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

NCT01162148 | Unknown

• 1 other identifier: rab581710ctil
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation

Keywords

inspiratory muscle training; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• maximal exercise capacity

  at 9 months after starting interventions

  9 months after starting interventions

Secondary Outcomes (1)

• Lung function (FEV1, FVC)

  9 months after starting interventions

Study Arms (4)

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

Conventional or regular pulmonary rehabilitation program alone BEHAVIORAL

Conventional or regular pulmonary rehabilitation program alone

1

very low load IMT (sham IMT) alone DEVICE

very low load IMT (sham IMT) alone

2

Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT DEVICE

Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT

3

Targeted inspiratory resistive or threshold IMT alone DEVICE

Targeted inspiratory resistive or threshold IMT alone

4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with cardiac disease,poor compliance,or requirement of supplemental oxygen.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Pulmonary Institute Rabin Medical center, Beilinson Hospital

Petah Tikva, 49100, Israel

Location

Related Publications (1)

• 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.

  PMID: 34282853 DERIVED

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Mordechai R Kramer, MD

  Rabin Medical center, Beilinson Hospital Petach Tikva, 49100 Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof Mordechai R. Kramer M.D R Kramer, MD

CONTACT

972-39377221; kremerm@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: July 14, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: September 1, 2011
• Last Updated: July 14, 2010

Record last verified: 2010-06

Locations

IL (1)