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

Primary Purpose

Liver Cirrhosis, Liver Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Home prehabilitation program
Sponsored by
Matthew Armstrong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Prehabilitation, liver transplant, functional capacity, exercise

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Elizabeth University Hospital Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

12-week home prehabilitation program

Outcomes

Primary Outcome Measures

Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
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

Secondary Outcome Measures

Full Information

First Posted
October 25, 2016
Last Updated
February 6, 2020
Sponsor
Matthew Armstrong
Collaborators
Queen Elizabeth Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02949505
Brief Title
Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation
Official Title
Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew Armstrong
Collaborators
Queen Elizabeth Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
Detailed Description
as above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Liver Dysfunction
Keywords
Prehabilitation, liver transplant, functional capacity, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
12-week home prehabilitation program
Intervention Type
Behavioral
Intervention Name(s)
Home prehabilitation program
Intervention Description
12-week exercise therapy using daily step program (accelerometer), functional resistance exercise sessions and telephone/virtual clinic appointments
Primary Outcome Measure Information:
Title
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
Description
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
Time Frame
12-week
Other Pre-specified Outcome Measures:
Title
Functional capacity - incremental shuttle walk test
Description
incremental shuttle walk test
Time Frame
12-weeks
Title
Functional capacity - short performance battery test
Time Frame
12-weeks
Title
Psychological wellbeing - HADS questionnaire
Description
HADS questionnaire
Time Frame
12-weeks
Title
Quality of Life - EQ-5D questionnaire
Description
EQ-5D questionnaire
Time Frame
12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Ferguson, phD
Organizational Affiliation
Queen Elizabeth University Hospital Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felicity Williams
Organizational Affiliation
Queen Elizabeth University Hospital Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth University Hospital Birmingham
City
Birmingham
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29358444
Citation
Williams FR, Vallance A, Faulkner T, Towey J, Kyte D, Durman S, Johnson J, Holt A, Perera MT, Ferguson J, Armstrong MJ. Home-based exercise therapy in patients awaiting liver transplantation: protocol for an observational feasibility trial. BMJ Open. 2018 Jan 21;8(1):e019298. doi: 10.1136/bmjopen-2017-019298.
Results Reference
derived

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

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