Pulmonary HypertensionPERSPIRENCT04903704
Pulmonary Hypertension and Measurement of Exercise Capacity Remotely
A study testing 1 Minute Sit to Stand Test in people with Pulmonary Hypertension, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Background Hospital-based walking exercise tests are routinely used in patients with pulmonary hypertension to assess functional ability and disease progression over time. We are seeing a greater emphasis on non-face-to-face clinical assessments, where such tests cannot be conducted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- 1 Minute Sit to Stand Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jun 2021to 15 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH)
Who cannot join
- mobility significantly impaired by musculoskeletal or neurological co-morbidities; learning difficulties or cognitive impairment that would prohibit informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
About this study
Official title: Pulmonary HypERtenSion and Measurement of Exercise caPacIty REmotely: the PERSPIRE Study
Background
Hospital-based walking exercise tests are routinely used in patients with pulmonary hypertension to assess functional ability and disease progression over time. We are seeing a greater emphasis on non-face-to-face clinical assessments, where such tests cannot be conducted. It is important to identify alternative tests which can be which can be conducted by patients at home and used to support clinical decision making.
Read more
Aim
To test the safety of the 1-minute sit-to-stand test in patients with pulmonary hypertension and its comparability with hospital-based walking exercise tests.
Methods
A sample of 75 patients attending hospital appointments will carry out an Incremental Shuttle Walk Test, followed by a 1-minute sit-to-stand test after a 30 minute rest. Data will be analysed for safety and comparability between the 2 tests.
In the event of favourable findings (safety and comparability) from the hospital-based testing, a further sample of patients will be asked to perform the 1-minute sit-to-stand test in the home setting
Read the detailed description
Pulmonary hypertension (PH) is a progressive condition affecting the circulation to the lungs from the heart. It is a rare condition and Sheffield Pulmonary Vascular Diseases Unit (SPVDU) is the largest of 7 adult specialist pulmonary hypertension centres, caring for 1900 patients, or 30% of the pulmonary hypertension patients treated in the UK. Measures of how well patients tolerate exercise and their functional abilities are widely established in pulmonary hypertension. This includes hospital-based assessments such as Incremental Shuttle Walk Test (ISWT - a "beep" test which requires patients to walk progressively faster until they cannot continue) and 6 minute walking test (how far patients can walk in 6 minutes), which are included in international risk guidelines for PH. At SPVDU patients attend clinic appointments at intervals ranging from 3 -12 months; an ISWT is conducted at every clinic visit and the results are used to monitor functional progress over time.
This study will seek to establish the safety of the 1-minute sit-to-stand test and its comparability to the Incremental Shuttle Walk Test. Participants will be recruited as part of their standard clinic visit to SPVDU. They will undergo their standard clinical Incremental Shuttle Walk Test. This test is a standard of clinical care and its essential to the patient assessment on their clinical visit and will therefore be conducted first in all cases. They will be allowed a 30 minute rest before undertaking the 1-minute sit-to-stand test.
It is standard at SPVDU that patients undertake the Incremental Shuttle Walk Test without supplemental oxygen - standardised protocols allow for this if repeat tests follow the same procedure. Patients are advised that they should stop the activity when they feel they can no longer continue. The same protocol will be adopted for the 1-minute sit-to-stand test.
Clinical observations (heart rate, blood pressure, oxygen saturations) will be taken before and after both tests. Heart rate and oxygen saturations will be monitored during both tests. Patient reported measures of breathlessness and perceived exertion will be recorded on completion of both tests.
Adverse events e.g. dizziness, syncope or the participant becoming unwell be recorded. Adverse event data will be monitored and analysed to determine the safety of the 1MSTS test. To assist in the planning or potential next stages of the study, participants will be asked if they have access to equipment that would support home monitoring e.g. tape measure, BP monitor, pulse oximeter, weighing scales, video calling.
Data collected during the testing will be analysed, along with other routinely collected clinical data to determine the comparability of the 1MSTS test with with ISWT and other clinical features.
- Conditions
- Pulmonary Hypertension
- Being tested
- 1 Minute Sit to Stand Test
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Minute Sit to Stand TestDiagnostic test
Participants are asked to stand repeatedly from a chair for one minute without the use of their arms for support. The number of completed repetitions is counted.
| Study group | Role | What they receive |
|---|---|---|
| Sit to Stand testing | Other | Participants will undergo an ISWT in the hospital setting. This test is a standard of clinical care and it is essential to the patient assessment on their clinical visit. This test will therefore be conducted first in all cases.
They will be allowed a 30 minute rest before undertaking the 1MSTS test.
Clinical observations (heart rate, blood pressure, oxygen saturations) will be taken before and after both tests. Heart rate and oxygen saturations will be monitored during both tests.
Patient reported measures of dyspnoea and perceived exertion will be recorded on completion of both tests.
Adverse events e.g. dizziness, syncope or the participant becoming unwell be recorded.
Descriptive and inferential statistical analysis will be used to determine the safety of 1MSTS in the hospital setting and comparability between 1MSTS and ISWT for participants. We will also examine comparability between 1MSTS outcomes and other available routinely collected clinical data. Receives: Diagnostic Test: 1 Minute Sit to Stand Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit to stand repititions
The number of completed sit to stand repetitions in 1 minute
Measured: Counted during testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start8 Jun 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Carol Keen, Principal investigator, Physiotherapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903704
- Sponsor's protocol ID
- STH21477
- Acronym
- PERSPIRE
- Status last verified
- Sep 2021
- First submitted
- 21 May 2021
- Last updated
- 17 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary HypERtenSion and Measurement of Exercise caPacIty REmotely: the PERSPIRE Study
- ClinicalTrials.gov ID
- NCT04903704
- Acronym / sponsor ID
- PERSPIRE / STH21477
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Manchester Metropolitan University
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 26 May 2021 (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.
Background
Hospital-based walking exercise tests are routinely used in patients with pulmonary hypertension to assess functional ability and disease progression over time. We are seeing a greater emphasis on non-face-to-face clinical assessments, where such tests cannot be conducted. It is important to identify alternative tests which can be which can be conducted by patients at home and used to support clinical decision making.
Aim
To test the safety of the 1-minute sit-to-stand test in patients with pulmonary hypertension and its comparability with hospital-based walking exercise tests.
Methods
A sample of 75 patients attending hospital appointments will carry out an Incremental Shuttle Walk Test, followed by a 1-minute sit-to-stand test after a 30 minute rest. Data will be analysed for safety and comparability between the 2 tests.
In the event of favourable findings (safety and comparability) from the hospital-based testing, a further sample of patients will be asked to perform the 1-minute sit-to-stand test in the home setting
Detailed description
Pulmonary hypertension (PH) is a progressive condition affecting the circulation to the lungs from the heart. It is a rare condition and Sheffield Pulmonary Vascular Diseases Unit (SPVDU) is the largest of 7 adult specialist pulmonary hypertension centres, caring for 1900 patients, or 30% of the pulmonary hypertension patients treated in the UK. Measures of how well patients tolerate exercise and their functional abilities are widely established in pulmonary hypertension. This includes hospital-based assessments such as Incremental Shuttle Walk Test (ISWT - a "beep" test which requires patients to walk progressively faster until they cannot continue) and 6 minute walking test (how far patients can walk in 6 minutes), which are included in international risk guidelines for PH. At SPVDU patients attend clinic appointments at intervals ranging from 3 -12 months; an ISWT is conducted at every clinic visit and the results are used to monitor functional progress over time.
This study will seek to establish the safety of the 1-minute sit-to-stand test and its comparability to the Incremental Shuttle Walk Test. Participants will be recruited as part of their standard clinic visit to SPVDU. They will undergo their standard clinical Incremental Shuttle Walk Test. This test is a standard of clinical care and its essential to the patient assessment on their clinical visit and will therefore be conducted first in all cases. They will be allowed a 30 minute rest before undertaking the 1-minute sit-to-stand test.
It is standard at SPVDU that patients undertake the Incremental Shuttle Walk Test without supplemental oxygen - standardised protocols allow for this if repeat tests follow the same procedure. Patients are advised that they should stop the activity when they feel they can no longer continue. The same protocol will be adopted for the 1-minute sit-to-stand test.
Clinical observations (heart rate, blood pressure, oxygen saturations) will be taken before and after both tests. Heart rate and oxygen saturations will be monitored during both tests. Patient reported measures of breathlessness and perceived exertion will be recorded on completion of both tests.
Adverse events e.g. dizziness, syncope or the participant becoming unwell be recorded. Adverse event data will be monitored and analysed to determine the safety of the 1MSTS test. To assist in the planning or potential next stages of the study, participants will be asked if they have access to equipment that would support home monitoring e.g. tape measure, BP monitor, pulse oximeter, weighing scales, video calling.
Data collected during the testing will be analysed, along with other routinely collected clinical data to determine the comparability of the 1MSTS test with with ISWT and other clinical features.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sit to Stand testing | Other | Diagnostic Test: 1 Minute Sit to Stand TestParticipants will undergo an ISWT in the hospital setting. This test is a standard of clinical care and it is essential to the patient assessment on their clinical visit. This test will therefore be conducted first in all cases. They will be allowed a 30 minute rest before undertaking the 1MSTS test. Clinical observations (heart rate, blood pressure, oxygen saturations) will be taken before and after both tests. Heart rate and oxygen saturations will be monitored during both tests. Patient reported measures of dyspnoea and perceived exertion will be recorded on completion of both tests. Adverse events e.g. dizziness, syncope or the participant becoming unwell be recorded. Descriptive and inferential statistical analysis will be used to determine the safety of 1MSTS in the hospital setting and comparability between 1MSTS and ISWT for participants. We will also examine comparability between 1MSTS outcomes and other available routinely collected clinical data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH)
Key exclusion criteria (1 listed)
- mobility significantly impaired by musculoskeletal or neurological co-morbidities; learning difficulties or cognitive impairment that would prohibit informed consent
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 |
|---|---|---|
| 1 Minute Sit to Stand TestParticipants are asked to stand repeatedly from a chair for one minute without the use of their arms for support. The number of completed repetitions is counted. | Diagnostic test | Sit to Stand testing |
Primary outcome
Sit to stand repititions
Time frame: Counted during testing
The number of completed sit to stand repetitions in 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
Carol Keen principal investigator
Physiotherapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 Minute Sit to Stand Test in people with Pulmonary Hypertension, run by Sheffield Teaching Hospitals NHS Foundation Trust 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit to stand repititions (time frame: Counted during testing). 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 17 Mar 2022.