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

Study Overview
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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.

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

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

Conditions
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Lung Transplantation

Intervention / Treatment
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* Behavioral: Conventional or regular pulmonary rehabilitation program alone
* Device: very low load IMT (sham IMT) alone
* Device: Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT
* Device: Targeted inspiratory resistive or threshold IMT alone


Participation Criteria
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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. Exclusion Criteria: Patients with cardiac disease,poor compliance,or requirement of supplemental oxygen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>conventional | Behavioral: Conventional or regular pulmonary rehabilitation program alone<br>* Conventional or regular pulmonary rehabilitation program alone<br>|
| Experimental: 2<br>sham IMT | Device: very low load IMT (sham IMT) alone<br>* very low load IMT (sham IMT) alone<br>|
| Experimental: 3<br>Conventional plus threshold IMT | Device: Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT<br>* Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT<br>|
| Experimental: 4<br>threshold IMT alone | Device: Targeted inspiratory resistive or threshold IMT alone<br>* Targeted inspiratory resistive or threshold IMT alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal exercise capacity | at 9 months after starting interventions | 9 months after starting interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function (FEV1, FVC) | 9 months after starting interventions | 9 months after starting interventions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inspiratory muscle training, pulmonary rehabilitation