Safety and Efficacy of Exercise Training Post Burn Injury: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Burns Specific Health Scale - Abbreviated (BSHS-A)
研究概览
简要总结
The purpose of this study is to determine whether a high intensity aerobic and resisted exercise program will improve physical, functional and psychological outcomes in patients post burn injury.
详细描述
Even though immediate and early death from severe thermal injury has reduced over the last twenty years, considerable physical and psychosocial morbidity still persists. While exercise is strongly recommended to assist recovery and overall outcome, there is limited evidence in adults to indicate whether it is effective and/or safe.
This study will investigate the effect of a high intensity aerobic and resisted exercise program exercise program on safety, physical, functional and quality of life measures in adults post burn injury.
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
- Double (Investigator, 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
- •Burns greater than 20% total body surface area
- •18 years of age and over
- •English speaking
- •Post final grafting procedure
排除标准
- •Accompanying anoxic brain injury
- •Cardiac disease or injury (American College of Sports medicine ACSM criteria)
- •Quadriplegia
- •Severe behaviour or cognitive disorders
- •Compassionate care only
结局指标
主要结局
Burns Specific Health Scale - Abbreviated (BSHS-A)
时间窗: Change from baseline to six weeks, change from 6 weeks to 12 weeks
The BSHS-A is an injury specific self reported questionnaire consisting of 80 questions encompassing four primary domains namely physical, psychological, social and general, with reports of good internal consistency, test/ retest reliability and strong convergent validity data.
次要结局
- The modified shuttle walk test (MSWT)(Change from baseline to six weeks, change from 6 weeks to 12 weeks)
- VO2peak (ie the volume of oxygen consumed by the cells at the most intensive level during the exercise test)(Change from baseline to six weeks, change from 6 weeks to 12 weeks)
- Resting heart rate (beats/minute)(Change from baseline to six weeks, change from 6 weeks to 12 weeks)
- Muscle strength(Change from baseline to six weeks, change from 6 weeks to 12 weeks)
- Grip strength(Change from baseline to six weeks, change from 6 weeks to 12 weeks)
- QuickDash(Change from baseline to six weeks, change from 6 weeks to 12 weeks)
- The Lower Extremity Functional Scale (LEFS)(Change from baseline to six weeks, change from 6 weeks to 12 weeks)