Remote Exercise Testing in Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Feasibility and Validity of Remote Exercise Testing in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05299463
• Other study ID #: 293065
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2022
• Source: Golden Jubilee National Hospital
• Contact: Harrison Stubbs, BMBS
• Phone: 0141 951 5000
• Email: harrison.stubbs[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Diagnostic Test:
• Exercise Testing
Tele-Six-minute walk test (T6MWT) 1 Minute Sit-to-stand test (STS) 2-minute symptom-limited Step test (ST) 3-metre Timed up and go test (TUG).

Locations

Country	Name	City	State
United Kingdom	Scottish Pulmonary Vascular Unit	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Golden Jubilee National Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross-sectional assessment of novel exercise test validity (part 1)	During the inpatient hospital visit (visit 1), correlation will be analysed between the distance (metres) walked on a six-minute walk test and the outcome of each of the study tests (as listed below).; TUG - time (seconds); T6MWT - distance (metres); STS - number of steps; ST - distance (metres) Correlation will be measured by Pearson's R Calculator for parametric data and Spearman's Rho for non-Parametric data.	2 years
Primary	Cross-sectional assessment of novel exercise test validity (part 2)	Agreement will be analysed between each of study tests when performed during visit 1 (inpatient hospital visit) and when performed during visit 2 (within 7 days of being discharged from hospital). This will be performed with Bland-Altman analysis.	2 years
Primary	Longitudinal study of feasibility	Proportion of patients that completed each of the allocated tests at visit 2 and at visit 3 (3 months after being discharged from hospital).	2 years
Primary	Longitudinal study of validity	Concordance of change will be analysed between each of study tests when performed during visit 2 (and when performed during visit 3. This degree of change will be compared against the patients standard six minute walk test result when measured at visit 1 and visit 3.	2 years