Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Matthew Armstrong
Principal investigator, Specialist Registrar in Hepatology and Honorary Clinical Fellow
University of Birmingham