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

Primary Purpose

Lung Transplantation

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Conventional or regular pulmonary rehabilitation program alone
very low load IMT (sham IMT) alone
Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT
Targeted inspiratory resistive or threshold IMT alone
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Transplantation focused on measuring inspiratory muscle training, pulmonary rehabilitation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pulmonary Institute Rabin Medical center, Beilinson Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

conventional

sham IMT

Conventional plus threshold IMT

threshold IMT alone

Outcomes

Primary Outcome Measures

maximal exercise capacity
at 9 months after starting interventions

Secondary Outcome Measures

Lung function (FEV1, FVC)
9 months after starting interventions

Full Information

First Posted
June 21, 2010
Last Updated
July 13, 2010
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01162148
Brief Title
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

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Conventional or regular pulmonary rehabilitation program alone(an exercise program that consist 3 main components: aerobic conditioning, resistance training, and flexibility exercises). Very low load IMT(sham IMT) alone. Conventional or regular pulmonary rehabilitation program + Targeted inspiratory resistive or threshold IMT. Targeted inspiratory resistive or threshold IMT alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplantation
Keywords
inspiratory muscle training, pulmonary rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
conventional
Arm Title
2
Arm Type
Experimental
Arm Description
sham IMT
Arm Title
3
Arm Type
Experimental
Arm Description
Conventional plus threshold IMT
Arm Title
4
Arm Type
Experimental
Arm Description
threshold IMT alone
Intervention Type
Behavioral
Intervention Name(s)
Conventional or regular pulmonary rehabilitation program alone
Intervention Description
Conventional or regular pulmonary rehabilitation program alone
Intervention Type
Device
Intervention Name(s)
very low load IMT (sham IMT) alone
Intervention Description
very low load IMT (sham IMT) alone
Intervention Type
Device
Intervention Name(s)
Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT
Intervention Description
Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT
Intervention Type
Device
Intervention Name(s)
Targeted inspiratory resistive or threshold IMT alone
Intervention Description
Targeted inspiratory resistive or threshold IMT alone
Primary Outcome Measure Information:
Title
maximal exercise capacity
Description
at 9 months after starting interventions
Time Frame
9 months after starting interventions
Secondary Outcome Measure Information:
Title
Lung function (FEV1, FVC)
Description
9 months after starting interventions
Time Frame
9 months after starting interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof Mordechai R. Kramer M.D R Kramer, MD
Phone
972-39377221
Email
kremerm@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordechai R Kramer, MD
Organizational Affiliation
Rabin Medical center, Beilinson Hospital Petach Tikva, 49100 Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Institute Rabin Medical center, Beilinson Hospital
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mordechai R Kramer, MD
Phone
972-39377221
Email
kremerm@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Mordechai R Kramer, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34282853
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.
Results Reference
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Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation

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