An interventional study of Inspiratory muscle training and Sham inspiratory muscle training in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension, sponsored by Universidad Complutense de Madrid. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
The main objective of this study is to determine whether an 8-week inspiratory muscle training (IMT) programme, delivered at home through telerehabilitation, improves ventilatory efficiency (VE/VCO2 slope) compared with a sham (placebo) training programme in adults with pulmonary hypertension. Secondary objectives are to analyse its effects on airway inflammation, inspiratory muscle strength, lung function, ventilatory pattern and mechanical efficiency during exercise, dyspnoea and health-related quality of life.
Forty participants will be randomly allocated (1:1) to active IMT or sham IMT. Both groups will train twice a day, 5 days a week, for 8 weeks, with biweekly load adjustments and supervision through video calls. Participants, therapists, outcome assessors and the statistician will be blinded to group allocation.
774 studies on the registry are indexed under Pulmonary Arterial Hypertension; 143 are open to participants now.
This study's planned enrollment of 40 is close to the median of 38 across 518 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
Home-based IMT through telerehabilitation for 8 weeks with progressive loads from 30% to 60% of MIP.
Other: Inspiratory muscle training
Identical telerehabilitation programme for 8 weeks using a device without effective inspiratory resistance.
Other: Sham inspiratory muscle training
It will be employed a POWERbreathe device (HaB International Ltd., UK) with adjustable inspiratory resistance and unloaded expiration. Load starts at 30% of MIP and increases by 10% every two weeks up to 60%. 4 sets of 15 breaths, twice a day, 5 days a week, for 8 weeks. Supervision through 3 video calls per week and a training diary reviewed weekly.
Also known as: IMT
Identical-looking POWERbreathe device without the valve, so inspiratory resistance is nil at any dial setting. Participants adjust the dial weekly following the same progression schedule, with the same dose (4 sets of 15 breaths, twice a day, 5 days a week, 8 weeks) and supervision as the IMT group.
Also known as: Sham IMT
Ventilatory efficiency (VE/VCO2 slope)
Slope of the relationship between minute ventilation and carbon dioxide output, obtained during an individualized, continuous incremental cardiopulmonary exercise test, following international standards.
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Airway inflammation
Fractional exhaled nitric oxide (FeNO) in ppb measured following ATS/ERS guidelines; mean of two reproducible values.
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Inspiratory muscle strength
Maximal inspiratory pressure from residual volume following ERS statement.
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Dyspnoea (Dyspnoea-12)
Spanish version of Dyspnoea-12: 12 items (6 physical, 6 affective) scored 0-3; total 0-36. Higher scores indicates greater dyspnea severity.
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Health-related quality of life (Cambridge Pulmonary Hypertension Outcome Review [CAMPHOR])
Quality-of-life scale of the Spanish Cambridge Pulmonary Hypertension Outcome Review: 25 true/false items, total 0-25. Higher scores indicates lower health-related quality of life.
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Forced vital capacity (FVC)
The total volume of air that can be forcibly exhaled after a maximal inspiration. Will be assessed by forced spirometry following ATS/ERS guidelines
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Forced expiratory volume in 1 second (FEV₁)
The volume of air forcibly exhaled during the first second of the forced expiratory maneuver. Will be assessed by forced spirometry following ATS/ERS guidelines.
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
FEV₁/FVC ratio
The proportion of the FVC exhaled during the first second of the forced expiratory maneuver. Will be assessed by forced spirometry following ATS/ERS guidelines.
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Peak expiratory flow (PEF)
The maximum flow rate achieved during forced expiration after maximal inspiration, reflecting the highest instantaneous expiratory airflow. Will be assessed by forced spirometry following ATS/ERS guidelines.
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Blinding success
Participants' guess of their allocation, summarized with a blinding index.
Time frame: At 8 weeks
Adherence to the telerehabilitation programme
Percentage of prescribed training sessions completed, based on training diaries and video-call records.
Time frame: Throughout the 8-week intervention
Adverse events
Number and type of adverse events during the intervention, recorded systematically through training diaries and video calls.
Time frame: Throughout the 8-week intervention
Plan to share: No — To maintain privacy policies
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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