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Behavioural Intervention

Kidney transplant arm for Transplant (TWP Trial)

N/A
Recruiting
Led By Stefan Mustata, MD
Research Sponsored by University of Calgary
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 study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention
Awards & highlights

TWP Trial Summary

"This trial focuses on the Transplant Wellness Program (TWP) which aims to support transplant patients through exercise and behavior change support before and after surgery. The program includes components like nutrition, stress reduction,

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this program focuses on wellness activities like exercise and stress management rather than medication or medical procedures, side effects are minimal but may include typical reactions to new exercise routines such as muscle soreness.

TWP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Generic self-reported quality of life
Kidney disease quality of life.
Liver disease quality of life
+1 more
Secondary outcome measures
Aerobic Endurance
Balance
Frailty
+9 more

TWP Trial Design

2Treatment groups
Experimental Treatment
Group I: Liver transplant armExperimental Treatment1 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 armExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
792 Previous Clinical Trials
868,734 Total Patients Enrolled
Stefan Mustata, MDPrincipal InvestigatorUniversity of Calgary

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this research investigation?

"Affirmative. The details on clinicaltrials.gov indicate that this investigation is actively seeking suitable individuals. This research initiative was initially disclosed on November 16th, 2023, with the latest revision dated April 11th, 2024. The study aims to recruit a total of 420 participants at one designated site."

Answered by AI

Are there still opportunities for individuals to participate in this ongoing medical research study?

"Per clinicaltrials.gov, this research endeavor is presently enrolling participants. The trial was first listed on 11/16/2023 and last modified on 4/11/2024."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Transplant Wellness Program
Stefan Mustata 2023. "Transplant Wellness Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06367244.
~280 spots leftby Nov 2033
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