Pulmonary Rehabilitation and Inspiratory Muscle Training... | NCT01162148

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

NCT01162148

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Jul 14, 2010Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Lung Transplantation

Interventions

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

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Dec 2010Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Jun 21, 2010

First Submission Date that Met QC Criteria

Jul 13, 2010

First Posted Date

Jul 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2010

Last Update Posted Date

Jul 14, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Rabin Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	conventional	Behavioral: Conventional or regular pulmonary rehabilitation program alone
2	Experimental	sham IMT	Device: very low load IMT (sham IMT) alone
3	Experimental	Conventional plus threshold IMT	Device: Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT
4	Experimental	threshold IMT alone	Device: Targeted inspiratory resistive or threshold IMT alone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conventional or regular pulmonary rehabilitation program alone	Behavioral	Conventional or regular pulmonary rehabilitation program alone	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
maximal exercise capacity	at 9 months after starting interventions	9 months after starting interventions

Secondary Outcomes

Measure	Description	Time Frame
Lung function (FEV1, FVC)	9 months after starting interventions	9 months after starting interventions

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Prof Mordechai R. Kramer M.D R Kramer, MD	Contact	972-39377221		kremerm@clalit.org.il

Overall Officials

Name	Affiliation	Role
Mordechai R Kramer, MD	Rabin Medical center, Beilinson Hospital Petach Tikva, 49100 Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary Institute Rabin Medical center, Beilinson Hospital		Petah Tikva		49100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34282853	Derived	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.

ID	Term
D009938	Organizations
D004472	Health Care Economics and Organizations