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
|Condition or disease||Intervention/treatment||Phase|
|Primary Biliary Cholangitis||Other: Home-based exercise program||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm Exercise Intervention study|
|Masking:||None (Open Label)|
|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|
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
- 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)
- Health Anxiety Depression Score (HADS) [ Time Frame: 12 weeks ]Questionnaire - out of 24. higher score means worse depression and anxiety
- hand grips strength (kg) [ Time Frame: 12 weeks ]measures of muscle strength
- liver frailty index [ Time Frame: 12 weeks ]index based on hand grip strength, chair stands, balance. higher the value the more frail.
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
|Liver Unit, University Hospital Birminghmam|
|Birmingham, West Midlands, United Kingdom, B152TH|