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

NCT ID: NCT02949505

Last Updated: 2020-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-08-01

Brief Summary

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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

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as above

Conditions

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Liver Cirrhosis Liver Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention arm

12-week home prehabilitation program

Group Type EXPERIMENTAL

Home prehabilitation program

Intervention Type BEHAVIORAL

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

Interventions

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Home prehabilitation program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Elizabeth Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

Matthew Armstrong

OTHER

Sponsor Role lead

Responsible Party

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Matthew Armstrong

Principal investigator, Specialist Registrar in Hepatology and Honorary Clinical Fellow

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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James Ferguson, phD

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth University Hospital Birmingham

Felicity Williams

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth University Hospital Birmingham

Locations

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Queen Elizabeth University Hospital Birmingham

Birmingham, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 29358444 (View on PubMed)

Other Identifiers

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QEUHB001

Identifier Type: -

Identifier Source: org_study_id

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