Chronic Thromboembolic Pulmonary HypertensionNCT03102294
Inspiratory Muscle Training in Pulmonary Hypertension
A study testing inspiratory muscle training in people with Chronic Thromboembolic Pulmonary Hypertension and Inspiratory Muscle Training, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Inspiratory muscle training for 8 weeks in patients with pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension, Inspiratory Muscle Training, Inspiratory Muscle Weakness
- What is being tested?
- inspiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2017to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CTEPH confirmed by RHC and imaging
- NYHA FC II-IV
Who cannot join
- Limitation to cycling
- Recent syncope or clinical deterioration
Trial locations and contacts
1 site in 1 country.
Brazil1 site
SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício
São Paulo, São Paul, 04127000
About this study
Official title: Inspiratory Muscle Training in Patients With Pulmonary Hypertension: a Double-blind Randomized Controlled Trial
Inspiratory muscle training for 8 weeks in patients with pulmonary hypertension.
Read the detailed description
32 patients with PH will perform: 1) pulmonary function tests; 2) measurement of maximal inspiratory pressure (MIP) and endurance; 3) six-minute walk test and 5) incremental and constant load cardiopulmonary exercise test (~ 75% of maximal work-rate) and step test. Inspiratory muscle training will consist of twice daily sessions of 30 breaths (~ 50% PiMAX, 4-5 minutes per session) for 8 weeks. The SHAM group will perform sessions of 30 breaths with no inspiratory load.
- Conditions
- Chronic Thromboembolic Pulmonary Hypertension, Inspiratory Muscle Training, Inspiratory Muscle Weakness, Pulmonary Arterial Hypertension
- Being tested
- inspiratory muscle training, Placebo "training"
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingOther
inspiratory muscle training with 50% of MIP
Placebo "training"Other
placebo training with PowerBreathe (without inspiratory load)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: IMT | Active comparator | inspiratory muscle training (PowerBREATHE) with ~50% of maximum inspiratory pressure Receives: Other: inspiratory muscle training |
| Placebo: SHAM | Placebo comparator | inspiratory muscle training (PowerBREATHE) without inspiratory load Receives: Other: Placebo "training" |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity¨- cardiopulmonary exercise testing
TLim (seconds)
Measured: week 8
exercise capacity - 6-min walk test
distance (m)
Measured: week 8
Secondary outcomes (1)
ventilatory responses
VE/VCO2
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 Sep 2017
- Primary completion30 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Roberta Pulcheri Ramos, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102294
- Sponsor's protocol ID
- FUSaoPaulo2017
- Status last verified
- Sep 2025
- First submitted
- 22 Mar 2017
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training in Patients With Pulmonary Hypertension: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03102294
- Acronym / sponsor ID
- FUSaoPaulo2017
- Conditions
- Chronic Thromboembolic Pulmonary Hypertension, Inspiratory Muscle Training, Inspiratory Muscle Weakness, Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 5 Apr 2017 (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.
Inspiratory muscle training for 8 weeks in patients with pulmonary hypertension.
Detailed description
32 patients with PH will perform: 1) pulmonary function tests; 2) measurement of maximal inspiratory pressure (MIP) and endurance; 3) six-minute walk test and 5) incremental and constant load cardiopulmonary exercise test (~ 75% of maximal work-rate) and step test. Inspiratory muscle training will consist of twice daily sessions of 30 breaths (~ 50% PiMAX, 4-5 minutes per session) for 8 weeks. The SHAM group will perform sessions of 30 breaths with no inspiratory load.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: IMT | Active comparator | Other: inspiratory muscle traininginspiratory muscle training (PowerBREATHE) with ~50% of maximum inspiratory pressure |
| Placebo: SHAM | Placebo comparator | Other: Placebo "training"inspiratory muscle training (PowerBREATHE) without inspiratory load |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CTEPH confirmed by RHC and imaging
- NYHA FC II-IV
Key exclusion criteria (2 listed)
- Limitation to cycling
- Recent syncope or clinical deterioration
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 traininginspiratory muscle training with 50% of MIP | Other | Experimental: IMT |
| Placebo "training"placebo training with PowerBreathe (without inspiratory load) | Other | Placebo: SHAM |
Primary outcome
exercise capacity¨- cardiopulmonary exercise testing
Time frame: week 8
TLim (seconds)
exercise capacity - 6-min walk test
Time frame: week 8
distance (m)
1 secondary outcome
ventilatory responses
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Yes
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Early Detection of CTEPH in Patients After APE
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LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Thromboembolic Pulmonary Hypertension and Inspiratory Muscle Training, run by Federal University of São Paulo at 1 site in Brazil.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 18 Sep 2025. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exercise capacity¨- cardiopulmonary exercise testing (time frame: week 8). The study lists 2 primary outcomes in all. 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 18 Sep 2025.