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 | Enrolling By Invitation

• 1 other identifier: Impact of IMT en LTX patients
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Respiratory Muscle Training; Lung Transplantation; Respiratory Function Tests; Spirometry; Blood Gas Analysis; Walk Test; Diaphragm Paralysis

Outcome Measures

Primary Outcomes (2)

• Dependent variables

  Maximal inspiratory pressure: Expressed in cmH₂O.

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

• Dependent variables

  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.

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

Secondary Outcomes (2)

• Demographic and Transplant-Related Variables

  Measurements will be performed at the time of recruitment (baseline)

• Demographic and Transplant-Related Variables

  Measurements will be performed at the time of recruitment (baseline)

Study Arms (2)

Constant Resistance (CR)

ACTIVE COMPARATOR

Other: Constant Resistance (CR)

Intermittent Variable Resistance (IVR)

EXPERIMENTAL

Other: Intermittent Variable Resistance (IVR)

Interventions

Constant Resistance (CR) OTHER

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

Constant Resistance (CR)

Intermittent Variable Resistance (IVR) OTHER

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.

Intermittent Variable Resistance (IVR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Marqués de Valdecilla: lead

Study Sites (1)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

MeSH Terms

Conditions

Respiratory Paralysis

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: May 8, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)