Benefits of Pulmonary Rehabilitation to Patients Post Liver Transplant

NCT06606184 | Completed

• 1 other identifier: 202102058B0
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Transplant Surgery

Keywords

liver transplant; pulmonary rehabilitation; inspiratory muscle training; inspiratory muscle strength; Dyspnea

Outcome Measures

Primary Outcomes (1)

• Respiratory Muscle Stregnth Test

  Respiratory muscle strength was determined by Maximum Inspiratory Pressure (MIP) using a pressure monometer.

  Throughout the study completion, approximately 3 month

Secondary Outcomes (3)

• Oxygenation status

  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

  Throughout the study completion, approximately 3 month

• Forced Vital Capacity

  Throughout the study completion, approximately 3 month

Study Arms (2)

Inspiratory Muscle Training group

EXPERIMENTAL

Participants received a 12-week inspiratory muscle training and incentive spirometry therapy after discharged from hospital

Procedure: Inspiratory muscle Training

Routine care

SHAM COMPARATOR

Participants received incentive spirometry therapy only

Procedure: Routine Care

Interventions

Inspiratory muscle Training PROCEDURE

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.

Inspiratory Muscle Training group

Routine Care PROCEDURE

Participants received routine care, which included encouragement to use incentive spirometry three times daily.

Routine care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung University: lead
• Chang Gung University of Science and Technology: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (2)

• Au KP, Chan SC, Chok KS, Sharr WW, Dai WC, Sin SL, Wong TC, Lo CM. Clinical factors affecting rejection rates in liver transplantation. Hepatobiliary Pancreat Dis Int. 2015 Aug;14(4):367-73. doi: 10.1016/s1499-3872(15)60391-5.

  PMID: 26256080 BACKGROUND

• Aamir,T., Iftikhar,S., Khan, R.R., &Khan, M.K (2019).Role of physiotherapy in improving quality Of life in liver transpant patients. The Rehabilitation Journal, 3(2),126-130.

  BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jui-Fang Lin, PhD

  Chang Gung University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 20, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available 3 three years after the study is completed.
• Access Criteria: The data is available upon request from the principal investigator.

Locations

TW (1)