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

Not Applicable

Completed

• Conditions: Liver Cirrhosis; Liver Dysfunction
• Interventions: Behavioral: Home prehabilitation program

• Registration Number: NCT02949505
• Lead Sponsor: Matthew Armstrong

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

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-10-31
• Study Start: 2017-03-01
• Primary Completion: 2017-10-01
• Study Completion: 2018-08-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Home prehabilitation program	12-week home prehabilitation program

Primary Outcome Measures

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

Trial Locations

Locations (1)

Queen Elizabeth University Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom