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)

Launched by HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA · Apr 29, 2025

Keywords

ClinConnect Summary

The I-TRAIN-LTx Study is a clinical trial that aims to understand how different types of inspiratory muscle training (IMT) can help patients who have received a lung transplant. Specifically, the study compares two methods: one that uses constant resistance (CR) and another that uses intermittent variable resistance (IVR). The main goal is to see which method helps improve a measure called Maximum Inspiratory Pressure (MIP), which indicates how well a patient can breathe in. Additionally, the trial will look at other important factors like walking ability, lung function tests, and blood gas analysis during the first six months after the transplant.

To participate in this study, you must be an adult who has had a single or double lung transplant and is stable enough to join. Key requirements include being alert and able to cooperate, having controlled blood pressure and heart rate, and not experiencing severe breathing difficulties at rest. During the study, participants will be randomly assigned to one of the two training groups. They can expect to receive guidance on their breathing exercises and regular assessments to track their progress. This research may help improve recovery strategies for future lung transplant patients.

Gender

ALL

Eligibility criteria

• 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.