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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)

NCT06963190 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

  • Lung Transplantation

Interventions

OTHER

Constant Resistance (CR)

Will perform inspiratory muscle training at 30% of MIP. Two daily sessions of 30 breaths or 10 minutes.

OTHER

Intermittent Variable Resistance (IVR)

Will perform inspiratory muscle training at 30% of MIP. This will consist of two daily sessions of 30 breaths or 10 minutes. Additionally, the participant will complete 8 sets of 3 repetitions at 60% of the MIP, distributed throughout the day, with a one-minute rest between each repetition.

Sponsors & Collaborators

  • Hospital Universitario Marqués de Valdecilla

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06963190 on ClinicalTrials.gov