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Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation

NCT01162148 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-07-14

No results posted yet for this study

Summary

Lung transplantation (LT) is now an established treatment option for patients with a wide variety of end-stage lung diseases- aims to improve quality of life and survival. Pulmonary rehabilitation (PR) is widely recognized as an important component of care of patients with chronic obstructive pulmonary disease (COPD), it improves dyspnea, exercise tolerance, quality of life, and reduces healthcare resource utilization.

The goal of pulmonary rehabilitation following lung transplantation is to enhance the physiological and functional benefits resulting from surgery. Inspiratory muscle Training (IMT) is defined as any intervention with the goal of training the inspiratory muscles. IMT can improve inspiratory muscles strength, endurance and exercise capacity in adults with COPD. IMT provides additional benefits to patients undergoing PR program and is worthwhile even in patients who have already undergone a general exercise reconditioning (GER) program. IMT will provide additional benefits (together or without) PR to patients following lung transplantation. No formal guidelines exist regarding the optimal methods of exercise training component of pulmonary rehabilitation for patients recovering from lung transplantation. This study will evaluate the unique influence of IMT in Patients Following Lung Transplantation.

Conditions

  • Lung Transplantation

Interventions

BEHAVIORAL

Conventional or regular pulmonary rehabilitation program alone

Conventional or regular pulmonary rehabilitation program alone

DEVICE

very low load IMT (sham IMT) alone

very low load IMT (sham IMT) alone

DEVICE

Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT

Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT

DEVICE

Targeted inspiratory resistive or threshold IMT alone

Targeted inspiratory resistive or threshold IMT alone

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Mordechai R Kramer, MD · Rabin Medical center, Beilinson Hospital Petach Tikva, 49100 Israel

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-12-31
Completion
2011-09-30

Countries

  • Israel

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 NCT01162148 on ClinicalTrials.gov