Efficacy of Early Inspiratory Muscle Training Combined With the Conventional Rehabilitation Programme in Lung Transplanted Patients

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Lung transplantation is an effective therapeutic option in the end-stage of chronic respiratory diseases. Lung transplantation improves lung function in terms of capacity and volume. However, the transplanted patient still suffers from muscle weakness and exercise intolerance. In recent years, respiratory physiotherapy work has intensified in critically ill patients with respiratory muscle weakness and the application of inspiratory muscle training (IMT), which has been shown in several studies to increase inspiratory muscle strength (IMT), improve ventilation and reduce the sensation of shortness of breath. Despite this emerging evidence, inspiratory muscle training (IMT) is not standard practice in most ICUs around the world, nor is it included in a protocolised manner among the components of a pulmonary rehabilitation programme. Given the limited evidence, the investigators propose to conduct this randomised controlled clinical trial in lung transplant recipients. The study will compare two groups of transplanted patients, a control group that will follow the rehabilitation programme and standard medical care and another experimental group that will also perform inspiratory muscle training. This study aims to analyse the effect of IMT on inspiratory muscle strength, exercise capacity and quality of life in lung transplant patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Alert or able to cooperate with treatment.

• Able to give Informed Consent and sign it.

• Haemodynamically stable clinical situation or requiring minimal ventilatory support.

Locations
Other Locations
Spain
Laura Muelas Gómez
RECRUITING
Majadahonda
Contact Information
Primary
Laura Muelas Gómez, PT, MSc
laura.muelas@salud.madrid.org
+0034 656605303
Backup
Montserrat Solis Muñoz, PhD
montserrat.solis@salud.madrid.org
+0034 911917457
Time Frame
Start Date: 2022-02-04
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 54
Treatments
No_intervention: Control group: Conventional Rehabilitation Program
Standard rehabilitation program for 3 months, starting in the early phase in the ICU. A daily session from monday to friday. It includes breathing and secretions management exercises, building upper and lower extremity range of motion. Exercise progression should gradually incorporate aerobic exercises (treadmill, cycloergometer and upper and lower limb strength exercises) and limb strength training.~Aerobic exercise at moderate intensity (no more than 3-4/10 on the modified Borg scale). Aerobic exercise starting with 20 minutes and gradually increasing up to 30 minutes.~Limb strength training from 1 to 3 sets of 8-10 repetitions at moderate intensity.
Experimental: Experimental group: Conventional Rehabilitation Program + Inspiratory Muscle Training (IMT)
Standard rehabilitation program for 3 months, starting in the early phase in the ICU. A daily session from monday to friday. It includes breathing and secretions management exercises, building upper and lower extremity range of motion. Exercise progression should gradually incorporate aerobic exercises (treadmill, cycloergometer and upper and lower limb strength exercises) and limb strength training.~Aerobic exercise at moderate intensity (no more than 3-4/10 on the modified Borg scale). Aerobic exercise starting with 20 minutes and gradually increasing up to 30 minutes.~Limb strength training from 1 to 3 sets of 8-10 repetitions at moderate intensity.
Related Therapeutic Areas
Sponsors
Leads: Puerta de Hierro University Hospital
Collaborators: Universidad Complutense de Madrid

This content was sourced from clinicaltrials.gov