NCT04265235

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

February 6, 2020

Last Update Submit

July 5, 2020

Conditions

Primary Biliary Cholangitis

Keywords

ExerciseFatigueLiver

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Health Anxiety Depression Score (HADS)

    12 weeks

  • hand grips strength (kg)

    12 weeks

  • liver frailty index

    12 weeks

Study Arms (1)

Home-based Exercise Program

EXPERIMENTAL

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

Other: Home-based exercise program

Interventions

Home-based exercise programOTHER

see 'arm' section

Home-based Exercise Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver Unit, University Hospital Birminghmam

Birmingham, West Midlands, B152TH, United Kingdom

Location

Related Publications (2)

  • Freer A, Williams FR, Durman S, Hayden J, Armstrong MJ, Trivedi PJ. A home-based exercise programme attenuates fatigue in primary biliary cholangitis: Results from the EXCITED clinical trial. JHEP Rep. 2024 Sep 6;6(12):101210. doi: 10.1016/j.jhepr.2024.101210. eCollection 2024 Dec.

    PMID: 39640219DERIVED

  • Freer A, Williams F, Durman S, Hayden J, Trivedi PJ, Armstrong MJ. Home-based exercise in patients with refractory fatigue associated with primary biliary cholangitis: a protocol for the EXerCise Intervention in cholesTatic LivEr Disease (EXCITED) feasibility trial. BMJ Open Gastroenterol. 2021 Mar;8(1):e000579. doi: 10.1136/bmjgast-2020-000579.

    PMID: 33707216DERIVED

MeSH Terms

Conditions

Liver Cirrhosis, BiliaryMotor ActivityFatigue

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-arm Exercise Intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Liver and Transplant Medicine, Honorary Clinical research Fellow and Principal Investigator

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 11, 2020

Study Start

April 7, 2019

Primary Completion

March 30, 2020

Study Completion

July 1, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)