The primary objective is to determine the feasibility of a semi-supervised homebased prehabilitation program for patients to be waitlisted for LT. The secondary objectives are to assess the effectiveness of this program and possible improvements of…
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 feasibility of the prehabilitation
program (program satisfaction, compliance, and percentage of patients willing
to participate in the prehabilitation program).
Secondary outcome
-Physical outcomes (functional capacity, aerobic capacity, daily physical
acitvity levels, hand grip strength, and quadriceps strength)
-Nutritional outcomes (nutritional status, body composition)
-Psychosocial outcomes (health status, anxiety and depression, self-efficacy)
-Substance abuse (smoking, alcohol consumption)
-Post operative outcomes (length of hospital stay, complications in first 30
days, readmission rate in first 30 days)
Background summary
Patients who qualify for liver transplantation (LT) are mostly frail due to
their underlying liver disease. Frailty is comprised by a decreased functional
capacity, impaired aerobic capacity, and sarcopenia. It is well known that
frailty leads to both increased pre- and post-transplantation morbidity as well
as mortality. For various surgical populations prehabilitation was demonstrated
to be feasible, effective, and to improve surgical outcomes. Few studies on
this subject have been conducted in the patient population awaiting liver
transplantation.
Study objective
The primary objective is to determine the feasibility of a semi-supervised
homebased prehabilitation program for patients to be waitlisted for LT. The
secondary objectives are to assess the effectiveness of this program and
possible improvements of surgical outcomes (e.g. less complications, faster
recovery, and shorter length of hospital stay).
Study design
This is a single-centre, single arm, prospective cohort study.
Intervention
Patients will participate in an eight-week semi-supervised home based
prehabilitation program. This program consists of physical exercise,
nutritional support provided by a dietician, smoking cessation, and
psychological counselling. The program will be personalized and consists of two
training sessions per week. Through a digital *Oefenportaal* platform the
physical therapist will supervise the exercises and monitor patients* adherence
to the program.
Study burden and risks
Patients will participate in an eight-week prehabilitation program prior to
anticipated LT. The prehabilitation sessions take approximately 3-5 hours per
week. In order to lower the burden for patients the majority of the program
takes place at home using digital tools. During the first week patients are
seen at the Erasmus MC for an intake (about 60 minutes). All study appointments
will be combined with regular appointments for screening if possible.
Furthermore, patients are expected on-site at the start and after completion of
the prehabilitation program to undergo measurements (90 minutes). Also, they
have to complete questionnaires at home three times total (two times 20
minutes, one time 10 minutes).
Since the prehabilitation program is based on existing care, we expect minimal
risks for the patients. Participants are anticipated to benefit from the
prehabilitation program considering a better physical fitness and a behavioural
change towards a healthier lifestyle.
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Anticipated waitlisting for liver transplantation
Exclusion criteria
1. Patients with severe physical or psychological comorbidities that limit
participation in the prehabilitation program
2. Acute or acute-on-chronic liver failure
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 | NL85306.078.23 |