- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04197388
Inspiratory Muscle Training in Pulmonary Arterial Hypertension
Pulmonary arterial hypertension is a rare condition characterised by high blood pressure in the lungs and results in breathlessness and reduced exercise capacity for patients. Previous research has shown weakness in respiratory muscles in these patients that may contribute towards their symptoms. Despite advances in medical therapy, the condition still results in a significant symptom burden.
Inspiratory muscle training is a non-invasive intervention involving a device that provides resistance to the muscles of inspiration and increases their strength.
This study will investigate the benefit of inspiratory muscle training in patients with pulmonary arterial hypertension who are stable on medical therapy for three months. This will be performed as an outpatient and they will then be reviewed following this with assessment of exercise capacity, breathing capacity (spirometry), quality of life, and assessment of neural respiratory drive (the signals from the brain to the muscles controlling breathing).
The study will be based at the Golden Jubilee National Hospital and patients will be recruited from outpatients who are already under the care of the Scottish Pulmonary Vascular Unit.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul McCaughey
- Phone Number: 07907029041
- Email: paulmccaughey@nhs.net
Study Locations
-
-
-
Glasgow, United Kingdom
- Recruiting
- Golden Jubilee National Hospital
-
Contact:
- Paul McCaughey
- Phone Number: 07907029041
- Email: paulmccaughey@nhs.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosed by pulmonary hypertension specialist with precapillary pulmonary hypertension
- able to give consent
- stable on medical therapy for at least 3 months
Exclusion Criteria:
- significant contribution to pulmonary hypertension from lung disease
- pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Six minute walking distance
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life: emPHasis 10 score
Time Frame: 3 months
|
emPHasis 10 score
|
3 months
|
Peak VO2
Time Frame: 3 months
|
Assessed by cardiopulmonary exercise test
|
3 months
|
VE/VCO2 slope
Time Frame: 3 months
|
Assessed by cardiopulmonary exercise test
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18/CARD/31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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