Investigating a Well-being Review in Pulmonary Hypertension

Pulmnary Hypertension Clinical Trial

Official title:

Investigating the Feasibility of a Randomised Controlled Trial of a Physiotherapy Well-being Review in Patients With Pulmonary Hypertension.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04840251
• Other study ID #: STH20898
• Status: Withdrawn
• Phase: N/A
• Start date: March 2021
• Est. completion date: May 2023

Study information

• Verified date: April 2021
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmnary Hypertension

Intervention

Other:
• Well-being review and rehabiliation
For their well-being review, patients will meet with a physiotherapist specialist in PH and discuss: how they are what they can do for themselves what it is challenging for them to do how active they are if they have ever exercised before The physiotherapist will then make a referral to the most suitable rehabilitation service local to the patient e.g. rehabilitation classes, physiotherapy at home, weight-loss programmes.
• Qualitative Interviews
Patients who have previously undergone rehabilitation will take part in a semi-structured interview to explore their experience and the impact it has had

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Sospitals NHS Foundation Trust	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6MWD	Change from Baseline in how far he patient can walk in 6 minutes	Follow up at 6 months