Recovery Enhancement Program for Living Organ Donors

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Mobility issues, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to test if using these living donor-specific pre-transplant resources would lead to a better and faster recovery post-transplant.

Research Team

Guiliano Testa, MD

Principal Investigator

Simmons Transplant Institute, Baylor University Medical Center

Eligibility Criteria

This trial is for adults over 18 who are approved to be evaluated as living liver or kidney donors. They must be cleared by a doctor to exercise, willing to follow the study's rules including an exercise plan and visits, and not have any health issues that prevent walking alone. Pregnant or breastfeeding individuals cannot participate.

Inclusion Criteria

Subjects who have given IRB-approved written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

I am approved to be a living liver or kidney donor.

Cleared by a physician to participate in an exercise program

Exclusion Criteria

You are pregnant or currently breastfeeding.

I cannot walk by myself due to a health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants undergo at least 4-6 weeks of physical and relaxation skills training pre-transplant

4-6 weeks

Weekly visits (in-person or virtual)

Intra-operative

Participants receive anesthesia and undergo surgery

1 day

1 visit (in-person)

Post-operative

Participants receive pain management and nutritional support post-surgery

5-14 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including return to daily activities and emotional stress assessment

12 months

Monthly visits (in-person or virtual)

Treatment Details

Interventions

• Recovery Enhancement Program

Trial Overview The study is testing a Recovery Enhancement Program designed specifically for living organ donors. It aims to see if using pre-transplant resources helps achieve better and quicker recovery after donating an organ.

Participant Groups

Group I: Living Liver donor Active Control 1 Intervention

Recovery enhancement program: 1. At least 6 weeks of physical and relaxation skills training pre-transplant. 2. Taking nutritional drink for 5 days before and after the surgery. 3. Opioid sparing pain management.

Group II: Living Kidney donor (Control) Active Control 1 Intervention

1. Subjects maintain the same lifestyle without practicing physical training, relaxation skills or nutritional drink before and after the surgery. 2. To control post-op pain, subject will use medication per standard of care, including PCA pump.

Group III: Living Kidney donor Active Control 1 Intervention

Recovery Enhancement Program 1. At least 4 weeks of physical and relaxation skills training pre-transplant. 2. Taking nutritional drink for 5 days before and after the surgery. 3. Opioid sparing pain management.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+