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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949505
• Other study ID #: QEUHB001
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: February 2020
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

as above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 1, 2018
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Diseases
• Liver Dysfunction

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth University Hospital Birmingham	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
Matthew Armstrong	Queen Elizabeth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional capacity - incremental shuttle walk test	incremental shuttle walk test	12-weeks
Other	Functional capacity - short performance battery test		12-weeks
Other	Psychological wellbeing - HADS questionnaire	HADS questionnaire	12-weeks
Other	Quality of Life - EQ-5D questionnaire	EQ-5D questionnaire	12-weeks
Primary	Number of participants with intervention-related adverse events as assessed by CTCAE v4.0	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	12-week