EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study

Study Overview
=================
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.

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

Official Title
-----------------
EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study

Conditions
-----------------
Primary Biliary Cholangitis

Intervention / Treatment
-----------------
* Other: Home-based exercise program


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm Exercise Intervention study
Masking: None (Open Label)


Arms and Interventions

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

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 | 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) | Questionnaire - out of 24. higher score means worse depression and anxiety | 12 weeks | 
| hand grips strength (kg) | measures of muscle strength | 12 weeks | 
| liver frailty index | index based on hand grip strength, chair stands, balance. higher the value the more frail. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Fatigue, Liver