Online Prehabilitation for Liver Cirrhosis (OPAL Trial)

N/A

Recruiting

Led By Puneeta Tandon

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post-study completion

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess if an online prehab program helps improve physical function for patients waiting for liver transplants. It will compare results to usual care.

Who is the study for?

This trial is for adults over 18 with liver cirrhosis who are somewhat frail or very frail, likely to be listed for a liver transplant, and can speak English or French. They must have internet access and an online device. It's not for those robust in health, expecting a living donor transplant soon, with high MELD-Na scores (>26), unable to consent, with less than 6 months to live, unsafe conditions for virtual participation or specific medical exclusions.

What is being tested?

The study tests if a 12-week online program focused on behavior, nutrition, and exercise (prehabilitation) can improve physical function in patients waiting for liver transplants compared to usual care. Over four years at five Canadian centers, participants will be randomly assigned to the prehabilitation group or usual care group.

What are the potential side effects?

Since this intervention involves non-invasive behavioral therapy and exercise programs delivered online rather than medication or surgery there may be minimal side effects such as muscle soreness from new exercises; however specific side effects are not detailed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post-study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post-study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in 6-item COM-B scale over time during intervention

Change in covert hepatic encephalopathy from baseline

Change in distance in the 6 minute walk test from baseline

+4 more

Other study objectives

Adverse events

Change in sarcopenia from baseline

Changes in functional status from baseline

+19 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prehabilitation GroupExperimental Treatment1 Intervention

The prehabilitation group will be provided with access to the online digital web platform which contains the weekly acceptance and commitment therapy based education videos, nutrition intervention, and exercise intervention.

Group II: Usual CareActive Control1 Intervention

This group will receive standard care for LT candidates with cirrhosis and will be provided with standard online exercise, nutrition, and behavioural resources. Control participants will not receive access to the online digital platform.

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