Early Initiation of Cardiac Rehabilitation Exercise Training After Sternotomy: A Randomised Controlled Trial and Economic Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Change in Six Minute Walk Test Distance
研究概览
简要总结
The main objective of this trial is to investigate the effects of starting exercise rehabilitation earlier than current practice after coronary artery bypass graft(CABG) or Aortic/Mitral valve replacement (VR) surgery.
详细描述
The trial will compare health improvements after cardiac rehabilitation, (CR) between participants randomly allocated to one of two groups: an early CR group starting exercise after 2 weeks, and a usual care group starting at 6 weeks. It will also collect information on the financial cost of earlier CR to both the health service and the patients.
All primary and secondary outcome measures will be taken at baseline (1 week) and repeated at the start and end of 8 weeks exercise rehabilitation program (2 and 10 weeks from baseline for the early group, 6 and 14 weeks in the usual care group respectively) and at 12 months follow-up.
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 (Outcomes Assessor)
盲法说明
researchers will be blinded during baseline assessment prior to group allocation.
Participants and the clinical CR team will know the group allocation and therefore cannot be blinded. University hospitals for Coventry and Warwickshire NHS trust research and design department will generate the randomisation sequence remotely using permuted block randomisation.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary artery bypass graft, and mitral/aortic valve replacement patients recovering from sternotomy procedure eligible for cardiac rehabilitation
- •Able to provide written informed consent
- •Male or female 18 years of age or greater
排除标准
- •Patients with any of the following:
- •Serious cardiac arrhythmias
- •Current neurological disorders or previous Cerebral Vascular Accident with residual neurological deficit significant enough to limit exercise
- •Enrolled on another clinical trial that involved exercise
- •Unable to enroll for duration of study
- •Patients who are unable to provide written consent.
- •Patients under the age of 18 or over the age of 90.
结局指标
主要结局
Change in Six Minute Walk Test Distance
时间窗: Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Distance walked unassisted in 6 minutes
次要结局
- Euroqol 5 Dimensions Questionnaire(Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.)
- Client Service Receipt Inventory (CSRI) Questionnaire(Early Group- Change between baseline, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 14 weeks post-surgery and 12 months follow-up)
- Combined General Anxiety Disorder (GAD)-7 and Patient Health Questionnaire(PHQ) 9(Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.)
- Five Times Sit to Stand (Timed)(Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.)
- Handgrip Strength(Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.)
- Leg Strength(Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.)
- Short Form (SF) -12 Questionnaire(Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.)