By InvitationNot Applicable

Impact of Inspiratory Muscle Training (IMT) With Intermittent Variable Resistance (IVR) Versus Constant Resistance (CR) on Functional Capacity in Lung Transplantation (LTx) Patients (I-TRAIN-LTx Study)

Spain42 participantsStarted 2025-08-31

Plain-language summary

\- Objectives: Primary Objective: To compare Maximum Inspiratory Pressure (MIP) in lung transplant (LT) patients between the use of inspiratory muscle training (IMT) with intermittent variable resistance (IVR) or constant resistance (CR) during the first six months post-transplant. Secondary Objectives: To determine whether there are differences in the outcomes of IMT with IVR and IMT with CR in the six-minute walk test, spirometry values, and arterial blood gas analysis within the first six months post-transplant. To analyze the influence of relevant clinical conditions on dependent variables in both groups: duration of mechanical ventilation during the immediate postoperative period of LT and presence of diaphragmatic paralysis. To analyze the proportion of patients with Baseline Lung Allograft Dysfunction (BLAD) in both intervention groups. \- Methodology: Design: Open-label, two-arm, randomized clinical trial. Intervention: Random allocation into: CR Group: Will perform IMT at 30% of MIP. IVR Group: Will perform IMT at 30% and 60% of MIP. Population and Sample: Patients undergoing lung transplantation. Demographic and LT-related variables: Sex, date of birth, height, weight, body mass index, type of transplant, underlying disease leading to transplantation, phrenic paralysis, length of stay in the intensive care unit, days on mechanical ventilation, primary graft dysfunction, and acute rejection. Dependent Variables: MIP, spirometry, arterial blood gas analysis, six-minute walk test, and BLAD criteria.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patient (≥18 years) who has undergone lung transplantation (single-lung or double-lung) at our center. * Alert and cooperative (Glasgow Coma Scale \>13 points). * Hemodynamically stable (blood pressure between 90/60 and 165/90 mmHg; heart rate between 60 and 130 beats per minute). * No disabling dyspnea at rest (maintained at mild levels according to the Borg scale or NYHA class I-II), even if requiring supplemental oxygen with a saturation \>89%. * No limiting chest pain interfering with respiratory therapy. Exclusion Criteria: * Patients unable to cooperate with treatment due to lack of necessary instrumental cognitive skills. * Perceived non-adherence to pharmacological and non-pharmacological treatment by healthcare personnel. * Need for continuous non-invasive mechanical ventilation, high-flow oxygen therapy, or Venturi mask. * Patients with significant neurological disorders, severe polyneuropathies, or stroke (CVA). * Presence of tracheostomy, active hemoptysis, bronchial suture dehiscence. * Significant air leak with clinical repercussions. * Any clinical condition that, in the investigator's judgment, poses a risk to the patient.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dependent variables

Timeframe: Measurements will be performed at the time of recruitment (baseline) and at months 1, 2, 4, and 6 post-transplant.

Dependent variables

Timeframe: Measurements will be performed at the time of recruitment (baseline) and at months 1, 2, 4, and 6 post-transplant.

Trial details

NCT IDNCT06963190

SponsorHospital Universitario Marqués de Valdecilla

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

View on ClinicalTrials.gov More Lung Transplantation trials