Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Blood pressure response
研究概览
简要总结
The purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Heart Failure Group:
- •Adult 18 years and older.
- •English speaking.
- •Has a qualifying heart failure indication for center-based cardiac rehabilitation.
- •Inclusion Criteria - Healthy Control Group:
- •Adult 18 years and older.
- •English speaking.
- •Absence of pulmonary, cardiovascular, musculoskeletal, neurologic, or orthopedic diseases. Controls will be matched for age and sex.
排除标准
- •HF patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program.
- •Participants unable/unwilling to provide informed consent.
- •Uremia, history of allergy to iodides. Impaired renal function.
- •Creatinine value greater than 1.3 mg/dL (via clinical record within the past 6 months).
- •Diagnosis of liver disease.
研究组 & 干预措施
Sham arm
Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.
干预措施: Inspiratory muscle training (Device)
Non-sham arm
Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.
干预措施: Inspiratory muscle training (Device)
结局指标
主要结局
Blood pressure response
时间窗: baseline and 12 week follow up
Mean arterial pressure
Change in blood flow response
时间窗: baseline and 12 week follow up
respiratory muscle blood flow
Change in limb vascular resistance response
时间窗: baseline and 12 week follow up
Limb vascular resistance
次要结局
未报告次要终点
研究者
Joshua R. Smith
Principal Investigator
Mayo Clinic