Clinical trial NCT05299463: Remote Exercise Testing in Patients With Pulmonary Hypertension
Official title: Feasibility and Validity of Remote Exercise Testing in Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Hypertension
Lead sponsor: Golden Jubilee National Hospital
Sponsor class: OTHER_GOV
First posted: 2022-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators plan to investigate the feasibility and validity of tests of exercise capacity, when these are performed in hospital and at home, by patients who are diagnosed with pulmonary hypertension.

Patients with pulmonary hypertension develop high blood pressure within the lungs, leading to a limitation in the amount of exercise they are able to perform. At diagnosis and follow-up patients routinely perform short exercise tests which are performed under supervision in the clinic or hospital. The results from these are compared over time and are used to assess how stable patients are. Currently, patients are required to travel to hospital to perform such a test and thus telephone or video appointments do not include this information. This study aims to investigate a range of exercise tests to assess whether they are valid in pulmonary hypertension (whether the results are comparable to the results from the current exercise test performed in hospital, the six-minute walk test) and whether it is feasible for patients to to perform these tests at home.

The investigators aim to investigate four different home exercise tests, including a sit-to-stand test, a timed up and go test, a six-minute walk test and a step test. The investigators will ask patients to perform these tests in a hospital environment and at home on two occasions. The results of these will be compared to see how they change over time and will be compared to other results obtained during standard care. Additionally, patients will be asked a questionnaire to assess their views on the four tests.


Eligibility criteria: Inclusion Criteria:

* Aged 16-years-old and above
* Diagnosed with pulmonary hypertension from any ERS/ESC group
* Able to give informed consent

Exclusion Criteria:

* Unable to provide consent
* Restricted so as unable to perform a standard 6MWT, either due to mobility or symptoms
* Patients feel they would be unable to perform any of the 4 study tests when at home
* Concerns about the patient's safety of performing home-based exercise tests (as decided by the consenting clinician and/or the patient)

Primary outcomes:
measure: Cross-sectional assessment of novel exercise test validity (part 1)
timeFrame: 2 years
measure: Cross-sectional assessment of novel exercise test validity (part 2)
timeFrame: 2 years
measure: Longitudinal study of feasibility
timeFrame: 2 years
measure: Longitudinal study of validity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Scottish Pulmonary Vascular Unit
Study officials:
References: