Pulmnary HypertensionNCT04840251
Investigating a Well-being Review in Pulmonary Hypertension
A study testing Well-being review and rehabiliation and Qualitative Interviews in people with Pulmnary Hypertension, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmnary Hypertension
- What is being tested?
- Well-being review and rehabiliation and Qualitative Interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Sospitals NHS Foundation Trust
Sheffield, S10 2JF
About this study
Official title: Investigating the Feasibility of a Randomised Controlled Trial of a Physiotherapy Well-being Review in Patients With Pulmonary Hypertension.
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.
- Conditions
- Pulmnary Hypertension
- Being tested
- Well-being review and rehabiliation, Qualitative Interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-being review and rehabiliationOther
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.
Qualitative InterviewsOther
Patients who have previously undergone rehabilitation will take part in a semi-structured interview to explore their experience and the impact it has had
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Other: Well-being review and rehabiliation |
| Control | No intervention | The control group will have initial assessments then receive brief advice on exercise. They will also be followed up after 6 months |
| Qualitative | Other | 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. Receives: Other: Qualitative Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWD
Change from Baseline in how far he patient can walk in 6 minutes
Measured: Follow up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study startMar 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmnary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840251
- Sponsor's protocol ID
- STH20898
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility of a Randomised Controlled Trial of a Physiotherapy Well-being Review in Patients With Pulmonary Hypertension.
- ClinicalTrials.gov ID
- NCT04840251
- Acronym / sponsor ID
- STH20898
- Conditions
- Pulmnary Hypertension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Well-being review and rehabiliationThe treatment group will have a physiotherapy well-being review and be referred for rehabilitation. They will be seen after 6 months for follow-up |
| Control | No intervention | –The control group will have initial assessments then receive brief advice on exercise. They will also be followed up after 6 months |
| Qualitative | Other | Other: Qualitative Interviewsto 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Well-being review and rehabiliationFor 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. | Other | Intervention |
| Qualitative InterviewsPatients who have previously undergone rehabilitation will take part in a semi-structured interview to explore their experience and the impact it has had | Other | Qualitative |
Primary outcome
6MWD
Time frame: Follow up at 6 months
Change from Baseline in how far he patient can walk in 6 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Well-being review and rehabiliation and Qualitative Interviews in people with Pulmnary Hypertension, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWD (time frame: Follow up at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.