Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation

February 6, 2020 updated by: Matthew Armstrong
A UK prospective, single-centre feasibility study investigating the effects of exercise therapy on functional capacity in patients on the waiting list for liver transplantation. Patients will receive a 12-week home prehabilitation program (daily step program; functional resistance exercise sessions; telephone health call or virtual clinic). The following will be assessed at weeks 0, 6 and 12 weeks: feasibility (recruitment, compliance, safety, patients perception), functional capacity (ISWT, SPBT), psychological wellbeing (HADS questionnaire) and quality of life (EQ-5D)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

as above

Study Type

Interventional

Enrollment (Actual)

18

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

  • United Kingdom
      • Birmingham, United Kingdom
        • Queen Elizabeth University Hospital Birmingham

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet the United Kingdom Liver Transplant criteria for listing
  • Accepted on the liver transplant waiting list for a primary transplant
  • Adults ≥18years who have an indication for a liver transplant
  • Diagnosed with sarcopenia at liver transplant assessment

Exclusion Criteria:

  • Significant cardiovascular instability including a recent Myocardial infarction, recent Cerebrovascular accident and/or a recent unstable arrhythmia
  • Unstable encephalopathy - open to interpretation by the chief investigator
  • Patient or next of kin non-English speaking
  • Inpatients
  • Refusal or lacks capacity to give informed consent

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
12-week home prehabilitation program
Behavioral: Home prehabilitation program
12-week exercise therapy using daily step program (accelerometer), functional resistance exercise sessions and telephone/virtual clinic appointments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
Time Frame: 12-week
As this is a feasibility/Pilot study the investigators need to assess if any participants have any adverse events related to the home prehabilitation programme and if so, determine the severity and frequency
12-week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity - incremental shuttle walk test
Time Frame: 12-weeks
incremental shuttle walk test
12-weeks
Functional capacity - short performance battery test
Time Frame: 12-weeks
12-weeks
Psychological wellbeing - HADS questionnaire
Time Frame: 12-weeks
HADS questionnaire
12-weeks
Quality of Life - EQ-5D questionnaire
Time Frame: 12-weeks
EQ-5D questionnaire
12-weeks

Collaborators and Investigators

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

Sponsor

Matthew Armstrong

Collaborators

Queen Elizabeth Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: James Ferguson, phD, Queen Elizabeth University Hospital Birmingham
  • Principal Investigator: Felicity Williams, Queen Elizabeth University Hospital Birmingham

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)

March 1, 2017

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 28, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QEUHB001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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