Primary Biliary CholangitisEXCITEDNCT04265235
EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study
A study testing Home-based exercise program in people with Primary Biliary Cholangitis, run by University of Birmingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- Home-based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Apr 2019to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Decompensated PBC with the following clinical signs:
- Moderate Ascites
- A Bilirubin of >50
- Variceal Bleed < 6 Months
- Encephalopathic
- Refractory Pruritis (Judged by PI)
Show all 12Show fewer
- Cardiovascular Instability (Judged by PI)
- Untreated Vitamin Deficiency
- Untreated hypothyroidism
- Untreated Coeliac Disease
- WHO Performance Status > 3
- History of Unexplained Falls
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liver Unit, University Hospital Birminghmam
Birmingham, West Midlands, B152TH
About this study
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.
Read the 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
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Home-based exercise program
- Keywords
- Exercise, Fatigue, Liver
- Medical subject headings
- Liver Cirrhosis, Biliary, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exercise programOther
see 'arm' section
| Study group | Role | What they receive |
|---|---|---|
| Home-based Exercise Program | Experimental | 12-weeks, remotely monitored home-based exercise program consisting or aerobic and resistance exercise Receives: Other: Home-based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (3)
Health Anxiety Depression Score (HADS)
Questionnaire - out of 24. higher score means worse depression and anxiety
Measured: 12 weeks
hand grips strength (kg)
measures of muscle strength
Measured: 12 weeks
liver frailty index
index based on hand grip strength, chair stands, balance. higher the value the more frail.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start7 Apr 2019
- Primary completion30 Mar 2020
- Study completion1 Jul 2020
Why it stopped: COVID pandemic. Recruited 31 out of target 40 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm Exercise Intervention study
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham NHS Foundation Trust, Intercept Pharmaceuticals
- Responsible party
- Principal investigator, Matthew Armstrong, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265235
- Sponsor's protocol ID
- RRK6589
- Acronym
- EXCITED
- Status last verified
- Jul 2020
- First submitted
- 6 Feb 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39640219Freer 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.
PubMed 33707216
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study
- ClinicalTrials.gov ID
- NCT04265235
- Acronym / sponsor ID
- EXCITED / RRK6589
- Conditions
- Primary Biliary Cholangitis
- Keywords
- Exercise, Fatigue, Liver
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID pandemic. Recruited 31 out of target 40 patients.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- University Hospital Birmingham NHS Foundation Trust, Intercept Pharmaceuticals
- Study start
- 7 Apr 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm Exercise Intervention study
| Arm | Type | Receives |
|---|---|---|
| Home-based Exercise Program | Experimental | Other: Home-based exercise program12-weeks, remotely monitored home-based exercise program consisting or aerobic and resistance exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Decompensated PBC with the following clinical signs:
- Moderate Ascites
- A Bilirubin of >50
- Variceal Bleed < 6 Months
- Encephalopathic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exercise programsee 'arm' section | Other | Home-based Exercise Program |
Primary outcome
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)
3 secondary outcomes
Health Anxiety Depression Score (HADS)
Time frame: 12 weeks
hand grips strength (kg)
Time frame: 12 weeks
liver frailty index
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: COVID pandemic. Recruited 31 out of target 40 patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 39640219Freer 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.
- Derived from this study: PubMed 33707216Freer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise program in people with Primary Biliary Cholangitis, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID pandemic. Recruited 31 out of target 40 patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PBC-40 Quality of Life for Primary Biliary Cirrhosis (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04265235, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.