Wellness Program for Transplant Patients

(TWP Trial)

Overseen By Stefan Mustata, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Non-selective beta blockers

Disqualifiers: Refractory encephalopathy, unsafe environment, others

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

Compensation: Varies

Number of Visits: Unknown

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help liver and kidney transplant patients improve their overall health and quality of life before and after surgery. It involves a 12-week program called the Transplant Wellness Program, which includes exercise, nutrition, stress reduction, and sleep support. The goal is to enhance patients' physical and mental well-being while potentially reducing hospital visits and stays. Individuals on the waiting list for a kidney or liver transplant who have been approved to exercise might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity for patients to enhance their well-being and potentially improve transplant outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.

What prior data suggests that the Transplant Wellness Program is safe for transplant patients?

Research shows that exercise programs are generally safe for liver transplant patients. Studies on prehabilitation, or exercising before surgery, indicate it is safe and feasible for those awaiting a liver transplant. Patients can typically handle exercise without major issues.

For kidney transplant patients, a similar exercise and wellness program has been researched. Participants often feel less tired and more motivated to stay active, suggesting that the exercise component is well-tolerated.

In both liver and kidney transplant cases, the Transplant Wellness Program (TWP) supports patients with a combination of exercise, nutrition, stress reduction, and improved sleep. The goal is to enhance overall health and quality of life. Available data confirm that these wellness activities are safe for transplant patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional post-transplant care that mostly focuses on medical management, the Transplant Wellness Program (TWP) emphasizes a holistic approach to recovery for both liver and kidney transplant patients. Researchers are excited about this program because it integrates a 12-week exercise intervention tailored specifically to the needs of transplant patients, aiming to improve their quality of life (QOL) and functional fitness. For liver transplant patients, the program includes specialized assessments like the Chronic Liver Disease Questionnaire and the Liver Frailty Index, while kidney transplant patients benefit from the Kidney Disease Quality of Life-36 survey. By offering disease-specific exercise and wellness materials, TWP supports lasting behavioral change, potentially enhancing recovery and overall health outcomes beyond what standard medical care alone can achieve.

What evidence suggests that this trial's treatments could be effective for transplant patients?

The Transplant Wellness Program (TWP), provided to participants in this trial, effectively aids liver and kidney transplant patients in recovery. For those in the liver transplant arm, research has shown that exercise and wellness programs can enhance physical fitness and quality of life, with benefits linked to improved heart and lung function and increased physical stamina. Participants in the kidney transplant arm have also experienced benefits, such as improved endurance, heart health, and muscle strength. Additionally, combining exercise with healthy lifestyle changes can reduce tiredness and improve sleep for kidney transplant recipients. Overall, the TWP offers promising support for transplant patients seeking long-term health improvements. ^{1 2 3 6 7}

Who Is on the Research Team?

Stefan Mustata, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

The Transplant Wellness Program is for patients awaiting or having recently undergone kidney or liver transplant surgery. It aims to support their overall health and quality of life through a multiphase approach including exercise, nutrition, stress reduction, and sleep programs.

Inclusion Criteria

Able to provide written informed consent and understand study information in English

Have access to an internet connected device

I am on the waiting list for a kidney or liver transplant.

Exclusion Criteria

Not cleared for participation in the TWP by attending physician

I am unable to understand and give consent for treatment.

Unsafe environment for virtual participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in prehabilitation activities including exercise and wellness behavior change support before transplant surgery

12 weeks

Multiple visits (in-person or virtual)

Post-Transplant Rehabilitation

Participants continue with exercise and wellness behavior change support after transplant surgery

12 weeks

Multiple visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including functional fitness assessments and patient-reported outcomes

5 years

Annual assessments (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Transplant Wellness Program

Trial Overview This trial tests the TWP's effectiveness in improving physical fitness, reducing healthcare use, and enhancing mental well-being pre- and post-transplant. The program includes a 12-week exercise regimen complemented by wellness webinars, group coaching, and behavior change support.

How Is the Trial Designed?

Group I: Liver transplant arm Experimental Treatment 1 Intervention

Liver transplant patients will be assigned to the liver transplant arm and receive the standard 12-week exercise intervention in the TWP. Specific to the liver arm will be certain PROs and functional fitness measures. The Chronic Liver Disease Questionnaire (CLQD) measures health-related QOL in patients with advanced liver disease and has been previously used in patients awaiting transplant. Liver arm participants will also complete the Liver frailty index, which requires a timed 5 sit-to-stands in addition to the other measures collected for the Fried Frailty Index. Participants in this arm will receive liver-specific exercise and wellness materials to support their behaviour change.

Group II: Kidney transplant arm Experimental Treatment 1 Intervention

Kidney transplant patients will be assigned to the kidney transplant arm and receive the standard 12-week exercise intervention in the TWP. Specific to the kidney arm will be certain patient reported outcomes (PROs). The Kidney Disease Quality of Life-36 (KDQOL-36) is a short form survey widely used to measure patient-reported QOL in patients on dialysis and is a validated tool in kidney transplant patients. Participants in the kidney arm will also receive disease-specific exercise and wellness materials to support their behaviour change.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

Pharmaceutical manufacturers offer medication assistance programs that can provide essential medications at little or no cost to indigent patients, which can improve medication compliance and reduce financial burdens.

This article serves as a valuable resource for healthcare professionals, summarizing the available assistance programs for commonly prescribed medications in transplant patients, thereby increasing awareness and access to these vital resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assistance programs available for medications commonly used in transplant patients. Chisholm, MA., Tackett, KL., Kendrick, BD., et al.[2019]

The enhanced recovery program for renal transplant patients significantly reduced postoperative morphine requirements (median of 9.5 mg vs 47 mg in traditional recovery), indicating better pain management and potentially improved patient comfort.

Patients in the enhanced recovery group had a shorter hospital stay (median of 5 days for living donors and 5 days for deceased donors) compared to traditional recovery (7 days and 8.5 days, respectively), leading to substantial cost savings and high patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Better Journey for Patients, a Better Deal for the NHS: The Successful Implementation of an Enhanced Recovery Program After Renal Transplant Surgery. Halawa, A., Rowe, S., Roberts, F., et al.[2018]

A new patient education tool was developed to support solid organ transplant recipients after early hospital discharge, addressing the challenges of ensuring patient and family understanding of post-transplant care.

This tool aims to enhance self-care practices, promote wellness, and improve graft survival by providing essential information that can be easily reviewed during home care visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care guidelines: finding a common ground. Randolph, S., Scholz, K.[2019]

A pharmaceutical care program for liver transplant patients significantly improved compliance with immunosuppressive therapy, with an average dosing compliance of 90% in the intervention group compared to 81% in the control group, based on a study using medication event monitoring systems.

Patients receiving the pharmaceutical care were also more likely to achieve target blood levels of their medication, indicating that this intervention is effective and should be integrated into posttransplant care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a pharmaceutical care program on liver transplant patients' compliance with immunosuppressive medication: a prospective, randomized, controlled trial using electronic monitoring. Klein, A., Otto, G., Krämer, I.[2022]

A transplantation specialty pharmacy (TSP) program significantly increased patient satisfaction, with 84% of patients expressing satisfaction and 98% willing to recommend the program, while 96% of healthcare providers noted improved continuity of care.

The TSP program also demonstrated higher medication adherence among patients compared to historical controls, contributing to a positive financial margin of over $2 million in its first year, despite no significant differences in hospital readmissions or length of stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a transplantation specialty pharmacy program. Hlubocky, JM., Stuckey, LJ., Schuman, AD., et al.[2019]

Pharmacists play a crucial role in the care of solid organ transplant recipients, with their interventions leading to significant improvements in medication adherence, morbidity, and reduction of medication errors, based on a review of 12 studies involving 1837 patients.

Key pharmacist activities included medication counseling, reconciliation, and optimizing drug therapy, highlighting the importance of integrating clinical pharmacy services into transplant programs to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roles and Impacts of the Transplant Pharmacist: A Systematic Review. Sam, S., Guérin, A., Rieutord, A., et al.[2022]

Nutrition is crucial for the recovery and long-term health of transplant recipients, with different nutrient needs during the acute recovery phase focused on healing and the chronic maintenance phase aimed at preventing complications.

Individualized nutrition therapy is essential, as it should be tailored to address specific health issues like obesity, diabetes, and hypertension that may arise after transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet therapy for organ transplantation. A problem-based approach. Hasse, JM.[2008]

A medication assistance program with medication therapy management (MTM) significantly improved clinical outcomes for renal transplant recipients, including better control of hypertension, diabetes, and dyslipidemia, as well as a decrease in graft rejections over one year.

Participants in the program also experienced a notable increase in health-related quality of life (HQOL) after one year, indicating that the program not only enhanced medication access but also positively impacted patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a medication assistance program with medication therapy management on the health of renal transplant recipients. Chisholm, MA., Spivey, CA., Mulloy, LL.[2022]

In a study of 291 liver transplant recipients, those who received outpatient medication consultations from a clinical pharmacist had significantly fewer medication-related problems (MRPs) compared to those who did not, indicating the effectiveness of pharmacist involvement in post-transplant care.

Patients who received medication consultations used fewer unnecessary drugs (39.4% vs. 72.1%) and had lower rates of suboptimal therapy and underdosing, highlighting the importance of clinical pharmacists in improving medication management and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of medication-related problems in liver transplant recipients with and without an outpatient medication consultation by a clinical pharmacist: a cohort study. Mulder, MB., Doga, B., Borgsteede, SD., et al.[2022]

The Transplant-TAVIE intervention, a web-based program designed to improve medication adherence among kidney transplant patients, was found to be feasible and acceptable, with 54% of participants completing the sessions and high satisfaction rates reported.

Despite the intervention's positive reception, there were no significant differences in medication adherence or self-efficacy between the Transplant-TAVIE group and the control group using existing websites, indicating that while the program is promising, its impact on adherence may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Tailored Intervention to Support Optimal Medication Adherence Among Kidney Transplant Recipients: Pilot Parallel-Group Randomized Controlled Trial. Côté, J., Fortin, MC., Auger, P., et al.[2020]

Aetna has implemented a Disease Management (DM) program aimed at improving medication adherence among transplant patients, addressing the common issue of organ rejection due to non-compliance.

Early results suggest that this program is positively impacting patient outcomes by providing additional support for managing complex medication regimens and their side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New program applies principles of DM to transplant patients. [2004]

Implementing educational and support services can significantly reduce noncompliance in transplant recipients, leading to better health outcomes.

Choosing immunosuppression protocols with fewer side effects and medications enhances patient satisfaction and compliance, which is crucial for maintaining graft function and improving long-term quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of transplantation on quality of life. Galbraith, CA., Hathaway, D.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39449962/

An Exercise and Wellness Behavior Change Program for ... The TWP aims to support patients throughout the transplant journey through a multimodal and comprehensive exercise and wellness behavior change program.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11500225/

An Exercise and Wellness Behavior Change Program for ... The TWP aims to support patients throughout the transplant journey through a multimodal and comprehensive exercise and wellness behavior change program.

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/20543581241289196

An Exercise and Wellness Behavior Change Program for ... The TWP aims to support patients throughout the transplant journey through a multimodal and comprehensive exercise and wellness behavior change program.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1440244025001902

Physical activity and exercise performance in patients after ... A multimodal follow-up care program promoting physical activity improved markers of endurance, cardiovascular health, and muscular strength in kidney transplant ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925002098

Effect of Exercise or Combined Exercise and Diet ... Physical functioning and diet may be promising targets to improve sleep and reduce fatigue among kidney transplant recipients (KTRs). We investigated whether a ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04054323

The Efficacy of Physical Activity on Improving Health ... While physical activity (PA) interventions have been shown to be effective in reducing morbidity and mortality in other chronic diseases, no study has tested ...

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The effects of a physical exercise program in Chinese kidney ... Our results indicated that Chinese KTRs could benefit from the physical exercise program, showing less fatigue, more motivation to be active, a higher phase ...