None listed
Conditions
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.
Interventions
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 endothel
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).
Sponsors
Mr Matthew Wallen
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Healthy volunteers
No
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.
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
Outcome results
None listed