Clinical trial NCT01162148: Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation
Official title: Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Transplantation
Keywords: inspiratory muscle training
pulmonary rehabilitation
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: maximal exercise capacity
timeFrame: 9 months after starting interventions
Secondary outcomes:
measure: Lung function (FEV1, FVC)
timeFrame: 9 months after starting interventions
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Pulmonary Institute Rabin Medical center, Beilinson Hospital
Study officials:
affiliation: Rabin Medical center, Beilinson Hospital Petach Tikva, 49100 Israel
name: Mordechai R Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.