Inspiratory Muscle Training in Pulmonary Arterial Hypertension
Primary Purpose
Pulmonary Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Inspiratory muscle training device
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension
Eligibility Criteria
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
Sites / Locations
- Golden Jubilee National HospitalRecruiting
Outcomes
Primary Outcome Measures
Six minute walking distance
Secondary Outcome Measures
Quality of life: emPHasis 10 score
emPHasis 10 score
Peak VO2
Assessed by cardiopulmonary exercise test
VE/VCO2 slope
Assessed by cardiopulmonary exercise test
Full Information
NCT ID
NCT04197388
First Posted
December 11, 2019
Last Updated
December 12, 2019
Sponsor
Golden Jubilee National Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04197388
Brief Title
Inspiratory Muscle Training in Pulmonary Arterial Hypertension
Official Title
Inspiratory Muscle Training in Pulmonary Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Golden Jubilee National Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training device
Intervention Description
Inspiratory muscle training, 6 cycles of 30 breaths for 12 weeks.
Primary Outcome Measure Information:
Title
Six minute walking distance
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of life: emPHasis 10 score
Description
emPHasis 10 score
Time Frame
3 months
Title
Peak VO2
Description
Assessed by cardiopulmonary exercise test
Time Frame
3 months
Title
VE/VCO2 slope
Description
Assessed by cardiopulmonary exercise test
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul McCaughey
Phone
07907029041
Email
paulmccaughey@nhs.net
Facility Information:
Facility Name
Golden Jubilee National Hospital
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul McCaughey
Phone
07907029041
Email
paulmccaughey@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Inspiratory Muscle Training in Pulmonary Arterial Hypertension
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