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Remote Exercise Testing in Patients With Pulmonary Hypertension

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05299463
Enrollment
100
Registered
2022-03-29
Start date
2021-06-09
Completion date
2024-08-01
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

DIAGNOSTIC_TESTExercise 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).

Sponsors

Golden Jubilee National Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

Exercise study

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Cross-sectional assessment of novel exercise test validity (part 1)2 yearsDuring 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). 1. TUG - time (seconds) 2. T6MWT - distance (metres) 3. STS - number of steps 4. ST - distance (metres) Correlation will be measured by Pearson's R Calculator for parametric data and Spearman's Rho for non-Parametric data.
Cross-sectional assessment of novel exercise test validity (part 2)2 yearsAgreement 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.
Longitudinal study of feasibility2 yearsProportion of patients that completed each of the allocated tests at visit 2 and at visit 3 (3 months after being discharged from hospital).
Longitudinal study of validity2 yearsConcordance 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.

Countries

United Kingdom

Contacts

Primary ContactHarrison Stubbs, BMBS
harrison.stubbs@ggc.scot.nhs.uk0141 951 5000
Backup ContactVal Irvine
0141 951 5000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026