NCT02598752已完成不适用
Feasibility and Safety of Functional Performance Testing in Patients Undergoing Hematopoietic Cell Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- VO2peak
研究概览
简要总结
The purpose of this study is to see if exercise fitness testing is feasible and safe in persons over 21 years of age who have been diagnosed with a hematological malignancy and are scheduled to undergo a hematopoietic stem cell transplant (HCT). Assessments in this study will look at the capacity of the body before transplantation to see if these measures can help predict how patients do after transplant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with MSK histologically confirmed hematologic malignancy
- •Scheduled for autologous or allogenic HCT at MSKCC
- •≥21 years old
- •ECOG performance status of 0 or 1
- •Completion of baseline CPET
- •Willing to comply with protocol related procedures
排除标准
- •Any of the following absolute contraindications to cardiopulmonary exercise testing
- •Acute myocardial Infarction (within 3-5 days of any planned study procedures)
- •Unstable angina
- •Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- •Recurrent syncope
- •Active endocarditis
- •Acute myocarditis or pericarditis
- •Symptomatic severe aortic stenosis
- •Uncontrolled heart failure
- •Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
- •Thrombosis of lower extremities
- •Suspected dissecting aneurysm
- •Uncontrolled asthma
- •Pulmonary edema
- •Respiratory failure
- •Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
- •Presence of any other concurrent, actively treated malignancy;
- •History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer);
- •Room air desaturation at rest ≤85%
- •Mental impairment leading to inability to cooperate
结局指标
主要结局
VO2peak
时间窗: 1 year
is a measure determined by the CPET
次要结局
未报告次要终点
研究者
研究点 (1)
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