Inspiratory Muscle Training in Pulmonary Arterial Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Inspiratory Muscle Training in Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04197388
• Other study ID #: 18/CARD/31
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: December 2019
• Source: Golden Jubilee National Hospital
• Contact: Paul McCaughey
• Phone: 07907029041
• Email: paulmccaughey[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Device:
• Inspiratory muscle training device
Inspiratory muscle training, 6 cycles of 30 breaths for 12 weeks.

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Golden Jubilee National Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six minute walking distance		3 months
Secondary	Quality of life: emPHasis 10 score	emPHasis 10 score	3 months
Secondary	Peak VO2	Assessed by cardiopulmonary exercise test	3 months
Secondary	VE/VCO2 slope	Assessed by cardiopulmonary exercise test	3 months