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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04265235
Recruitment Status : Terminated (COVID pandemic. Recruited 31 out of target 40 patients.)
First Posted : February 11, 2020
Last Update Posted : July 8, 2020
Sponsor:
Collaborators:
University Hospital Birmingham NHS Foundation Trust
Intercept Pharmaceuticals
Information provided by (Responsible Party):
Matthew Armstrong, University of Birmingham

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Biliary Cholangitis Other: Home-based exercise program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm Exercise Intervention study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study
Actual Study Start Date : April 7, 2019
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Health Anxiety Depression Score (HADS) [ Time Frame: 12 weeks ]
    Questionnaire - out of 24. higher score means worse depression and anxiety

  2. hand grips strength (kg) [ Time Frame: 12 weeks ]
    measures of muscle strength

  3. liver frailty index [ Time Frame: 12 weeks ]
    index based on hand grip strength, chair stands, balance. higher the value the more frail.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265235


Locations
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United Kingdom
Liver Unit, University Hospital Birminghmam
Birmingham, West Midlands, United Kingdom, B152TH
Sponsors and Collaborators
University of Birmingham
University Hospital Birmingham NHS Foundation Trust
Intercept Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Matthew Armstrong, Consultant in Liver and Transplant Medicine, Honorary Clinical research Fellow and Principal Investigator, University of Birmingham
ClinicalTrials.gov Identifier: NCT04265235    
Other Study ID Numbers: RRK6589
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Armstrong, University of Birmingham:
Exercise
Fatigue
Liver
Additional relevant MeSH terms:
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Liver Diseases
Cholangitis
Liver Cirrhosis, Biliary
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
 Cholestasis, Intrahepatic
Cholestasis
Liver Cirrhosis
Fibrosis
Pathologic Processes