NCT06477640进行中（未招募）不适用
Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Mean change in cardiac effort
研究概览
简要总结
The purpose of this study is to evaluate whether a home rehabilitation program for patients diagnosed with Pulmonary Arterial Hypertension (PAH) will decrease Cardiac Effort (number of heart beats used during 6-minute walk test/walk distance) and improve quality of life. Ultimately, this information could help improve the management of patients with PAH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Follows at University of Rochester Medical Center Pulmonary Hypertension Clinic.
- •Adult patients (>18 years old) with right heart catheterization confirmed pulmonary hypertension (PAH) on stable vasodilator dosing for at least 30 days. No planned titrations will occur during the 12-week study. If during the study, the treating physician feels it is necessary for safety reasons to adjust dosing, the subject will remain in their assigned group.
- •Access to a smart phone or email to receive daily messages. If patients do not have access to either, we will offer a smartphone with cellular service for use during the study to receive daily messages.
- •Clinically stable by the investigator (i.e., we will not enroll patients who endorse ongoing improvement or clinical worsening at enrollment).
- •The treating investigator (Dr. Lachant or Dr. White) will review the clinical data of an eligible patient and establish them as safe to participate prior to approaching the patient for enrollment (i.e. not in decompensated heart failure or with recurrent pre-syncopal episodes prior to enrollment).
排除标准
- •Pregnancy.
- •Pulmonary Hypertension Groups 2-
- •Resting tachycardia >120 beats/m during screening.
- •Inability to walk.
- •WHO Functional Class IV
- •Lack of access to email or text messaging.
- •Inability to follow daily instructions. including the two home 6-minute walk tests during the initial monitoring period. This is to show compliance with the protocol.
- •Participating in a self-reported rehabilitation or exercise program.
- •Oxygen therapy of more than 6 L/min at rest.
- •Principal Investigator discretion
研究组 & 干预措施
Standard of Care
Placebo Comparator
干预措施: Standard of Care (Behavioral)
Exercise Intervention Group
Experimental
干预措施: Exercise (Behavioral)
结局指标
主要结局
Mean change in cardiac effort
时间窗: baseline to 3 months
Cardiac effort is the number of heartbeats used during the a six minute walk test divided by walk distance
次要结局
- Mean change in six minutes walk distance(baseline to 3 months)
研究者
Daniel Lachant
Assistant Professor
University of Rochester
研究点 (1)
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