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

Clalit Health Services

Status: Unknown

Conditions: Lung Transplantation

Treatments: Device: Targeted inspiratory resistive or threshold IMT alone; Device: Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT; Behavioral: Conventional or regular pulmonary rehabilitation program alone; Device: very low load IMT (sham IMT) alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01162148

rab581710ctil

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 4 patient groups

1

Experimental group

Description:

conventional

Treatment:

Behavioral: Conventional or regular pulmonary rehabilitation program alone

2

Experimental group

Description:

sham IMT

Treatment:

Device: very low load IMT (sham IMT) alone

3

Experimental group

Description:

Conventional plus threshold IMT

Treatment:

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

4

Experimental group

Description:

threshold IMT alone

Treatment:

Device: Targeted inspiratory resistive or threshold IMT alone