on cardiovascular risk reduction through adherence to behavioral interventions related to physical activity and healthy diet.The intervention is interdisciplinary, multimodal and patient activating and uses the existing setting and work flows at the clinic, ensuring that the patients receive education about cardiovascular risk factors, physical activity and healthy diet through a systematic approach including targeted patient education.
详细描述
This clinical intervention study will investigate the effectiveness of a uniform and systematic institutional strategy incorporating targeted strategic patient education about cardiovascular risk factors, physical activity and a healthy diet lifestyle starting early in the primary rehabilitation process with 6 months of follow up compared to a historic control group. Test - retest reliability of four different VO2 peak tests and a multi sensor accelerometer respectively will be assessed as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •All newly injured patients (within the last 12 months) with Spinal Cord Injury admitted at Clinic for Spinal Cord Injuries, Rigshospitalet.
排除标准
- •Insufficient skills in Danish language
- •Reduced mental function that prevents reading and answering the questionnaires
结局指标
主要结局
VO2peak
时间窗: Assessing change from admission to discharge in average 4-6 months after admission and follow up 6 months after discharge
Measures peak oxygen consumption in ml/kg/min
次要结局
- Triglycerides(At follow up 6 months after discharge)
- HemoglobinA1c(At follow up 6 months after discharge)
- Body Mass Index(At follow up 6 months after discharge)
- The 9-item Shared Decision Making Questionnaire (SDM-Q-9)(At discharge in average 4-6 months after admission)
- The Exercise Self Efficacy Scale for people with Spinal Cord Injury(At follow up 6 months after discharge)
- Blood pressure(At follow up 6 months after discharge)
- Cholesterol(At follow up 6 months after discharge)
- International Standards for Neurological Classification of Spinal Cord Injury(At follow up 6 months after discharge)
- Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury(At follow up 6 months after discharge)
- Dual energy x-ray absorbtiometry (Dexa)(At follow up 6 months after discharge)
- C - reactive protein (CRP)(At follow up 6 months after discharge)
研究者
Nicolaj Jersild Holm
Principal investigator
Rigshospitalet, Denmark