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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01162148
First received: June 21, 2010
Last updated: July 13, 2010
Last verified: June 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • maximal exercise capacity [ Time Frame: 9 months after starting interventions ] [ Designated as safety issue: No ]
    at 9 months after starting interventions


Secondary Outcome Measures:
  • Lung function (FEV1, FVC) [ Time Frame: 9 months after starting interventions ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 21, 2010
Last Updated: July 13, 2010
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013