Skip to content

Investigating a Well-being Review in Pulmonary Hypertension

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04840251
Enrollment
0
Registered
2021-04-09
Start date
2021-03-31
Completion date
2023-05-31
Last updated
2021-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmnary Hypertension

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.

Interventions

OTHERWell-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.

OTHERQualitative 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

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
6MWDFollow up at 6 monthsChange from Baseline in how far he patient can walk in 6 minutes

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026