Remote Exercise Testing in Patients With Pulmonary Hypertension
Primary Purpose
Pulmonary Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise Testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Hypertension
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)
Sites / Locations
- Scottish Pulmonary Vascular UnitRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exercise
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05299463
First Posted
June 30, 2021
Last Updated
March 18, 2022
Sponsor
Golden Jubilee National Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05299463
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Golden Jubilee National Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Exercise study
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Exercise Testing
Intervention Description
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).
Primary Outcome Measure Information:
Title
Cross-sectional assessment of novel exercise test validity (part 1)
Description
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.
Time Frame
2 years
Title
Cross-sectional assessment of novel exercise test validity (part 2)
Description
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.
Time Frame
2 years
Title
Longitudinal study of feasibility
Description
Proportion of patients that completed each of the allocated tests at visit 2 and at visit 3 (3 months after being discharged from hospital).
Time Frame
2 years
Title
Longitudinal study of validity
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harrison Stubbs, BMBS
Phone
0141 951 5000
Email
harrison.stubbs@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Val Irvine
Phone
0141 951 5000
Facility Information:
Facility Name
Scottish Pulmonary Vascular Unit
City
Glasgow
ZIP/Postal Code
G413AU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Val Irvine
Phone
0141 951 5000
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Remote Exercise Testing in Patients With Pulmonary Hypertension
We'll reach out to this number within 24 hrs