Remote Exercise Testing in Patients With Pulmonary Hypertension

Sponsor

Golden Jubilee National Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05299463

Collaborator

(none)

100

Enrollment

Location

Arm

37.7

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension	Diagnostic Test: Exercise Testing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

Exercise study

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 9, 2021

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Exercise	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).

Arm

Intervention/Treatment

Other: Exercise

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).

Outcome Measures

Primary Outcome Measures

Cross-sectional assessment of novel exercise test validity (part 1) [2 years]
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.
Cross-sectional assessment of novel exercise test validity (part 2) [2 years]
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.
Longitudinal study of feasibility [2 years]
Proportion 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 validity [2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scottish Pulmonary Vascular Unit	Glasgow		United Kingdom	G413AU

Sponsors and Collaborators

Golden Jubilee National Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Golden Jubilee National Hospital

ClinicalTrials.gov Identifier:

NCT05299463

Other Study ID Numbers:

293065

First Posted:

Mar 29, 2022

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension, Pulmonary

Hypertension

Study Results

No Results Posted as of Mar 29, 2022