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Clinical Trials/NCT02949505
NCT02949505
Completed
N/A

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

Matthew Armstrong1 site in 1 country18 target enrollmentMarch 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Liver Cirrhosis
Sponsor
Matthew Armstrong
Enrollment
18
Locations
1
Primary Endpoint
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
Status
Completed
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
August 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Matthew Armstrong
Responsible Party
Sponsor Investigator
Principal Investigator

Matthew Armstrong

Principal investigator, Specialist Registrar in Hepatology and Honorary Clinical Fellow

University of Birmingham

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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