EaRneST: Exercise and CiRulating MetabolomicS: A Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Metabolmic Profile
研究概览
简要总结
Brief Summary The purpose of this study is to investigate how circulating metabolites mediate changes in heart function after exercise intervention.
Condition or disease :Cardiovascular function
Intervention/treatment Cardiovascular: Echocardiography Other: Vascular Stiffness Other: Metabolomics (Blood)
详细描述
Detailed Description The purpose of the study is to determine the effect of a structured exercise intervention on mitochondrial fuel metabolism and cardiovascular function. Participants with diastolic dysfunction will undergo a structured exercise intervention.
Group A (intervention) will undergo exercise intervention for three months and Group B (control) will not receive the exercise intervention. At the start of the study and upon completion, all participants will undergo cardiovascular tests to measure cardiovascular function, as well bio-specimen (blood and urine) collection for metabolic profiling.
Study Design Study Type : Randomized controlled trial Estimated Enrollment :40 participants Time Perspective:Prospective Official Title:EaRneST: Exercise and CiRculating MetabolomicS: A Pilot Randomized Controlled Study Study Start Date :July 2018 Estimated Primary Completion Date :Nov 2019 Estimated Study Completion Date : Nov 2019
Groups and Cohorts Group/Cohort :Group A Intervention/treatment Visit 1. Baseline procedures
- Cardiovascular measurements Arterial stiffness assessment by non-invasive brachial blood pressure machine Echocardiography Standard transthoracic echocardiographic examination will be performed according to established laboratory practice using standard commercially available machines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40 years old and above
- •At least Grade 1 Diastolic Dysfunction
- •Willing and able to give informed consent for participation for the study
排除标准
- •History of cardiovascular disease
- •History of cancer
- •History of stroke
- •Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥90mmHg) despite being on treatment for hypertension
- •Low blood pressure (systolic blood pressure <90mmHg or diastolic blood pressure <40mmHg)
- •Acute pulmonary embolus or pulmonary infarction
- •Acute myocarditis or pericarditis
- •Suspected or known dissecting aneurysm
- •Acute systemic infection
- •Uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis or myxedema)
- •Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise
研究组 & 干预措施
Group A - Intervention
Baseline procedure, Bio specimen collection , Six minute walk, Musculoskeletal Analysis, Exercise intervention from Visit 2 to Visit 13, End of 3 month assessment.
干预措施: Group A (Diagnostic Test)
Group B- Control
Baseline procedure, Bio specimen collection , Six minute walk, Musculoskeletal Analysis & End of 3 month assessment.
干预措施: Group A (Diagnostic Test)
结局指标
主要结局
Changes in Metabolmic Profile
时间窗: 3 months
次要结局
未报告次要终点