Remote Exercise Testing in Patients With Pulmonary Hypertension

NCT ID: NCT05299463

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Exercise study

Study Groups

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Exercise

Group Type OTHER

Exercise Testing

Intervention Type DIAGNOSTIC_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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Scottish Pulmonary Vascular Unit

Glasgow, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Harrison Stubbs, BMBS

Role: CONTACT

0141 951 5000

Val Irvine

Role: CONTACT

0141 951 5000

Facility Contacts

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Val Irvine

Role: primary

0141 951 5000

Other Identifiers

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293065

Identifier Type: -

Identifier Source: org_study_id

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