Effect of Osteopathy on Pulmonary Function in Patients After Coronary Artery Bypass Graft Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change from baseline in slow vital capacity (SVC) at 12 weeks.
研究概览
简要总结
The purpose of this study is to determine the short and long term effects of osteopathic treatment on pulmonary function, pain and quality of life in patients after coronary artery bypass graft (CABG) surgery. The study is a randomized controlled trial.
详细描述
Coronary artery bypass graft (CABG) surgery is performed worldwide. Several studies have found that there is a decrease in pulmonary function, loss of thoracic mobility and a high prevalence of chronic poststernotomy pain (CPSP) after CABG. So far there is no effective treatment for these conditions. The OstinCare study aims to investigate whether osteopathic treatment has an added value in the treatment of these patients.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned Coronary Artery Bypass Graft (CABG) surgery at the Jessa Hospital Hasselt
- •Planned Endoscopic Atraumatic Coronary Artery Bypass (endo ACAB) surgery at the Jessa Hospital
- •Planned Minimal Invasive Aortic Valve Replacement (mini AVR) surgery at the Jessa Hospital
排除标准
- •Thoracic surgery in the past
- •Redo CABG
- •Complications after CABG, requiring long-term (more than 6 days) admission to intensive care
- •Pathologies of the lungs
- •Pathologies of the heart, other than the coronary artery disease
- •Surgery in the sub diaphragmatic region: epigastric region, left and right hypochondriac region.
结局指标
主要结局
Change from baseline in slow vital capacity (SVC) at 12 weeks.
时间窗: preoperative (baseline) and 12 weeks postoperative
A Slow Vital Capacity (SVC) test will be performed at each time point.
次要结局
- Change from baseline in McNew quality of life questionnaire at 12 weeks.(3 weeks postoperative (baseline) and 12 weeks postoperative)
- Change from baseline in McNew quality of life questionnaire at 52 weeks.(3 weeks postoperative (baseline) and 52 weeks postoperative)
- Change from baseline in slow vital capacity (SVC) at 52 weeks.(preoperative (baseline) and 52 weeks postoperative)
- Change in pain from baseline on Visual Analogue Scale (VAS) at 12 weeks postoperative.(3 weeks postoperative (baseline) and 12 weeks postoperative)
- Change in pain from baseline on VAS at 52 weeks postoperative.(3 weeks postoperative (baseline) and 52 weeks postoperative)
- Change in thoracic stiffness from baseline on VAS at 12 weeks postoperative.(3 weeks postoperative (baseline) and 12 weeks postoperative)
- Change in thoracic stiffness from baseline on VAS at 52 weeks postoperative.(3 weeks postoperative (baseline) and 52 weeks postoperative)
研究者
Roncada Gert
Principal Investigator
Hartcentrum Hasselt