Benefits of Pulmonary Rehabilitation to Patients Post Liver Transplant

September 18, 2024 updated by: Hui-Ling Lin, Chang Gung University

The goal of this clinical trial was to access the benefits of a 12-week home-based pulmonary rehabilitation regimen on pulmonary function recovery in post-liver transplant patients. The main questions it aims to answer are:

Does pulmonary rehabilitation facilitate pulmonary muscle strength recovery? Does the intervention improve pulmonary function and reduce dyspnea sensation?

Participants performed:

Inspiratory muscle training twice a day for 12 weeks after discharged from the hospital Upper limb resistive training Lower limb exercise

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing liver transplantation often face significant challenges related to pulmonary rehabilitation. Although postoperative rehabilitation has been extensively studied, the specific role of pulmonary rehabilitation programs has received limited attention. This study aims to evaluate the efficacy of a home-based pulmonary rehabilitation program in improving respiratory function recovery among post-liver transplant patients. The training group participated in a 12-week pulmonary rehabilitation program post-discharge, emphasizing respiratory muscle and exercise training, while the control group received standard care, which included traditional rehabilitation.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 20 years or older
  • Scheduled to undergo living donor liver transplantation
  • Stable vital signs
  • Normal cognitive function
  • Able to perform activities independently using their own strength and coordination
  • Willing and able to participate in 12 weeks of rehabilitation training

Exclusion Criteria:

  • Severe physical illness during the operation
  • Acute bleeding
  • Unstable vital signs
  • Hepatic encephalopathy, or neurological conditions such as stroke, Parkinson's disease, or cognitive dysfunction
  • Limited mobility (e.g., unable to stand, lift upper limbs, or bedridden)
  • Inability to comply with 12 weeks of pulmonary rehabilitation post-discharge
  • Unstable vital signs
  • Hepatoencephalopathy, such as cardiovascular accident, Parkinson disease, cognitive dysfunction
  • Those with limited mobility (unable to stand, unable to lift upper limbs, or bedridden)
  • Those who are unable to cooperate with the 12 weeks of pulmonary rehabilitation exercises after discharge.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inspiratory Muscle Training group
Participants received a 12-week inspiratory muscle training and incentive spirometry therapy after discharged from hospital
Procedure: Inspiratory muscle Training
Participants underwent a 12-week program consisting of inspiratory muscle training twice daily, incentive spirometry three times daily, and upper limb exercises along with marching in place for 30 minutes.
Sham Comparator: Routine care
Participants received incentive spirometry therapy only
Procedure: Routine Care
Participants received routine care, which included encouragement to use incentive spirometry three times daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Muscle Stregnth Test
Time Frame: Throughout the study completion, approximately 3 month
Respiratory muscle strength was determined by Maximum Inspiratory Pressure (MIP) using a pressure monometer.
Throughout the study completion, approximately 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation status
Time Frame: Participants underwent maximum inspiratory and expiratory pressure measurements at four time points: upon admission, before discharge from the intensive care unit, before discharge from the hospital, and at the end of the 12-week enrollment period.
Oxygen saturation was monitored using a pulse oximeter.
Participants underwent maximum inspiratory and expiratory pressure measurements at four time points: upon admission, before discharge from the intensive care unit, before discharge from the hospital, and at the end of the 12-week enrollment period.
Dyspnea Severity Assessment
Time Frame: Throughout the study completion, approximately 3 month
Dyspnea severity was assessed by a rating of perceived exertion, using the Borg Scale which ranged from 0 (no respiratory difficulty) to 10 (extreme respiratory difficulty), with higher scores indicating more severe breathing difficulty.
Throughout the study completion, approximately 3 month
Forced Vital Capacity
Time Frame: Throughout the study completion, approximately 3 month
The forced vital capacity was obtained, using spirometry, by having the patient take a deep breath and then exhale forcefully. The test results were based on three reproducible measurements.
Throughout the study completion, approximately 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung University

Collaborators

Chang Gung Memorial Hospital
Chang Gung University of Science and Technology

Investigators

  • Principal Investigator: Jui-Fang Lin, PhD, Chang Gung University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202102058B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data is available upon request from the principal investigator.

IPD Sharing Time Frame

The data will become available 3 three years after the study is completed.

IPD Sharing Access Criteria

The data is available upon request from the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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