Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000791639
Ethics application status
Approved
Date submitted
11/07/2014
Date registered
25/07/2014
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Date results information initially provided
4/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise training in patients awaiting a liver transplantation: a randomised control trial
Scientific title
Examining the safety, feasibility and efficacy of an exercise-training program in patients awaiting a liver transplantation: a randomised controlled trial.
Secondary ID [1] 284967 0
Nil
Universal Trial Number (UTN)
U1111-1159-1968
Trial acronym
FITx
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Transplant 292465 0
Exercise Training 292466 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292779 292779 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomized control trial will examine the safety and feasibility of an exercise-training program in liver transplant candidates. The primary outcomes for the study are to determine whether an exercise-training program is safe (as measured by number of reported adverse events) and feasible (as measured by adherence to the training program). The secondary outcomes from the study are to investigate the efficacy of exercise training on the VT, VO2peak, 6MWT, muscular strength, systemic endothelial function, autonomic function, physical activity, liver disease specific health-related quality of life and blood variables.

The study cohort will aim to include 30 liver transplant candidates (patients with end stage liver disease requiring a liver transplant for survival) with 15 participants assigned to the intervention arm. An Accredited Exercise Physiologist will supervised all exercise training sessions. All supervised exercise sessions will be performed in a clinical research gym.

Participants will be randomly assigned to either the exercise intervention group or the control group. The exercise intervention will consist of two, one-hour supervised sessions and one, one-hour unsupervised session per week for 8 weeks. Participant baseline measures will be retested mid-intervention (4 weeks) and a week following completion of the intervention (8 weeks). Participants will also be followed up every three months with baseline testing repeated until transplantation. The exercise intervention will combine both aerobic and resistance based training in a circuit-style program. Aerobic training will be completed on a self-selected cardiovascular training apparatus (e.g. treadmill, cycle ergometer, arm ergometer). For resistance training, major muscle groups will be targeted using machine-based weights, dumbbells, Therabands and body weight exercises. The prescription for the one unsupervised, home-based session will replicate the duration and type of exercise of the supervised sessions (i.e. Duration: 1 hour, type: aerobic and resistance based circuit exercise training). Adherence to the exercise training will be monitored using an exercise diary and participants will be asked to record all exercise completed during the intervention in the diary. This information will also be clarified at the supervised exercise sessions.

Participants will complete a 5-minute warm up on a self-selected cardiovascular training apparatus (e.g. treadmill, cycle ergometer, arm ergometer) at a heart rate corresponding to approximately 80% ventilatory threshold (VT) (RPE 10/20, ranging between 55-80% HRmax). Participants will then perform an individualized circuit weight training (CWT) program at a heart rate value corresponding to VT (RPE 11-13). Each circuit will consist of 8-10 resistance exercises. Following each circuit, a period of active recovery for 2-3 minutes on a self-selected cardiovascular training apparatus (e.g. treadmill, cycle ergometer, arm ergometer) at a heart rate corresponding to approximately 70% VT (RPE 10/20, ranging between 55-80% HRmax). Following the CWT program, participants will complete a 5-minute warm down on a self-selected cardiovascular training apparatus (e.g. treadmill, cycle ergometer, arm ergometer) at a heart rate corresponding to approximately 70% VT (RPE 9/20, ranging between 55-80% HRmax).
Intervention code [1] 289799 0
Rehabilitation
Comparator / control treatment
A total of 15 patients will assigned to the control group. They will continue to receive usual care as per their listing for liver transplantation.
Control group
Active

Outcomes
Primary outcome [1] 292628 0
Safety (measured as number of adverse events associated with exercise training)
Timepoint [1] 292628 0
Mid Intervention (4 weeks) and post intervention (8 weeks)
Primary outcome [2] 292629 0
Adherence (measured as attendance and compliance to exercise training)
Timepoint [2] 292629 0
Mid Intervention (4 weeks) and post intervention (8 weeks)
Secondary outcome [1] 309370 0
VO2peak - measured during a maximal progressive exercise test on an electronically braked cycle ergometer via ergospirometery.
Timepoint [1] 309370 0
Mid Intervention (4 weeks) and post intervention (8 weeks)
Secondary outcome [2] 309371 0
Muscular strength - measured using an isometric mid-thigh pull apparatus. This method is a valid measure of global muscular strength and provides objective data on force and time variables.
Timepoint [2] 309371 0
Mid Intervention (4 weeks) and post intervention (8 weeks)
Secondary outcome [3] 309372 0
Physical Activity - measured using a combination of wrist-worn GENEActiv accelerometer and International Physical Activity Questionnaire (IPAQ).
Timepoint [3] 309372 0
Mid Intervention (4 weeks) and post intervention (8 weeks)
Secondary outcome [4] 309373 0
Quality of Life - measured using the Chronic Liver Disease Quality of Life tool (CLDQ).
Timepoint [4] 309373 0
Mid Intervention (4 weeks) and post intervention (8 weeks)
Secondary outcome [5] 309374 0
Systemic endothelial function - measured using flow-mediated dilation (FMD) of brachial artery via ultrasound technique.
Timepoint [5] 309374 0
Mid Intervention (4 weeks) and post intervention (8 weeks)
Secondary outcome [6] 309375 0
Autonomic Heart Function - measured using 5-minute supine heart rate variability technique.
Timepoint [6] 309375 0
Mid Intervention (4 weeks) and post intervention (8 weeks)
Secondary outcome [7] 309376 0
Six minute walk test (6MWT) - determined by the total distance walked during a six minute period on a 30 meter track.
Timepoint [7] 309376 0
Mid Intervention (4 weeks) and post intervention (8 weeks)
Secondary outcome [8] 367738 0
Ventilatory threshold - measured during a maximal progressive exercise test on an electronically braked cycle ergometer via ergospirometery.
Timepoint [8] 367738 0
Mid Intervention (4 weeks) and post intervention (8 weeks)

Eligibility
Key inclusion criteria
- Candidate for Liver Transplant - as per guidelines proposed by the Transplant Society of Australia and New Zealand for Organ Transplant from Decreased Donors
- Gender - males and females are eligible. The study will endeavor to recruit approximately equal numbers of males and females.
- Age - Individuals aged 18 to 69 years old are eligible. At the Princess Alexandra Hospital, patients are not eligible for a liver transplant following the age of 69 years old due to organ allocation policies.
- Ethnicity - All ethnic groups are eligible for the study. There is likely to be incidental recruitment of participants of Aboriginal or Torres Strait Islander ethnicity.
- Willingness to participate - patients must be willing to be randomized to either the exercise intervention or usual care groups and to adhere to the protocol that they have been assigned.
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients that have previously undergone a liver transplant
- On transplant listing for other organs
- Currently smoking
- Any abnormality during the cardiopulmonary exercise test that indicates that it would be considered unsafe to participate in an exercise training intervention
- Uncontrolled diabetes mellitus
- Orthopaedic and/or neurological limitation to exercise as assessed by the principal investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/08/2014
Actual
12/11/2014
Date of last participant enrolment
Anticipated
Actual
1/04/2016
Date of last data collection
Anticipated
Actual
29/04/2016
Sample size
Target
30
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3691 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 289589 0
University
Name [1] 289589 0
School of Human Movement Studies, The University of Queensland
Country [1] 289589 0
Australia
Primary sponsor type
Individual
Name
Mr Matthew Wallen
Address
Building 26, Blair Drive
The University of Queensland
St Lucia, 4072, QLD, AUS
Country
Australia
Secondary sponsor category [1] 288273 0
Hospital
Name [1] 288273 0
Princess Alexandra Hospital
Address [1] 288273 0
199 Ipswich Road
Woolloongabba, 4102, QLD, AUS
Country [1] 288273 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291324 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 291324 0
Princess Alexandra Hospital
Centres for Health Research
Level 7, Translational Research Institute
37 kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 291324 0
Australia
Date submitted for ethics approval [1] 291324 0
17/07/2014
Approval date [1] 291324 0
28/08/2014
Ethics approval number [1] 291324 0
EC00167

Summary
Brief summary
Prior to transplantation, patients with end stage liver failure experience marked declines in cardiorespiratory fitness and muscular strength compared to age matched healthy controls. This affects the patient’s ability to perform activities of daily living, which severely impacts upon health related quality of life. Emerging evidence suggests that a higher cardiorespiratory fitness prior to transplant surgery can result in higher post-operative survival rate. It has also been demonstrated that there is a decreased time in critical care following transplantation. Exercise training has demonstrated to be a safe and effective therapy for improving these physiological parameters, however evidence as to whether it is safe, feasible and efficacious in end stage liver disease patients requiring a liver transplantation is minimal and requires further investigation. Therefore, the aim of this study is to investigate the safety, adherence and efficacy of a 12-week exercise training program and exercise maintenance in patients awaiting a liver transplantation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49890 0
Mr Matthew Wallen
Address 49890 0
School of Human Movement Studies
Building 26, Blair Drive
The University of Queensland
St Lucia, 4072, QLD, AUS
Country 49890 0
Australia
Phone 49890 0
+614 1918 3401
Fax 49890 0
Email 49890 0
[email protected]
Contact person for public queries
Name 49891 0
Prof Jeff Coombes
Address 49891 0
School of Human Movement Studies
Building 26, Blair Drive
The University of Queensland
St Lucia, 4072, QLD, AUS
Country 49891 0
Australia
Phone 49891 0
(+61) 7 3365 6767
Fax 49891 0
Email 49891 0
[email protected]
Contact person for scientific queries
Name 49892 0
Prof Jeff Coombes
Address 49892 0
School of Human Movement Studies
Building 26, Blair Drive
The University of Queensland
St Lucia, 4072, QLD, AUS
Country 49892 0
Australia
Phone 49892 0
(+61) 7 3365 6767
Fax 49892 0
Email 49892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExercise Training Is Safe and Feasible in Patients Awaiting Liver Transplantation: A Pilot Randomized Controlled Trial.2019https://dx.doi.org/10.1002/lt.25616
N.B. These documents automatically identified may not have been verified by the study sponsor.