Cardiopulmonary, Hemodynamic, And Symptom Responses To Aerobic And Resistance Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia: A Single-center, Single-arm Prospective Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in blood pressure in response to aerobic exercise
研究概览
简要总结
The purpose of this study is to assess the cardiopulmonary, hemodynamic, and symptom responses to acute bouts of varying intensity aerobic and resistance exercise in people with Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD), ≥2 months post-event, and free from chest pain.
- •Able to provide written informed consent
排除标准
- •Individuals who are clinically obese (BMI ≥36) and/or who suffer from musculoskeletal or other conditions that would limit exercise participation.
- •Individuals who are deemed medically unstable
- •Participants who are unable to comply with study requirements.
- •Pregnancy
研究组 & 干预措施
Aerobic and resistance exercise
Patients with a history of Spontaneous Coronary Artery Dissection and/or Fibromuscular Dysplasia will undergo three exercise tests.
干预措施: Aerobic and resistance exercises (Behavioral)
结局指标
主要结局
Change in blood pressure in response to aerobic exercise
时间窗: Baseline, 5 minutes, 25 minutes, 50 minutes and 55 minutes
Systemic blood pressure will be measured at rest, at peak exercise, and for 5 minutes of recovery after exercise via finger photoplethysmography and reported as mmHg
Dartmouth COOP Functional Assessment Chart score
时间窗: Baseline
The Dartmouth COOP Functional Assessment Charts are a set of patient-reported, pictorial tools used to measure physical, mental, and social functioning. The tool includes 9 questions that are rated on scores from 1-5, with higher scores indicating worse function.
Duke Activity Index Status (DASI) score
时间窗: Baseline
The Duke Activity Status Index (DASI) is a self-administered questionnaire that measures a patient's functional capacity. It consists of 12 yes/no questions. Scores range from 0 to 58.2, with higher scores indicating better exercise capacity.
International Physical Activity Questionnaire Short Form (IPAQ-SF) score
时间窗: Baseline
The International Physical Activity Questionnaire Short Form (IPAQ-SF) is a 7-item self-reported questionnaire where subjects report time spent being physically active in the last 7 days reported hours per day or minutes per day.
Change in perceived exertion
时间窗: Baseline, 25 minutes, and 50 minutes
Perceived exertion (breathlessness and leg fatigue) will be obtained using the Borg 0-10 scale.
Change in blood lactate concentration [La-]b
时间窗: Baseline, 25 minutes, and 50 minutes
Blood lactate concentration \[La-\]b will be measured via analysis of a pinprick point-of-care lactate test (via the earlobe) at rest, during exercise, and at peak exercise.
次要结局
未报告次要终点
研究者
Elizabeth H. Dineen
Principal Investigator
Mayo Clinic