Online Prehabilitation for Patients Awaiting Liver Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
Physical frailty is common in patients awaiting liver transplantation and has been associated with poor health outcomes. There is promising data from small studies showing that behavioural, nutrition, exercise therapy (prehabilitation) improves physical function in patients while they are waiting for a liver transplant.
The proposed trial will assess if a 12-week online prehabilitation program improves physical function in patients listed for liver transplantation. Over 4 years, 177 patients will be recruited from 6 transplant centres across Canada and will be randomized to receive either the online prehabilitation program or usual care.
The primary outcome of physical function will be evaluated using the FTSST at baseline and 12 weeks (or last timepoint before transplant) assessed virtually or in-person. Secondary outcomes include liver specific physical frailty, aerobic fitness, health-related quality of life (QoL), participant experience and acceptability. Exploratory outcomes include other virtual and in-person physical function measures, covert hepatic encephalopathy (CHE), sarcopenia, malnutrition, adherence, behaviour factors, clinical and post-transplant outcomes. Results will be compared between the intervention and usual care groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Listed for living related donor transplantation with expected time on the wait list <12 weeks, or model for end-stage liver disease (MELD-Na) Score >26 (Justification: time to transplant is very short)
Robust status on frailty testing (LFI 0-3.1) (Justification: unlikely to see benefit)
Unable to provide informed consent
Presence of a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation
Trial design
Design model
Parallel
Treatments tested in this trial
Prehabilitation Programming
Behavioral12-weeks of online prehabilitation programming including: 1.12 weeks of nutrition programming focused on achieving a guideline- based protein intake of 1.2-1.5 g/kg/day. Participants will participate in a dietitian assessment and 0-2 dietitian follow-ups stratified by risk and 5 virtual group nutrition classes. Participants will be provided with a whey protein powder supplement - dosing stratified by risk. 2.10 weeks of exercise programming focused on completion of 3 full- body resistance/aerobic exercise sessions weekly (1 or 2 virtual group classes as per patient preference + 1 or 2 pre-recorded home exercise videos). 3.12 weeks of acceptance and commitment therapy based educational videos and online activities focused on reducing stress and anxiety and improving motivation and adherence.
Treatment groups
177 Participants
are divided into 2 treatment groupsGroup A: Prehabilitation GroupExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in time to do 5-sit-to-stands from baseline
A time to complete 5 chair stands of \>15 seconds predicts morbidity and mortality in patients with cirrhosis. This test shows promise as a frailty measure that could be evaluated over a virtual platform
Time frame
Week 02
Change in time to do 5-sit-to-stands from baseline
A time to complete 5 chair stands of \>15 seconds predicts morbidity and mortality in patients with cirrhosis. This test shows promise as a frailty measure that could be evaluated over a virtual platform
Time frame
Week 12Secondary outcomes
1
Change in liver frailty index from baseline
Liver frailty will be assessed with a cirrhosis-specific tool. The in-person LFI which includes grip strength, chair stand and balance testing, or the virtual TeLeFI which includes virtual FTSST, three stance balance test, and selected questions from validated surveys. The LFI is an independent predictor of waitlist mortality and hospitalization. The LFI score can be calculated using an online calculator (available at http://liverfrailtyindex.ucsf.edu), with patient physical frailty categorized as robust, prefrail, and frail according to their index (index \< 3.2, robust; 3.2-4.5, prefrail; and \>4.5, frail). Higher scores mean a worse outcome.
Time frame
Week 02
Change in liver frailty index from baseline
Liver frailty will be assessed with a cirrhosis-specific tool. The in-person LFI which includes grip strength, chair stand and balance testing, or the virtual TeLeFI which includes virtual FTSST, three stance balance test, and selected questions from validated surveys. The LFI is an independent predictor of waitlist mortality and hospitalization. The LFI score can be calculated using an online calculator (available at http://liverfrailtyindex.ucsf.edu), with patient physical frailty categorized as robust, prefrail, and frail according to their index (index \< 3.2, robust; 3.2-4.5, prefrail; and \>4.5, frail). Higher scores mean a worse outcome.
Time frame
Week 123
Changes in virtual physical function testing over time (2-min step test)
The 2-min step test is used to assess aerobic endurance and functional fitness. The subject marches in place for two minutes. The literature supports good correlation of this virtual measure when compared to in-person testing
Time frame
Week 04
Changes in virtual physical function testing over time (2-min step test)
The 2-min step test is used to assess aerobic endurance and functional fitness. The subject marches in place for two minutes. The literature supports good correlation of this virtual measure when compared to in-person testing
Time frame
Week 12Other outcomes
1
Change in time to do 5-sit-to-stands from baseline
A time to complete 5 chair stands of \>15 seconds predicts morbidity and mortality in patients with cirrhosis. This test shows promise as a frailty measure that could be evaluated over a virtual platform Completed at week 8 to account for the possibility of transplantation or loss-to-follow-up before the end of the 12 weeks.
Time frame
Week 82
Change in sarcopenia from baseline
Calf circumference is a simple measure for appendicular skeletal muscle and predicting sarcopenia
Time frame
Week 03
Change in sarcopenia from baseline
Calf circumference is a simple measure for appendicular skeletal muscle and predicting sarcopenia
Time frame
Week 124
Change in distance in the 6 minute walk test from baseline
6MWT distance correlates with waitlist mortality and QoL and is recommended by the American Society of Transplantation. It is associated with protein intake, activity level and physical function/ frailty.
Time frame
Week 0Sponsors and contacts
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Source ClinicalTrials.gov