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.
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Sheffield, Verenigd Koninkrijk, S10 2JF
- Sheffield Teaching Sospitals NHS Foundation Trust
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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
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For their well-being review, patients will meet with a physiotherapist specialist in PH and discuss:
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Geen tussenkomst: Control
The control group will have initial assessments then receive brief advice on exercise.
They will also be followed up after 6 months
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Ander: 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.
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Patients who have previously undergone rehabilitation will take part in a semi-structured interview to explore their experience and the impact it has had
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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6MWD
Tijdsspanne: Follow up at 6 months
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Change from Baseline in how far he patient can walk in 6 minutes
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Follow up at 6 months
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STH20898
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op Well-being review and rehabiliation
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Christine Kaiser, LAc, DACMWervingVruchtbaarheidsproblemenVerenigde Staten