Home-based Inspiratory Muscle Training in Pulmonary Hypertension
NCT07917416, Not applicable, Not yet recruiting, Universidad Complutense de Madrid
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Home-based Inspiratory Muscle Training in Pulmonary Hypertension | ClinicalTrials.gov |
| NCT number | NCT07917416 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universidad Complutense de Madrid | ClinicalTrials.gov |
| Conditions | Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension | ClinicalTrials.gov |
| Interventions | Inspiratory muscle training, Sham inspiratory muscle training | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Ventilatory efficiency (VE/VCO2 slope) | 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. | ClinicalTrials.gov |
| Secondary | Airway inflammation | Baseline (pre-intervention) and at 8 weeks (post-intervention) | Fractional exhaled nitric oxide (FeNO) in ppb measured following ATS/ERS guidelines; mean of two reproducible values. | ClinicalTrials.gov |
| Secondary | Inspiratory muscle strength | Baseline (pre-intervention) and at 8 weeks (post-intervention) | Maximal inspiratory pressure from residual volume following ERS statement. | ClinicalTrials.gov |
| Secondary | Dyspnoea (Dyspnoea-12) | Baseline (pre-intervention) and at 8 weeks (post-intervention) | Spanish version of Dyspnoea-12: 12 items (6 physical, 6 affective) scored 0-3; total 0-36. Higher scores indicates greater dyspnea severity. | ClinicalTrials.gov |
| Secondary | Health-related quality of life (Cambridge Pulmonary Hypertension Outcome Review [CAMPHOR]) | Baseline (pre-intervention) and at 8 weeks (post-intervention) | 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. | ClinicalTrials.gov |
| Secondary | Forced vital capacity (FVC) | Baseline (pre-intervention) and at 8 weeks (post-intervention) | The total volume of air that can be forcibly exhaled after a maximal inspiration. Will be assessed by forced spirometry following ATS/ERS guidelines | ClinicalTrials.gov |
| Secondary | Forced expiratory volume in 1 second (FEV₁) | Baseline (pre-intervention) and at 8 weeks (post-intervention) | 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. | ClinicalTrials.gov |
| Secondary | FEV₁/FVC ratio | Baseline (pre-intervention) and at 8 weeks (post-intervention) | 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. | ClinicalTrials.gov |
| Secondary | Peak expiratory flow (PEF) | Baseline (pre-intervention) and at 8 weeks (post-intervention) | 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. | ClinicalTrials.gov |
| Other | Blinding success | At 8 weeks | Participants' guess of their allocation, summarized with a blinding index. | ClinicalTrials.gov |
| Other | Adherence to the telerehabilitation programme | Throughout the 8-week intervention | Percentage of prescribed training sessions completed, based on training diaries and video-call records. | ClinicalTrials.gov |
| Other | Adverse events | Throughout the 8-week intervention | Number and type of adverse events during the intervention, recorded systematically through training diaries and video calls. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)