NCT02949505

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

October 25, 2016

Last Update Submit

February 6, 2020

Conditions

Liver CirrhosisLiver Dysfunction

Keywords

Prehabilitationliver transplantfunctional capacityexercise

Outcome Measures

Primary Outcomes (1)

  • 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

    12-week

Other Outcomes (4)

  • Functional capacity - incremental shuttle walk test

    12-weeks

  • Functional capacity - short performance battery test

    12-weeks

  • Psychological wellbeing - HADS questionnaire

    12-weeks

  • +1 more other outcomes

Study Arms (1)

Intervention arm

EXPERIMENTAL

12-week home prehabilitation program

Behavioral: Home prehabilitation program

Interventions

Home prehabilitation programBEHAVIORAL

12-week exercise therapy using daily step program (accelerometer), functional resistance exercise sessions and telephone/virtual clinic appointments

Intervention arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth University Hospital Birmingham

Birmingham, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29358444DERIVED

MeSH Terms

Conditions

Liver CirrhosisLiver DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Digestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • James Ferguson, phD

    Queen Elizabeth University Hospital Birmingham

    PRINCIPAL INVESTIGATOR

  • Felicity Williams

    Queen Elizabeth University Hospital Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator, Specialist Registrar in Hepatology and Honorary Clinical Fellow

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 31, 2016

Study Start

March 1, 2017

Primary Completion

October 1, 2017

Study Completion

August 1, 2018

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)