EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-07

Study Completion Date

2020-07-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Primary Biliary Cholangitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm Exercise Intervention study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home-based Exercise Program

12-weeks, remotely monitored home-based exercise program consisting or aerobic and resistance exercise

Group Type EXPERIMENTAL

Home-based exercise program

Intervention Type OTHER

see 'arm' section

Interventions

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Home-based exercise program

see 'arm' section

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No