Liver CirrhosisNCT02949505
Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation
A study testing Home prehabilitation program in people with Liver Cirrhosis and Liver Dysfunction, run by Matthew Armstrong at 1 site in United Kingdom.
Trial summary
A UK prospective, single-centre feasibility study investigating the effects of exercise therapy on functional capacity in patients on the waiting list for liver transplantation. Patients will receive a 12-week home prehabilitation program (daily step program; functional resistance exercise sessions; telephone health… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Liver Dysfunction
- What is being tested?
- Home prehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2017to 1 Aug 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the United Kingdom Liver Transplant criteria for listing
- Accepted on the liver transplant waiting list for a primary transplant
- Adults ≥18years who have an indication for a liver transplant
- Diagnosed with sarcopenia at liver transplant assessment
Who cannot join
- Significant cardiovascular instability including a recent Myocardial infarction, recent Cerebrovascular accident and/or a recent unstable arrhythmia
- Unstable encephalopathy - open to interpretation by the chief investigator
- Patient or next of kin non-English speaking
- Inpatients
- Refusal or lacks capacity to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth University Hospital Birmingham
Birmingham
About this study
A UK prospective, single-centre feasibility study investigating the effects of exercise therapy on functional capacity in patients on the waiting list for liver transplantation. Patients will receive a 12-week home prehabilitation program (daily step program; functional resistance exercise sessions; telephone health call or virtual clinic). The following will be assessed at weeks 0, 6 and 12 weeks: feasibility (recruitment, compliance, safety, patients perception), functional capacity (ISWT, SPBT), psychological wellbeing (HADS questionnaire) and quality of life (EQ-5D)
Read the detailed description
as above
- Conditions
- Liver Cirrhosis, Liver Dysfunction
- Being tested
- Home prehabilitation program
- Keywords
- Prehabilitation, liver transplant, functional capacity, exercise
- Medical subject headings
- Liver Cirrhosis, Liver Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home prehabilitation programBehavioural
12-week exercise therapy using daily step program (accelerometer), functional resistance exercise sessions and telephone/virtual clinic appointments
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 12-week home prehabilitation program Receives: Behavioral: Home prehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
As this is a feasibility/Pilot study the investigators need to assess if any participants have any adverse events related to the home prehabilitation programme and if so, determine the severity and frequency
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start1 Mar 2017
- Primary completion1 Oct 2017
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Armstrong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth Hospital NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Matthew Armstrong, University of Birmingham
- Investigators
- James Ferguson, phD, Principal investigator, Queen Elizabeth University Hospital BirminghamFelicity Williams, Principal investigator, Queen Elizabeth University Hospital Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949505
- Sponsor's protocol ID
- QEUHB001
- Status last verified
- Feb 2020
- First submitted
- 25 Oct 2016
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Williams FR, Vallance A, Faulkner T, Towey J, Kyte D, Durman S, Johnson J, Holt A, Perera MT, Ferguson J, Armstrong MJ. Home-based exercise therapy in patients awaiting liver transplantation: protocol for an observational feasibility trial. BMJ Open. 2018 Jan 21;8(1):e019298. doi: 10.1136/bmjopen-2017-019298.
PubMed 29358444
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation
- ClinicalTrials.gov ID
- NCT02949505
- Acronym / sponsor ID
- QEUHB001
- Conditions
- Liver Cirrhosis, Liver Dysfunction
- Keywords
- Prehabilitation, liver transplant, functional capacity, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Matthew ArmstrongUniversity, hospital or other
- Collaborators
- Queen Elizabeth Hospital NHS Foundation Trust
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 31 Oct 2016 (estimated)
- 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 UK prospective, single-centre feasibility study investigating the effects of exercise therapy on functional capacity in patients on the waiting list for liver transplantation. Patients will receive a 12-week home prehabilitation program (daily step program; functional resistance exercise sessions; telephone health call or virtual clinic). The following will be assessed at weeks 0, 6 and 12 weeks: feasibility (recruitment, compliance, safety, patients perception), functional capacity (ISWT, SPBT), psychological wellbeing (HADS questionnaire) and quality of life (EQ-5D)
Detailed description
as above
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Home prehabilitation program12-week home prehabilitation program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the United Kingdom Liver Transplant criteria for listing
- Accepted on the liver transplant waiting list for a primary transplant
- Adults ≥18years who have an indication for a liver transplant
- Diagnosed with sarcopenia at liver transplant assessment
Key exclusion criteria (5 listed)
- Significant cardiovascular instability including a recent Myocardial infarction, recent Cerebrovascular accident and/or a recent unstable arrhythmia
- Unstable encephalopathy - open to interpretation by the chief investigator
- Patient or next of kin non-English speaking
- Inpatients
- Refusal or lacks capacity to give informed consent
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 prehabilitation program12-week exercise therapy using daily step program (accelerometer), functional resistance exercise sessions and telephone/virtual clinic appointments | Behavioural | Intervention arm |
Primary outcome
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
Time frame: 12-week
As this is a feasibility/Pilot study the investigators need to assess if any participants have any adverse events related to the home prehabilitation programme and if so, determine the severity and frequency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Derived from this study: PubMed 29358444Williams FR, Vallance A, Faulkner T, Towey J, Kyte D, Durman S, Johnson J, Holt A, Perera MT, Ferguson J, Armstrong MJ. Home-based exercise therapy in patients awaiting liver transplantation: protocol for an observational feasibility trial. BMJ Open. 2018 Jan 21;8(1):e019298. doi: 10.1136/bmjopen-2017-019298.
- Individual participant dataSharing planned: No
Related trials for Liver Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
James Ferguson, phD principal investigator
Queen Elizabeth University Hospital Birmingham
Felicity Williams principal investigator
Queen Elizabeth University Hospital Birmingham
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 prehabilitation program in people with Liver Cirrhosis and Liver Dysfunction, run by Matthew Armstrong 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 5 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: finished, as of the sponsor's last update on 7 Feb 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0 (time frame: 12-week). 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 NCT02949505, which also lists 1 linked publication.
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 7 Feb 2020.