CClinicalTrials.gg
Status unknownNCT04197388Updated Dec 13, 2019

Inspiratory Muscle Training in Pulmonary Arterial Hypertension

An interventional study of Inspiratory muscle training device in Pulmonary Hypertension, sponsored by Golden Jubilee National Hospital. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-12-13.

Sponsored by Golden Jubilee National Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jun 2019, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 20 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Golden Jubilee National Hospital is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • significant contribution to pulmonary hypertension from lung disease
  • pregnant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • DeviceInspiratory muscle training device

    Inspiratory muscle training, 6 cycles of 30 breaths for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Six minute walking distance

    Time frame: 3 months

Secondary outcomes

  1. Quality of life: emPHasis 10 score

    emPHasis 10 score

    Time frame: 3 months

  2. Peak VO2

    Assessed by cardiopulmonary exercise test

    Time frame: 3 months

  3. VE/VCO2 slope

    Assessed by cardiopulmonary exercise test

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Golden Jubilee National Hospital
    Glasgow, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04197388
Lead sponsor
Golden Jubilee National Hospital
Responsible party
Sponsor
First posted
Dec 13, 2019
Start date
Jun 26, 2019
Primary completion
Apr 1, 2021 (estimated)
Completion
Apr 1, 2021 (estimated)
Last update
Dec 13, 2019

Study contacts

Paul McCaughey
Contact
paulmccaughey@nhs.net
07907029041

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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