The primary objective of this study is to assess the individual patients* response to an exercise program on aerobic capacity at six weeks by measuring the VO2 at the VAT and VO2peak before and after a homebased bimodal lifestyle program in non-fit…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter/endpoint is the progression in aerobic capacity after
6 weeks. Hereto, before and after the first training period a CPET will
performed to determine the difference in VO2 at the VAT and VO2peak in
ml/kg/min.
Secondary outcome
A secondary parameter/endpoint of this study is the progression in aerobic
capacity after the second training period, and six weeks after termination of
the program. Hereto, after 12 and 18 weeks another CPET will be performed.
Other secondary parameters/endpoints are the evaluation of differences in
sarcopenia, anthropometry, functional mobility, quality of life, perceived
fatigue, incidence of hepatic encephalopathy, number of unplanned hospital
admissions, change in liver frailty index score and change in microbiome
composition at six, 12 and 18 weeks, or until transplantation. Furthermore,
postoperative outcomes up to twelve months post-OLT will be collected.
Background summary
Patients with liver cirrhosis who are on the waiting list for orthotopic liver
transplantation (OLT) encounter all key components of physical frailty, i.e.,
decreased functional capacity, impaired aerobic capacity and sarcopenia, which
all lead to fatigue, diminished quality of life, increased hospitalization and
pre- and post-transplantation morbidity and mortality. An exercise program in
combination with nutritional support has proven to improve all key components
of physical frailty and quality of life in various surgical patient
populations. Although small studies have demonstrated similar positive effects
of exercise training in patients on the waiting list for OLT, to date no large
studies supported the effects of exercise training and nutritional support on
(the longevity of) the increase in aerobic capacity in OLT patients.
Study objective
The primary objective of this study is to assess the individual patients*
response to an exercise program on aerobic capacity at six weeks by measuring
the VO2 at the VAT and VO2peak before and after a homebased bimodal lifestyle
program in non-fit patients with liver cirrhosis awaiting OLT.
Secondary objectives are to assess individual differences in sarcopenia,
anthropometry, functional mobility, quality of life, perceived fatigue,
incidence of hepatic encephalopathy, number of unplanned hospital admissions,
change in liver frailty index score and change in microbiome composition at
six, 12, and 18 weeks. The aerobic capacity will also be re-evaluated at 12 and
18 weeks. Furthermore, the feasibility of a semi-supervised home-based bimodal
lifestyle program in patients with liver cirrhosis awaiting OLT will be
evaluated.
Study design
This study is an investigator-initiated, single center, single arm, prospective
clinical trial. It will take place at the University Medical Center Groningen,
the Netherlands. Eligible patients will participate in the bimodal lifestyle
program, which comprises two home-based training periods of six-weeks each (12
weeks training in total, or until transplantation). After 18 weeks (i.e., six
weeks after termination of the program) a final assessment will take place to
evaluate the longevity of the expected effects of the lifestyle program on
predefined study outcomes.
Intervention
Patients will participate in a home-based bimodal lifestyle program. The
program comprises semi-supervised high intensity interval and endurance
training on an advanced cycle ergometer (Lode Corival Home+, Lode BV,
Groningen, The Netherlands), combined with nutritional support consisting of
protein, vitamin and mineral supplementation. Moreover, to improve functional
mobility and muscle function patients will perform peripheral resistance
training of the large muscle groups of the upper and lower extremities.
Finally, to improve respiratory performance after surgery and potentially
reduce pulmonary complications, patients will perform breathing exercises. The
program will be patient personalized and compromises three training sessions
per week. The cycle ergometer used for this program will upload training
results to an online platform, enabling remote monitoring of patients*
adherence and training progress. Furthermore, a community physical therapist
will visit the patient at least weekly to monitor progress and to optimize the
training intensity.
Study burden and risks
Because the exercise program is situated at home (both the cycle ergometer as
the community physiotherapist will come to the patient) the investigators make
things as accessible as possible for the patient to participate. Supervision by
the physiotherapist during the training sessions is arranged three times in the
first week and at least once a week thereafter. At the start of the program a
CPET with continuous ECG monitoring will be executed under guidance of trained
employees to assess baseline cardiorespiratory fitness, as well as to rule out
strain related cardiac ischemia and other contraindications for physical
exercise training during the consecutive exercise program. Hence, patient*s
safety in the exercise program is guaranteed.
Hanzeplein 1
GRONINGEN 9700RB
NL
Hanzeplein 1
GRONINGEN 9700RB
NL
Listed location countries
Age
Inclusion criteria
• Diagnosed with end-stage liver disease / liver cirrhosis (regardless of
etiology);
• On the waiting list for OLT;
• VO2 at the VAT <=13 ml/kg/min and/or VO2peak <=18 ml/kg/min;
• Speaks the Dutch language;
• Aged at least 18 years;
• Understands the purpose of the study and has given written informed
consent to participate in the
study.
Exclusion criteria
• Experienced a MACE (e.g., myocardial infarction) in the past six months;
• Experienced a cerebrovascular incident in the past six months;
• Medical history of an uncontrolled heart rhythm disorder;
• Hepatic encephalopathy grade 3 or 4;
• Acute liver failure;
• Acute on chronic liver failure;
• Hospitalization at start of the study;
• Non-treated esophageal varices (i.e., variceal eradication endoscopy and/or
adequately dosed NSBB);
• Not capable of cycling on a cycle ergometer
• No available community physical therapist in the living area of the
patient.
Patients refusing or unable to sign informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83612.042.23 |