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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01162148
First Posted: July 14, 2010
Last Update Posted: July 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rabin Medical Center
  Purpose

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.


Condition Intervention
Lung Transplantation 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • maximal exercise capacity [ Time Frame: 9 months after starting interventions ]
    at 9 months after starting interventions


Secondary Outcome Measures:
  • Lung function (FEV1, FVC) [ Time Frame: 9 months after starting interventions ]
    9 months after starting interventions


Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162148


Contacts
Contact: Prof Mordechai R. Kramer M.D R Kramer, MD 972-39377221 kremerm@clalit.org.il

Locations
Israel
Pulmonary Institute Rabin Medical center, Beilinson Hospital Not yet recruiting
Petach Tikva, Israel, 49100
Contact: Mordechai R Kramer, MD    972-39377221    kremerm@clalit.org.il   
Principal Investigator: Mordechai R Kramer, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Mordechai R Kramer, MD Rabin Medical center, Beilinson Hospital Petach Tikva, 49100 Israel
  More Information

Responsible Party: Prof Mordechai R. Kramer M.D, Rabin Medical center, Beilinson Hospital Petach Tikva, 49100 Israel
ClinicalTrials.gov Identifier: NCT01162148     History of Changes
Other Study ID Numbers: rab581710ctil
First Submitted: June 21, 2010
First Posted: July 14, 2010
Last Update Posted: July 14, 2010
Last Verified: June 2010

Keywords provided by Rabin Medical Center:
inspiratory muscle training
pulmonary rehabilitation

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes