Inspiratory Muscle Training in Pulmonary Hypertension | NCT03102294

Studies
Inspiratory Muscle Training in Pulmonary Hypertension

NCT03102294

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Sep 18, 2025Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Chronic Thromboembolic Pulmonary Hypertension
Inspiratory Muscle Training
Inspiratory Muscle Weakness
Pulmonary Arterial Hypertension

Interventions

inspiratory muscle training
Placebo "training"

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Dec 30, 2024Actual

Completion Date

Jan 30, 2025Actual

First Submitted Date

Mar 22, 2017

First Submission Date that Met QC Criteria

Mar 30, 2017

First Posted Date

Apr 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2025

Last Update Posted Date

Sep 18, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Roberta Pulcheri Ramos, Professor, Federal University of São PauloPrincipal Investigator

Lead Sponsor

Federal University of São PauloOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental: IMT	Active Comparator	inspiratory muscle training (PowerBREATHE) with ~50% of maximum inspiratory pressure	Other: inspiratory muscle training
Placebo: SHAM	Placebo Comparator	inspiratory muscle training (PowerBREATHE) without inspiratory load	Other: Placebo "training"

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inspiratory muscle training	Other	inspiratory muscle training with 50% of MIP	Experimental: IMT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
exercise capacity¨- cardiopulmonary exercise testing	TLim (seconds)	week 8
exercise capacity - 6-min walk test	distance (m)	week 8

Secondary Outcomes

Measure	Description	Time Frame
ventilatory responses	VE/VCO2	Week 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CTEPH confirmed by RHC and imaging
NYHA FC II-IV

Exclusion Criteria:

Limitation to cycling
Recent syncope or clinical deterioration

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício		São Paulo	São Paul	04127000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000081029	Pulmonary Arterial Hypertension

Ancestor Terms

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided