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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
Golden Jubilee National Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 11, 2019
Last Updated
December 12, 2019
Sponsor
Golden Jubilee National Hospital
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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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