The Efficacy of a Supervised Fitness Centre-Based Exercise Programme Compared to an Unsupervised Home-Based Exercise Programme on Improving Fitness and Psychosocial Outcomes in a Traumatic Brain Injured Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:
研究概览
简要总结
The aim of this project is to compare the efficacy of two different fitness exercise programmes on improving fitness and psychosocial functioning in a traumatic brain injured population. We hypothesize that a supervised fitness-centre based exercise programme, compared to an unsupervised home-based exercise programme will show significant improvements in cardiorespiratory fitness, depression and community integration.
详细描述
The objective of this project is to compare a three-month supervised fitness centre-based exercise programme to a 3-month unsupervised home-based exercise programme on discharge from inpatient rehabilitation on improving cardiorespiratory fitness and psychosocial functioning in a traumatic brain injured population. We plan to carry out a multi-centre, assessor blinded, randomised controlled trial with a parallel group design to compare the two interventions. We hypothesise that the supervised fitness-centre based programme will provide significantly better outcomes, and that these gains will not only be evident on completion of the programme, but will be maintained on follow-up, thereby demonstrating that investment in a supervised exercise programme can provide beneficial long-term effects.
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
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have sustained a traumatic brain injury who have completed their inpatient rehabilitation at either of the three Sydney Metropolitan Brain Injury Units (Liverpool, Ryde or Westmead) will be included in this study if they:
- •have sustained a very severe or extremely severe traumatic brain injury
- •have had a hospital admission of > 1 month
- •are able to walk independently at > 1 m/s on discharge
- •are able to commit 3 hours per week to a fitness programme
- •live within the area serviced by the 3 units
排除标准
- •have a concurrent medical condition for which moderate to high intensity exercise is contraindicated
- •are still in Posttraumatic Amnesia (PTA)
- •have cognitive or language problems that affect their ability to understand verbal instructions
- •have behaviour problems not suitable for a fitness centre environment
结局指标
主要结局
Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:
次要结局
- Rate of Perceived Exertion (RPE)
- Hip to Waist ratio
- BICRO-39
- Body Mass Index (BMI)
- Sydney Psychosocial Reintegration Scale (SPRS)
- Depression Anxiety Stress Scales (DASS)
- Profile of Moods Scale (POMS)