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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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The post lung transplant patients will participate in a rehabilitation program for 6 months. Participants in the proposed study will belong to one of four intervention groups:

1. Conventional or regular pulmonary rehabilitation program alone(an exercise program that consist 3 main components: aerobic conditioning, resistance training, and flexibility exercises).
2. Very low load IMT(sham IMT) alone.
3. Conventional or regular pulmonary rehabilitation program + Targeted inspiratory resistive or threshold IMT.
4. Targeted inspiratory resistive or threshold IMT alone.

Conditions

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Lung Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

conventional

Group Type EXPERIMENTAL

Conventional or regular pulmonary rehabilitation program alone

Intervention Type BEHAVIORAL

Conventional or regular pulmonary rehabilitation program alone

2

sham IMT

Group Type EXPERIMENTAL

very low load IMT (sham IMT) alone

Intervention Type DEVICE

very low load IMT (sham IMT) alone

3

Conventional plus threshold IMT

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

4

threshold IMT alone

Group Type EXPERIMENTAL

Targeted inspiratory resistive or threshold IMT alone

Intervention Type DEVICE

Targeted inspiratory resistive or threshold IMT alone

Interventions

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Conventional or regular pulmonary rehabilitation program alone

Intervention Type BEHAVIORAL

very low load IMT (sham IMT) alone

Intervention Type DEVICE

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

Intervention Type DEVICE

Targeted inspiratory resistive or threshold IMT alone

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Post lung transplant patients attending the pulmonary Institute , will be invited to participate,They will be co-operative and able to perform spirometry; and other lung tests.
* Patients will be stable clinically,for at least one month,the patients will be all new to an IMT program.