Home-based exercise and motivational programme before and after liver transplantation: ExaLT Trial
| ISRCTN | ISRCTN13476586 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13476586 |
| IRAS number | 295426 |
| Secondary identifying numbers | CPMS 52211, NIHR129318, IRAS 295426 |
- Submission date
- 12/05/2022
- Registration date
- 07/06/2022
- Last edited
- 10/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
Liver disease is the 3rd commonest cause of death in adults of working age and liver transplantation (LT) remains the only cure for liver failure. LT exerts a huge stress on the body and mind, especially in people who are already physically and mentally frail because of their liver disease. We know that being physically frailty prior to surgery results in a longer hospital stay because of postoperative complications and contributes to 1 in 10 patients either dying whilst still on the waiting list or shortly after LT. Exercise is one of the most powerful medical therapies available, with numerous proven benefits to patients with diseases like diabetes, heart disease and cancer. Despite this, exercise is not currently used in patients with liver failure or recovering from LT, due to a lack of robust evidence. Exercise may have the potential to improve the lives of people with liver disease and reduce the side-effects of LT surgery. The current standard of care for NHS patients awaiting LT is an advice leaflet. Evidence-based exercise programmes around the time of transplantation do not exist. Only a few small studies have indicated that supervised, hospital-based exercise can improve physical function and quality of life.
We aim to determine the effect of a home-based exercise and motivation-support programme in patients undergoing LT on their quality of life after surgery. We would also like to understand if exercise results in improvements in intricate measures of physical fitness and muscle function that account for changes in quality of life, and how the motivation-support component of the intervention enhances uptake and ongoing engagement of exercise pre and post LT.
Who can participate?
Patients with end-stage liver disease who are on the liver transplant waiting list.
What does the study involve?
We intend to perform a clinical trial, in which patients will be randomly allocated to receive either the home-based exercise/motivation support programme (intervention group) or a patient advice leaflet (control group) whilst on the LT waiting list. The intervention will begin whilst patients are on the LT waiting list and end 6 months after LT. The intervention will consist of regular strength and endurance exercises, tailored to each patient’s level of fitness. During clinic visits and via telephone calls a physiotherapist will provide motivational support throughout the exercise programme. The trial will involve recruiting 266 patients over two years from two LT hospitals in
England. We shall assess the effectiveness of the intervention by measuring quality of life before and after the study period in both groups of patients. The intervention will be deemed effective if quality of life scores are higher with the intervention than the control group.
What are the possible benefits and risks of participating?
We do not know how this trial will directly help participants, but it will help improve the care of patients with liver failure (and/or liver cancer), who are waiting or who have had a liver transplant. Participants may feel the indirect benefits of being part of this trial such as receive care which is not standard, improve the patient’s experience and knowledge of the liver disease process and receive closer monitoring and follow up. Participants may also feel empowered knowing that they contribution to clinical research will help advance new and improved treatments/services for patients undergoing a liver transplant.
The exercises that participants will be given to do will be matched to their ability and individualised to their needs, however there is still the possibility of sprains or injuries if the exercise are not carried out correctly. Participants can experience temporary pain/discomfort when they have blood taken and may develop a bruise at the site where the needle has sampled blood. To minimise this, additional blood tests for trial purposes will be taken (when possible) at the same time as blood tests as part of their routine clinical care.
In relation to an ongoing COVID pandemic, current government guidelines will be adhered to and local NHS and University procedures will be followed to minimise the risk of exposure to the virus.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
June 2021 to December 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dawn Brant, d.p.brant@bham.ac.uk
Contact information
Scientific
Birmingham Clinical Trials Unit (BCTU)
Institute of Applied Health Research
College of Medical and Dental Sciences
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| exalt@trials.bham.ac.uk |
Principal Investigator
University Hospitals Birmingham
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
| Phone | +44 121 3714673 |
|---|---|
| matthew.armstrong@uhb.nhs.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | http://www.birmingham.ac.uk/ExaLT |
| Scientific title | A phase IIb, randomised-controlled, two-centre clinical trial (ExaLT) on the efficacy of a home-based exercise and motivational programme in patients before and after liver transplantation |
| Study acronym | ExaLT |
| Study hypothesis | A remotely monitored ‘home-based exercise and theory based motivation support programme’ delivered by physiotherapists before and after liver transplantation (LT) (intervention group) improves the quality of life (physical component score of SF-36v2) in LT recipients compared to a control group using a patient ‘exercise’ advice leaflet (control group). |
| Ethics approval(s) |
Approved 01/04/2022, Hampshire A REC Board (Temple Quay House, 2 The Square, Temple Quay, Bristol, BS1 6PN, United Kingdom; +44 207 104 8196; hampshirea.rec@hra.nhs.uk), ref: 22/SC/0067 |
| Condition | Exercise before and after liver transplant |
| Intervention | Eligible participants will be randomised 1:1 to receive either: Group 1: Intervention group. Remotely-monitored home-based exercise and theory-based motivation support programme whilst on the LT waiting list (max. 12 months) through to 24 weeks post-LT. OR Group 2: Control group. Patient exercise advice leaflet before and after LT. The study intervention will be variable due to the unpredictable nature of the timing of Liver transplant (median waiting time 72 days (95% CI 64-80) registered between 2018-2021). All patients that are transplanted within 52 weeks of randomisation will receive a fixed 24 week intervention after Liver transplant (LT.) The visits are summarised below: Phase 1. Participants will attend the hospital (QEUHB or RFH) in line with their routine waiting list clinic appointment (where possible), at baseline line (visit 1), weeks 6 (visit 2), 12 (visit 3), 24 (visit 4), 36 (visit 5) and 48 (visit 6). At these visits, a repeat of the baseline assessment, including LFI and DASI, will be undertaken. The results of these assessments, review of the participant exercise diary and discussions with the participant themselves will be used to progress exercises and revise goals of their Home-based exercise programme (HBEP) if they are in the intervention arm. The end of the study intervention will be at 52 weeks if the participant has not undergone LT. At this stage, they will be asked if they wish to continue in the study (data collection). Post Liver Transplant: Phase 2 The trial physiotherapists will review the participant on the post-LT ward, within 48 hours of discharge from ICU. Within 48 hours prior discharge from hospital (or day 10 post-LT if not discharged by this point), a repeat of the baseline assessments, including LFI and DASI, will be undertaken on the ward Participants will then attend the hospital (QEUHB or RFH), in line with their routine post-LT follow-up clinic appointment (where possible), at weeks 6 post LT (visit 7), week 12 (visit 8), week 24 weeks (visit 9), 48 weeks (visit 10). At these visits, a repeat of the baseline assessment, including LFI and DASI, will be undertaken. Of note, Phase 2 of the HBEP will commence on day 1 of admission to the post-LT ward (i.e. within 24 hours of discharge from ICU) and end 24 weeks after the date of the LT surgery (visit 9). |
| Intervention type | Behavioural |
| Primary outcome measure | Physical component score (PCS) from the short form-36 version 2.0 (SF-36v2) health-related QoL questionnaire at 24 weeks post LT (scale 0-100). |
| Secondary outcome measures | Key secondary outcome measure: 1. Comprehensive Complication Index at 24 weeks post LT (scale 0-100). Other secondary outcome measures to be assessed at 24 weeks post LT (unless stated): 2. Mental Component Score (MCS) of SF-36v2 health-related QoL questionnaire 3. Liver Frailty Index (LFI), Duke Activity Score Index (DASI) 4. Pre-LT morbidity (UKELD, MELD-Na, hospital admissions) and mortality (*assessed up to day of LT) 5. Post-LT length of ICU/hospital stay and hospital re-admissions (frequency, duration [days]) 6. Post-LT 30, 90, 180 and 365 day mortality 7. Habitual physical activity levels (daily time spent in light, moderate and vigorous intensity physical activity) using Actigraph accelerometers 8. “Dose” of exercise completed (measure of the frequency, intensity and duration of exercise) 9. Adherence to Home-based exercise program (HBEP - intervention arm only) 10. Perceptions of the health care climate (how need supportive/empowering the physiotherapist is), measured using the Health Care Climate Questionnaire (HCCQ) 11. Basic psychological need satisfaction (i.e. feelings of autonomy, relatedness, competence), measured using the Basic Psychological Need Satisfaction in Exercise Scale (PNSE) 12. Self-determined motivation to exercise, using Behavioural Regulation in Exercise Questionaire-2 (BREQ-2) |
| Overall study start date | 09/06/2021 |
| Overall study end date | 03/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 266 |
| Total final enrolment | 269 |
| Participant inclusion criteria | 1. Adult Patients (aged 18 years or over) 2. Patients listed for a cadaveric, primary liver transplantation (LT) at QEUHB or the RFH 3. Being an out-patient at the time of baseline trial visit (consent) |
| Participant exclusion criteria | 1. Patient listed for Liver Transplant for any of the following reasons: 1.1. Super-urgent Liver Transplant (according to the Kings College criteria) 1.2. Multi-organ transplantation (e.g. combined liver and kidney transplant) 1.3. Live-related donor Liver Transplant 1.4. Re-graft Liver Transplant 2. Patients with an inability to safely comply with the exercise intervention due to the following conditions: 2.1. Severe hepatic encephalopathy (defined as grade 3 or 4; as judged by the principal or nominated co-investigators) 2.2. Oxygen-dependent hepato-pulmonary syndrome 3. Patients without liver failure, including: 3.1. Liver cancer in the absence of cirrhosis 3.2. Polycystic liver disease 3.3. Rare metabolic/genetic conditions (e.g. glycogen storage disorders) 4. Refusal or lacks capacity to give informed consent to participate in the trial, at the point of study visit 1 |
| Recruitment start date | 03/05/2022 |
| Recruitment end date | 28/05/2024 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
London
NW3 2QG
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Sponsor information
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 7814 650003 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 03/09/2024 | 10/09/2024 | Yes | No |
Editorial Notes
10/09/2024: Publication reference added.
17/06/2024: The following changes were made:
1. Total final enrolment was added.
2. The target number of participants was changed from "Planned Sample Size: 266; UK Sample Size: 266" to "266".
3. The recruitment end date was changed from 03/05/2024 to 28/05/2024.
4. The intention to publish date was changed from 01/11/2026 to 01/06/2027.
12/05/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
