Investigating a Well-being Review in Pulmonary Hypertension
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04840251|
Recruitment Status : Withdrawn (COVID)
First Posted : April 9, 2021
Last Update Posted : April 9, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmnary Hypertension||Other: Well-being review and rehabiliation Other: Qualitative Interviews||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigating the Feasibility of a Randomised Controlled Trial of a Physiotherapy Well-being Review in Patients With Pulmonary Hypertension.|
|Estimated Study Start Date :||March 2021|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||May 2023|
The treatment group will have a physiotherapy well-being review and be referred for rehabilitation. They will be seen after 6 months for follow-up
Other: Well-being review and rehabiliation
For their well-being review, patients will meet with a physiotherapist specialist in PH and discuss:
No Intervention: Control
The control group will have initial assessments then receive brief advice on exercise. They will also be followed up after 6 months
to understand how it feels to take part in the well-being review, we will interview some participants who have already had this kind of treatment and ask questions about their experiences of it and how it was for them. We are also interested to know what differences they felt it made so that we can help to decide about the things we want to measure as outcomes in the interventional of the study.
Other: 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
- 6MWD [ Time Frame: Follow up at 6 months ]Change from Baseline in how far he patient can walk in 6 minutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840251
|Sheffield Teaching Sospitals NHS Foundation Trust|
|Sheffield, United Kingdom, S10 2JF|