Pulmonary HypertensionNCT05299463
Remote Exercise Testing in Patients With Pulmonary Hypertension
A study testing Exercise Testing in people with Pulmonary Hypertension, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Exercise Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jun 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 16-years-old and above
- Diagnosed with pulmonary hypertension from any ERS/ESC group
- Able to give informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Val Irvine contact
United Kingdom1 site, 1 recruiting
- Recruiting
Scottish Pulmonary Vascular Unit
Glasgow, G413AU
Val Irvine, 0141 951 5000
About this study
Official title: 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.
- Conditions
- Pulmonary Hypertension
- Being tested
- Exercise Testing
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TestingDiagnostic test
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | Not described Receives: Diagnostic Test: Exercise Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start9 Jun 2021
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299463
- Sponsor's protocol ID
- 293065
- Status last verified
- Mar 2022
- First submitted
- 30 Jun 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Validity of Remote Exercise Testing in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT05299463
- Acronym / sponsor ID
- 293065
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Diagnostic Test: Exercise Testing |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 16-years-old and above
- Diagnosed with pulmonary hypertension from any ERS/ESC group
- Able to give informed consent
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Diagnostic test | Exercise |
Primary outcome
Cross-sectional assessment of novel exercise test validity (part 1)
Time frame: 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). 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Val Irvine contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Testing in people with Pulmonary Hypertension, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harrison Stubbs, BMBS (0141 951 5000, harrison.stubbs@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional assessment of novel exercise test validity (part 1) (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.