Investigating the Feasibility of a Randomised Controlled Trial of a Physiotherapy Well-being Review in Patients With Pulmonary Hypertension.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- 6MWD
研究概览
简要总结
Pulmonary Hypertension (PH) is a rare disease that makes patients easily become breathless. There is evidence that people with PH can benefit from exercise; we want to look at how they can access rehabilitation in their local community.
Aim: To see if it is feasible to study physiotherapy well-being reviews in PH. Step 1: We will interview some patients with PH who have had rehabilitation and ask questions about their experiences. We will also ask what they think we should measure to show any difference their rehabilitation has made to them. The findings from Step 1 will help us to shape the details of Step 2, where we will conduct a small study to see if it is feasible to run a full study. Participants will be divided randomly into a treatment group and a control group. The treatment group will have a physiotherapy well-being review, leading to referral to their most suitable local rehabilitation service and follow-up after 6 months. The control group will receive brief exercise advice and follow-up after 6 months. The findings will help to design a full study and be shared with patients and health professionals.
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
- 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
- •in World Health Organisation (WHO) Functional Class II or III
- •have a diagnosis of PH
- •have started on PH drug therapy in the preceding 18 months
- •showing no signs of worsening breathlessness or heart failure
- •on an unchanged PH therapeutic regime for at least 6 months prior to inclusion.
排除标准
- •have an active infection or acute exacerbation of lung disease
- •have participated in a clinical study involving another investigation of drug, device or exercise within the previous 6 months
- •are on a surgical or other pathway of care that has pre-determined physiotherapy or activity regimes or restrictions
- •have any additional medical conditions that may adversely affect the safety of the subject or severely limit the lifespan of the subject
- •have participated in rehabilitation in the last 12 months.
结局指标
主要结局
6MWD
时间窗: Follow up at 6 months
Change from Baseline in how far he patient can walk in 6 minutes
次要结局
未报告次要终点