Investigating a Well-being Review in Pulmonary Hypertension

Not Applicable

Withdrawn

• Conditions: Pulmnary Hypertension
• Interventions: Other: Well-being review and rehabiliation; Other: Qualitative Interviews

• Registration Number: NCT04840251
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03
• Study First Submitted: 2021-03-23
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Study First Posted: 2021-04-09
• Last Update Posted: 2021-04-09
• Primary Completion: 2022-10
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Well-being review and rehabiliation	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
Qualitative	Qualitative Interviews	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.

Primary Outcome Measures

Name	Time	Method
6MWD	Follow up at 6 months	Change from Baseline in how far he patient can walk in 6 minutes

Trial Locations

Locations (1)

Sheffield Teaching Sospitals NHS Foundation Trust; 🇬🇧 Sheffield, United Kingdom