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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Transplantation
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel, 49100
    • Pulmonary Institute Rabin Medical center, Beilinson Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; conventional	Behavioral: Conventional or regular pulmonary rehabilitation program alone; Conventional or regular pulmonary rehabilitation program alone
Experimental: 2; sham IMT	Device: very low load IMT (sham IMT) alone; very low load IMT (sham IMT) alone
Experimental: 3; Conventional plus threshold IMT	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
Experimental: 4; threshold IMT alone	Device: Targeted inspiratory resistive or threshold IMT alone; Targeted inspiratory resistive or threshold IMT alone

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Mordechai R Kramer, MD, Rabin Medical center, Beilinson Hospital Petach Tikva, 49100 Israel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: June 21, 2010
• First Submitted That Met QC Criteria: July 13, 2010
• First Posted (Estimate): July 14, 2010

Study Record Updates

• Last Update Posted (Estimate): July 14, 2010
• Last Update Submitted That Met QC Criteria: July 13, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; inspiratory muscle training
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: rab581710ctil