Clinical trial NCT02949505: Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation
Official title: Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Liver Dysfunction
Keywords: Prehabilitation
liver transplant
functional capacity
exercise
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Queen Elizabeth Hospital NHS Foundation Trust
First posted: 2016-10-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
timeFrame: 12-week
Secondary outcomes:
Other outcomes:
measure: Functional capacity - incremental shuttle walk test
timeFrame: 12-weeks
measure: Functional capacity - short performance battery test
timeFrame: 12-weeks
measure: Psychological wellbeing - HADS questionnaire
timeFrame: 12-weeks
measure: Quality of Life - EQ-5D questionnaire
timeFrame: 12-weeks
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth University Hospital Birmingham
Study officials:
affiliation: Queen Elizabeth University Hospital Birmingham
name: James Ferguson, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Elizabeth University Hospital Birmingham
name: Felicity Williams
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.