Pulmonary Arterial HypertensionSLOPE-PHNCT07917416
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
A study testing Inspiratory muscle training in people with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Medical diagnosis of pulmonary hypertension group 1 (pulmonary arterial hypertension) or group 4 (chronic thromboembolic pulmonary hypertension) according to the 2022 ESC/ERS guidelines.
- Transthoracic echocardiography performed within the previous 6 months.
- Clinical stability: no hospitalizations, changes in PH-specific treatment or worsening of functional class in the previous 3 months.
- Sufficient functional capacity to perform cardiopulmonary exercise testing and the other study assessments.
- Signed informed consent.
Who cannot join
- Absolute contraindications to cardiopulmonary exercise testing according to current guidelines.
- Neuromuscular disease or conditions with primary diaphragmatic involvement.
- Thoracic or abdominal surgery in the previous 3 months.
- Severe comorbidities unrelated to PH pathophysiology (e.g., severe COPD or unstable ischaemic heart disease).
- Current participation in cardiopulmonary rehabilitation, or participation in the previous 3 months.
- Pregnancy or breastfeeding.
- Inability to understand or follow the telerehabilitation programme.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universidad Complutense de Madrid
Madrid, Madrid, 28040
Raúl Fabero-Garrido, MSc, +34 91 394 1524, rfabero@ucm.es
About this study
Official title: Efficacy of Inspiratory Muscle Training Delivered Through Telerehabilitation on Ventilatory Efficiency in People With Pulmonary Hypertension: a Double-blind, Placebo-controlled Randomized Clinical Trial
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.
- Being tested
- Inspiratory muscle training, Sham inspiratory muscle training
- Keywords
- Pulmonary Hypertension, Inspiratory Muscle Training, Ventilatory Efficiency, Telerehabilitation
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Also called IMT
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.
Sham inspiratory muscle trainingOther
Also called Sham 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.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training (IMT) | Experimental | Home-based IMT through telerehabilitation for 8 weeks with progressive loads from 30% to 60% of MIP. Receives: Other: Inspiratory muscle training |
| Sham inspiratory muscle training | Sham comparator | Identical telerehabilitation programme for 8 weeks using a device without effective inspiratory resistance. Receives: Other: Sham inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Secondary outcomes (8)
Airway inflammation
Fractional exhaled nitric oxide (FeNO) in ppb measured following ATS/ERS guidelines; mean of two reproducible values.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Inspiratory muscle strength
Maximal inspiratory pressure from residual volume following ERS statement.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group, placebo-controlled randomized clinical trial with 1:1 allocation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital Clínico San Carlos
- Responsible party
- Principal investigator, Ibai López de Uralde Villanueva, Universidad Complutense de Madrid
- Investigators
- Raúl Fabero-Garrido, MSc, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917416
- Sponsor's protocol ID
- VIIAIFE202611
- Other IDs
- VIIAIFE202611
- Acronym
- SLOPE-PH
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To maintain privacy policies
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Inspiratory Muscle Training Delivered Through Telerehabilitation on Ventilatory Efficiency in People With Pulmonary Hypertension: a Double-blind, Placebo-controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07917416
- Acronym / sponsor ID
- SLOPE-PH / VIIAIFE202611
- Keywords
- Pulmonary Hypertension, Inspiratory Muscle Training, Ventilatory Efficiency, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital Clínico San Carlos
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, placebo-controlled randomized clinical trial with 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training (IMT) | Experimental | Other: Inspiratory muscle trainingHome-based IMT through telerehabilitation for 8 weeks with progressive loads from 30% to 60% of MIP. |
| Sham inspiratory muscle training | Sham comparator | Other: Sham inspiratory muscle trainingIdentical telerehabilitation programme for 8 weeks using a device without effective inspiratory resistance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Medical diagnosis of pulmonary hypertension group 1 (pulmonary arterial hypertension) or group 4 (chronic thromboembolic pulmonary hypertension) according to the 2022 ESC/ERS guidelines.
- Transthoracic echocardiography performed within the previous 6 months.
- Clinical stability: no hospitalizations, changes in PH-specific treatment or worsening of functional class in the previous 3 months.
- Sufficient functional capacity to perform cardiopulmonary exercise testing and the other study assessments.
Key exclusion criteria (7 listed)
- Absolute contraindications to cardiopulmonary exercise testing according to current guidelines.
- Neuromuscular disease or conditions with primary diaphragmatic involvement.
- Thoracic or abdominal surgery in the previous 3 months.
- Severe comorbidities unrelated to PH pathophysiology (e.g., severe COPD or unstable ischaemic heart disease).
- Current participation in cardiopulmonary rehabilitation, or participation in the previous 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingAlso: IMTIt 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. | Other | Inspiratory muscle training (IMT) |
| Sham inspiratory muscle trainingAlso: Sham IMTIdentical-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. | Other | Sham inspiratory muscle training |
Primary outcome
Ventilatory efficiency (VE/VCO2 slope)
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Slope of the relationship between minute ventilation and carbon dioxide output, obtained during an individualized, continuous incremental cardiopulmonary exercise test, following international standards.
8 secondary outcomes
Airway inflammation
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Inspiratory muscle strength
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Dyspnoea (Dyspnoea-12)
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Health-related quality of life (Cambridge Pulmonary Hypertension Outcome Review [CAMPHOR])
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Forced vital capacity (FVC)
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Forced expiratory volume in 1 second (FEV₁)
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
FEV₁/FVC ratio
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Peak expiratory flow (PEF)
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. To maintain privacy policies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raúl Fabero-Garrido, MSc principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raúl Fabero-Garrido, MSc (+34 91 394 1524, rfabero@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory efficiency (VE/VCO2 slope) (time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.