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Investigating a Well-being Review in Pulmonary Hypertension

Primary Purpose

Pulmnary Hypertension

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Well-being review and rehabiliation
Qualitative Interviews
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmnary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheffield Teaching Sospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Other

Arm Label

Intervention

Control

Qualitative

Arm Description

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

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.

Outcomes

Primary Outcome Measures

6MWD
Change from Baseline in how far he patient can walk in 6 minutes

Secondary Outcome Measures

Full Information

First Posted
March 23, 2021
Last Updated
April 8, 2021
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04840251
Brief Title
Investigating a Well-being Review in Pulmonary Hypertension
Official Title
Investigating the Feasibility of a Randomised Controlled Trial of a Physiotherapy Well-being Review in Patients With Pulmonary Hypertension.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
COVID
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmnary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will have initial assessments then receive brief advice on exercise. They will also be followed up after 6 months
Arm Title
Qualitative
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Well-being review and rehabiliation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Qualitative Interviews
Intervention Description
Patients who have previously undergone rehabilitation will take part in a semi-structured interview to explore their experience and the impact it has had
Primary Outcome Measure Information:
Title
6MWD
Description
Change from Baseline in how far he patient can walk in 6 minutes
Time Frame
Follow up at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Sheffield Teaching Sospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigating a Well-being Review in Pulmonary Hypertension

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