Inspiratory Muscle Training in Pulmonary Arterial Hypertension
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2019
CompletedFirst Submitted
Initial submission to the registry
December 11, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedDecember 13, 2019
December 1, 2019
1.8 years
December 11, 2019
December 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Six minute walking distance
3 months
Secondary Outcomes (3)
Quality of life: emPHasis 10 score
3 months
Peak VO2
3 months
VE/VCO2 slope
3 months
Interventions
Inspiratory muscle training, 6 cycles of 30 breaths for 12 weeks.
Eligibility Criteria
You may qualify if:
- diagnosed by pulmonary hypertension specialist with precapillary pulmonary hypertension
- able to give consent
- stable on medical therapy for at least 3 months
You may not qualify if:
- significant contribution to pulmonary hypertension from lung disease
- pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Golden Jubilee National Hospital
Glasgow, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2019
First Posted
December 13, 2019
Study Start
June 26, 2019
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
December 13, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share