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

• Sponsor: Matthew Armstrong (Other)
• Overall Status: Completed
• CT.gov ID: NCT02949505
• Collaborator: Queen Elizabeth Hospital NHS Foundation Trust (Other)
• Enrollment: 18
• Location: 1
• Arm: 1
• Actual Duration (Months): 17
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis; Liver Dysfunction	Behavioral: Home prehabilitation program	N/A

Detailed Description

as above

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm 12-week home prehabilitation program	Behavioral: Home prehabilitation program; 12-week exercise therapy using daily step program (accelerometer), functional resistance exercise sessions and telephone/virtual clinic appointments

Outcome Measures

Primary Outcome Measures

1. 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

Other Outcome Measures

1. Functional capacity - incremental shuttle walk test [12-weeks]

   incremental shuttle walk test

2. Functional capacity - short performance battery test [12-weeks]

3. Psychological wellbeing - HADS questionnaire [12-weeks]

   HADS questionnaire

4. Quality of Life - EQ-5D questionnaire [12-weeks]

   EQ-5D questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth University Hospital Birmingham	Birmingham		United Kingdom

Sponsors and Collaborators

• Matthew Armstrong
• Queen Elizabeth Hospital NHS Foundation Trust

Investigators

• Principal Investigator: James Ferguson, phD, Queen Elizabeth University Hospital Birmingham
• Principal Investigator: Felicity Williams, Queen Elizabeth University Hospital Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthew Armstrong, Principal investigator, Specialist Registrar in Hepatology and Honorary Clinical Fellow, University of Birmingham
• ClinicalTrials.gov Identifier: NCT02949505
• Other Study ID Numbers: QEUHB001
• First Posted: Oct 31, 2016
• Last Update Posted: Feb 7, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Matthew Armstrong, Principal investigator, Specialist Registrar in Hepatology and Honorary Clinical Fellow, University of Birmingham: Prehabilitation; liver transplant; functional capacity; exercise
• Additional relevant MeSH terms: Liver Cirrhosis; Liver Diseases

Study Results

No Results Posted as of Feb 7, 2020