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Behavioural Intervention
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
OPAL Trial 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.Check my eligibility
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.See study design
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.
OPAL Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
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 moreOther outcome measures
Adverse events
Change in sarcopenia from baseline
Changes in functional status from baseline
+19 moreOPAL 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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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,000 Total Patients Enrolled
9 Trials studying Liver Cirrhosis
5,649 Patients Enrolled for Liver Cirrhosis
Puneeta TandonPrincipal InvestigatorUniversity of Alberta
3 Previous Clinical Trials
133 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and have been diagnosed with cirrhosis.I have had a recent variceal bleed or have varices without proper prevention.I need a transplant due to bile duct cancer.I am unable to understand and give consent for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Prehabilitation Group
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what capacity is this experimentation enrolling participants?
"Indeed, according to clinicaltrials.gov this investigation is currently hunting for individuals. This trial was announced on July 12th 2023 and the data was most recently modified on August 21st 2023. The study requires 177 participants to be found at 1 site of recruitment."
Answered by AI
Are there any open participation opportunities for this research endeavor?
"Affirmative. According to the clinicaltrials.gov records, this medical investigation has been recruiting patients since July 12th 2023 and was last modified on August 21st 2023. The 177 intended participants must come from one particular location."
Answered by AI
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