Status:
ENROLLING_BY_INVITATION
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)
Lead Sponsor:
Hospital Universitario Marqués de Valdecilla
Conditions:
Lung Transplantation
Eligibility:
All Genders
18+ years
Phase:
NA
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 resista...
Detailed Description
Background and Current State of Knowledge According to the World Health Organization, chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide, accounting for 3.5 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06963190
Start Date
August 31 2025
End Date
December 1 2027
Last Update
September 8 2025
Active Locations (1)
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1
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008