EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study (EXCITED)

July 5, 2020 updated by: Matthew Armstrong, University of Birmingham
A prospective, single centre, single-arm, pilot study investigating the safety and efficacy of a 12-week remotely-monitored home-based exercise program in patients with refractory fatigue (based on PBC-40 Quality of Life measure) secondary to Primary Biliary Cirrhosis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Recruitment from the research nurse-led PBC clinic: Eligibility screen followed by recruitment letters being sent to patients.

The outpatient clinic review by the liver specialist physiotherapist (week 0):

Patients will undergo a baseline assessment of quality of life, anthropometry, functional capacity (with validated tools including the incremental shuttle walk test and short performance battery test) and exercise tolerance. At the same visit, patients will be prescribed and trained to perform the individualised Home-based Exercise Program. Patients will be provided with an accelerometer to assess daily step count and a symptoms/side effects diary.

Six weeks of telephone support (weeks 0-6):

Patients will be telephoned weekly over a period of 6 weeks, in order to evaluate compliance with therapy and any difficulties encountered. At each phone call, the daily step count and the intensity of the resistance-exercises will be adjusted to the patients ability.

The outpatient clinic review by the liver specialist physiotherapist (week 6 +/- 5 days): Reassessment of baseline parameters of quality of life, functionality and exercise tolerance; and modification of step count targets and resistance-exercise intervention as needed.

The outpatient clinic review by the liver specialist physiotherapist (week 12 +/- 5 days): Reassessment of baseline parameters of quality of life, functionality and exercise tolerance; and modification of step count targets and resistance-exercise intervention as needed.

Validate the efficacy of exercise intervention: Given that the goal is to improve fatigue-related symptoms and thus patient quality of life, the investigators will determine the interim efficacy and longevity of intervention using a multi-modal patient-reported outcome approach. This will principally be through changes in validated quality of life (QoL) scoring measures at baseline and during sequential study visits; including the fatigue domain of the PBC-40 QoL measure (primary outcome measure), in addition to the relevant PBC-40 domains of cognitive, social, emotional and overall symptom burden; the Hospital Anxiety and Depression Scale (HADS); Epworth Sleepiness Scale to assess daytime somnolence; Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS-HAQ®) to assess functional status, and the Cognitive Failure questionnaire (COGFAIL) to determine cognitive functionality.

All data will be collated onto a standardised clinical case record form. Outcomes will be audited after 6 months to determine whether the intervention has proven beneficial to patients, and whether improvements in functional status correlate with changes in fatigue and QoL scores

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B152TH
        • Liver Unit, University Hospital Birminghmam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 Years Old
  • A confirmed diagnosis of PBC through clinical observation as per guidance of BSG/ EASL
  • Fatigue Impact Scale >40
  • Access to a SMART Phone or Computer

Exclusion Criteria:

  • Decompensated PBC with the following clinical signs:
  • Moderate Ascites
  • A Bilirubin of >50
  • Variceal Bleed < 6 Months
  • Encephalopathic
  • Refractory Pruritis (Judged by PI)
  • Cardiovascular Instability (Judged by PI)
  • Untreated Vitamin Deficiency
  • Untreated hypothyroidism
  • Untreated Coeliac Disease
  • WHO Performance Status > 3
  • History of Unexplained Falls

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-based Exercise Program
12-weeks, remotely monitored home-based exercise program consisting or aerobic and resistance exercise
Other: Home-based exercise program
see 'arm' section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PBC-40 Quality of Life for Primary Biliary Cirrhosis
Time Frame: 12 weeks
PBC-40 is a quality of life questionnaire (validated) with the domains of cognitive, social, emotional and overall symptom burden. 40 questions, each scored on a scale of 1 to 5 (where 1 = least impact, 5 = greatest impact)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Anxiety Depression Score (HADS)
Time Frame: 12 weeks
Questionnaire - out of 24. higher score means worse depression and anxiety
12 weeks
hand grips strength (kg)
Time Frame: 12 weeks
measures of muscle strength
12 weeks
liver frailty index
Time Frame: 12 weeks
index based on hand grip strength, chair stands, balance. higher the value the more frail.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

University Hospital Birmingham NHS Foundation Trust
Intercept Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2019

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 5, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK6589

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Biliary Cholangitis

Clinical Trials on Home-based exercise program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe