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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01162148
Enrollment
50
Registered
2010-07-14
Start date
2010-09-30
Completion date
2011-09-30
Last updated
2010-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplantation

Keywords

inspiratory muscle training, pulmonary rehabilitation

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: 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.

Interventions

BEHAVIORALConventional or regular pulmonary rehabilitation program alone

Conventional or regular pulmonary rehabilitation program alone

DEVICEvery low load IMT (sham IMT) alone

very low load IMT (sham IMT) alone

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

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

DEVICETargeted inspiratory resistive or threshold IMT alone

Targeted inspiratory resistive or threshold IMT alone

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
maximal exercise capacity9 months after starting interventionsat 9 months after starting interventions

Secondary

MeasureTime frameDescription
Lung function (FEV1, FVC)9 months after starting interventions9 months after starting interventions

Countries

Israel

Contacts

Primary ContactProf Mordechai R. Kramer M.D R Kramer, MD
kremerm@clalit.org.il972-39377221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026