Remote Exercise Testing in Patients With Pulmonary Hypertension

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Diagnostic test: Exercise Testing

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harrison Stubbs, BMBS; Phone Number: 0141 951 5000; Email: harrison.stubbs@ggc.scot.nhs.uk
• Study Contact Backup: Name: Val Irvine; Phone Number: 0141 951 5000

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G413AU
    • Recruiting
    • Scottish Pulmonary Vascular Unit
    • Contact: Val Irvine; Phone Number: 0141 951 5000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Golden Jubilee National Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 293065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No