Physical Capacity Evaluation and Effects of ExerciseTraining on Hodgkin Lymphoma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Physical Capacity - Peak oxygen consumption (mL/kg/min)
研究概览
简要总结
The study aims to investigate if physical capacity obtained in the cardiopulmonary exercise test can predict cardiovascular alterations in Hodgkin Lymphoma (HL) Survivors. In addition, to study the effects of exercise training on physical capacity and cardiovascular responses in these patients.
详细描述
Hodgkin Lymphoma (HL) is a hematological neoplasia that mainly affects young people. Anthracycline-based chemotherapy, followed or not by mediastinal radiotherapy, substantially improves prognosis in this set of patients. Observational studies have shown that cardiovascular disease is the most non oncologic cause of death in this population. Coronary artery disease (CAD) affects 26% of survivors after 10 years of absence of HL . However, the early intervention and the assessment to predict the cardiovascular risk remain little known. In this study, the investigators will test the hypothesis that physical capacity can predict the cardiovascular alterations in HL Survivors. In addition, exercise training improves physical capacity and heart rate responses in this set of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hodgkin Lymphoma Survivors
- •Over 18 years old
- •Chemotherapy with anthracycline and mediastinal radiotherapy in the last 5 years or more
排除标准
- •Renal insufficiency
- •Pregnant women,
- •Iodinated contrast allergy,
- •Life expectancy less than 1 year.
研究组 & 干预措施
Exercise training group
Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
干预措施: Physical Characteristics (Procedure)
Exercise training group
Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
干预措施: Assessment of Heart rate variability (Diagnostic Test)
Exercise training group
Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
干预措施: Blood Pressure and Cardiac Autonomic Control (Diagnostic Test)
Exercise training group
Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
干预措施: Evaluation of Baroreflex Control (Diagnostic Test)
Exercise training group
Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
干预措施: Cardiac Function and Structure (Diagnostic Test)
Exercise training group
Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
干预措施: Assessment of Coronary Anatomy and Calcium Score (Diagnostic Test)
Exercise training group
Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
干预措施: Blood Assessments (Diagnostic Test)
Exercise training group
Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
干预措施: Physical Capacity (Diagnostic Test)
Exercise training group
Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
干预措施: Physical Training (Procedure)
Control Group
Patients will be only clinically followed up. They will not perform exercise training.
干预措施: Physical Characteristics (Procedure)
Control Group
Patients will be only clinically followed up. They will not perform exercise training.
干预措施: Assessment of Heart rate variability (Diagnostic Test)
Control Group
Patients will be only clinically followed up. They will not perform exercise training.
干预措施: Blood Pressure and Cardiac Autonomic Control (Diagnostic Test)
Control Group
Patients will be only clinically followed up. They will not perform exercise training.
干预措施: Evaluation of Baroreflex Control (Diagnostic Test)
Control Group
Patients will be only clinically followed up. They will not perform exercise training.
干预措施: Cardiac Function and Structure (Diagnostic Test)
Control Group
Patients will be only clinically followed up. They will not perform exercise training.
干预措施: Assessment of Coronary Anatomy and Calcium Score (Diagnostic Test)
Control Group
Patients will be only clinically followed up. They will not perform exercise training.
干预措施: Blood Assessments (Diagnostic Test)
Control Group
Patients will be only clinically followed up. They will not perform exercise training.
干预措施: Physical Capacity (Diagnostic Test)
结局指标
主要结局
Physical Capacity - Peak oxygen consumption (mL/kg/min)
时间窗: 4 months
Oxygen consuption in crescent effort will be calculated by aggregation of volume (mL), body weight (Kg) and time (minutes).
次要结局
- Heart Hate (beat/min)(4 months)
- Cardiac Function - Ejection Fraction(4 months)