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NCT Number: NCT02949505

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

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)

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Key information

Conditions

Liver Cirrhosis Behavior Digestive System Diseases Fibrosis Liver Diseases Liver Dysfunction Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth University Hospital Birmingham

Birmingham, United Kingdom

About this study

as above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home prehabilitation program

Behavioral

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

Primary outcomes

  1. 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

Other outcomes

  1. Functional capacity - incremental shuttle walk test

    Time frame: 12-weeks

    incremental shuttle walk test

  2. Functional capacity - short performance battery test

    Time frame: 12-weeks

  3. Psychological wellbeing - HADS questionnaire

    Time frame: 12-weeks

    HADS questionnaire

  4. Quality of Life - EQ-5D questionnaire

    Time frame: 12-weeks

    EQ-5D questionnaire

Sponsors and collaborators

Lead sponsor

Matthew Armstrong

Other

Collaborators

  • Queen Elizabeth Hospital NHS Foundation Trust

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 31, 2016
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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