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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Recruitment Status : Withdrawn (COVID)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
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pulmnary Hypertension Other: Well-being review and rehabiliation Other: Qualitative Interviews Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
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:

  • 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.
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
Qualitative
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


Outcome Measures
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Primary Outcome Measures :
  1. 6MWD [ Time Frame: Follow up at 6 months ]
    Change from Baseline in how far he patient can walk in 6 minutes


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
Sheffield Teaching Sospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04840251    
Other Study ID Numbers: STH20898
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases