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)

Condition(s) studied

Investigational drug(s) / intervention(s)

Constant Resistance (CR): Will perform inspiratory muscle training at 30% of MIP. Two daily sessions of 30 breaths or 10 minutes.

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.

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.

Eligibility

Primary outcome measure(s)

• Dependent variables — Measurements will be performed at the time of recruitment (baseline) and at months 1, 2, 4, and 6 post-transplant.
  Maximal inspiratory pressure: Expressed in cmH₂O.
• Dependent variables — Measurements will be performed at the time of recruitment (baseline) and at months 1, 2, 4, and 6 post-transplant.
  Spirometry: Forced expiratory volume in the first second (FEV1) in mL and percentage of predicted, forced vital capacity (FVC) in mL and percentage, and FEV1/FVC ratio.

Trial sites (1)

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