The Effects of the Biodex Sit2Stand Trainer on Function for Individuals With Cardiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Short Physical Performance Battery
研究概览
简要总结
Patients with cardiac disease have been shown to have deficits in activities such as standing up from a chair. The Biodex Sit2Stand Trainer is a new device meant to improve sit to stand performance by providing a lifting force through the seat to help the individual stand. The amount of lift can be graded to help improve leg strength, endurance, and function over time. The device has the potential to be a form of training for those in cardiac rehabilitation who have limitations in standing from a chair.
详细描述
Patients who are diagnosed with cardiovascular disease and enter cardiac rehabilitation present with limitations in activity and restrictions in their abilities to participate in society. Even after a standard course of cardiac rehabilitation, some individuals will still present with deficits. One area this is seen is the ability to stand up from a chair. A new device, the Biodex Sit2Stand Trainer, has been designed to help improve the standing movement in those with lower extremity weakness. The trainer provides a graded lift or push through the seat to help the participant reach a standing posture. This study will whether a six week training program using the trainer will lead to improvements in strength, function and quality of life for those individuals who have recently completed a cardiac rehabilitation program. This study is a pilot study to help determine the ideal dosage of training and identify any limitations in using the device with this population. Based on the results of this pilot work, a larger intervention study will be conducted to examine the effectiveness of the trainer in a cardiac rehabilitation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals nearing the end of their cardiac rehabilitation program will be asked to participate. Inclusion criteria include the following:
- •Completion of a cardiac rehabilitation
- •Ability to walk 50 feet independently with or without an assistive device
- •Inability to stand from a standard chair five times without the use of their arms or unable to complete five sit to stands in less than 15 seconds.
- •No major cardiac arrhythmias during cardiac rehabilitation sessions.
- •Ability to attend 14 sessions over a 7-8 week period
排除标准
- •Not meeting inclusion criteria
研究组 & 干预措施
Intervention
The training protocol will be include 12 sessions completed over six weeks following a periodization training format. Each session will last approximately 40 minutes. At first, training will focus on high volume, low intensity, self-selected velocity with a progression to high intensity, low volume, self-selected velocity ending with a focus on power training (moderate intensity, moderate volume, high velocity movement) over the six weeks of training.
干预措施: Exercise using the Biodex Sit2Stand Trainer (Behavioral)
结局指标
主要结局
Change in Short Physical Performance Battery
时间窗: Week 0 and Week 7
Lower extremity functional assessment tool which include gait speed, sit to stand ability and static balance
次要结局
- Change in HeartQoL(Week 0 and Week 7)
- Change in MacNew(Week 0 and Week 7)
- Change in Six Minute Walk Test(Week 0 and Week 7)
- Change in Isometric knee extension strength(Week 0 and Week 7)
- Change in 10 meter gait speed(Week 0 and Week 7)
研究者
Michael Puthoff
Professor
St. Ambrose University