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Status unknownNCT05299463Updated Mar 29, 2022

Remote Exercise Testing in Patients With Pulmonary Hypertension

An interventional study of Exercise Testing in Pulmonary Hypertension, sponsored by Golden Jubilee National Hospital. Status unknown at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-03-29.

Sponsored by Golden Jubilee National Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Hypertension
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 100 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Golden Jubilee National Hospital is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 16-years-old and above
  • Diagnosed with pulmonary hypertension from any ERS/ESC group
  • Able to give informed consent

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Exercise

    Diagnostic Test: Exercise Testing

Interventions

  • Diagnostic testExercise 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).

06

What researchers measure

Primary outcomes

  1. 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). 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.

    Time frame: 2 years

  2. 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.

    Time frame: 2 years

  3. 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).

    Time frame: 2 years

  4. 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.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Scottish Pulmonary Vascular Unit
    Glasgow, G413AU, United Kingdom
    • Val Irvine · Contact · 0141 951 5000
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05299463
Lead sponsor
Golden Jubilee National Hospital
Responsible party
Sponsor
First posted
Mar 29, 2022
Start date
Jun 9, 2021
Primary completion
Aug 1, 2023 (estimated)
Completion
Aug 1, 2024 (estimated)
Last update
Mar 29, 2022

Study contacts

Harrison Stubbs, BMBS
Contact
harrison.stubbs@ggc.scot.nhs.uk
0141 951 5000
Val Irvine
Contact
0141 951 5000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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