Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial (RCT) will examine the effect of a novel 12 month personalized exercise rehabilitation program compared to standard care following kidney transplantation. Return to work or find work rates, markers of subclinical atherosclerosis, functional capacity, body composition, quality of life, kidney function, and adherence to exercise will be measured. The investigators' primary hypothesis is that a 12 month exercise rehabilitation program will increase the return to work or find work rate in kidney transplant recipients. The investigators additionally hypothesize that a 12 month exercise rehabilitation program will prevent a decline in subclinical atherosclerosis, increase functional capacity, and increase lean muscle mass.

Detailed Description
-----------------
The proposed study, data collection, and intervention will be performed in the Integrative Physiology Laboratory at the University of Illinois at Chicago. Blood samples will be collected in the Transplant Clinic at the University of Illinois at Chicago. The study will use a two-arm RCT design to examine the effects of personalized exercise rehabilitation versus standard clinical care in kidney transplant (KT) recipients. The primary outcome will be patient return to work/find work rates. Secondary outcomes will include physical and vascular function, body composition, perceived quality of life, kidney function and blood lipid markers, and adherence. 120 kidney transplant recipients will be randomized 2:1 into either an exercise rehabilitation program or a control group, which involves standard clinical care only. Randomization will be done after obtaining informed consent and baseline testing, utilizing a computerized randomization program as a way to prevent potential selection bias. The exercise rehabilitation arm includes low intensity, personalized resistance trainings two times per week for a 12 month period in addition to standard clinical care (including regular check-ups and blood work as recommended by their post-transplant physician). The control group will continue standard care as advised by their post-transplant medical team with no additional intervention. The investigator will collect data on employment status, and all physiological and psychological data at baseline (before intervention), during (6 months), and immediately after the intervention (12 months). Adherence will be monitored throughout the entirety of the study by recording study visits as well as having the exercise trainers keep record of the patient's attendance in the exercise arm. A 2 X 3 (condition X time) mixed factor, analysis of variance with intent-to-treat principles will be utilized for testing the effect of the intervention on the outcome variables. The investigators' primary hypothesis is that a 12 month exercise rehabilitation program will increase the return to work/find work rate in kidney transplant recipients. It is additionally hypothesize that a 12 month exercise rehabilitation program will prevent a decline in subclinical atherosclerosis, increase functional capacity, and increase lean muscle mass. Outcome measures for subclinical atherosclerosis include aortic pulse wave velocity (PWV), carotid intima-media thickness (IMT), endothelial function and carotid arterial stiffness. The outcome measures for functional capacity include the 6 minute walk test (6MW), unilateral isometric strength test, and free-living accelerometry. Fat and lean muscle mass will be assessed via Dual-energy X-ray absorptiometry (DXA). Quality of life and perceptions of pain will be assessed utilizing the Patient Reported Outcomes Measurement Information System (PROMIS) Global health and PROMIS 29 v 2 questionnaires. Additionally, fasting blood lipid profile, inflammatory markers, and markers of kidney function including glomerular filtration rate (GFR) and creatinine levels will be measured.

Official Title
-----------------
Randomized Case-Control Trial About the Impact of Targeted Physical Activity and Diet Modification on Kidney Transplant Recipients' Outcome

Conditions
-----------------
Kidney Transplant

Intervention / Treatment
-----------------
* Behavioral: Exercise Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 2 moths post-transplant must have adequate cognitive ability to complete questionnaires, give consent for the study and follow the physical instructions Exclusion Criteria: any other organ besides kidney or kidney/pancreas mix any surgery or procedure to assist in weight loss (ie bariatric surgery) non-ambulatory or significant orthopedic problems cardiac/pulmonary disease that contraindicates the physical training any contraindication to exercise testing per the American Heart Association if the patient is unable to comply with the training program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Rehabiliation<br>12 month personalized exercise rehabilitation in addition to standard clinical care | Behavioral: Exercise Rehabilitation<br>* 12 month personalized exercise rehabilitation in addition to standard clinical care<br>|
| No Intervention: Control<br>Standard clinical care only | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work or find work rate | This will be assessed through verbal questioning on current employment status | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subclinical atherosclerosis | This will be assessed through measures of aortic pulse wave velocity (PWV) | 12 months | 
| Functional capacity | This will be assessed through the 6 minute walk test (6MW) | 12 months | 
| Body Composition | Fat and lean muscle mass will be assessed via Dual-energy X-ray absorptiometry (DXA). | 12 months | 
| Metabolic state and Kidney Function | Fasting blood lipid profile will be measured | 12 months | 
| Quality of life and perceived health status | The Patient Reported Outcomes Measurement Information System (PROMIS) v.1.1 - Global Health short form will be administered to all patients to assess perception of general health. | 12 months | 
| Subclinical atherosclerosis | This will be assessed through measures of carotid intima-media thickness (IMT) | 12 months | 
| Subclinical atherosclerosis | This will be assessed through measures of endothelial function and carotid arterial stiffness via flow mediated dilation (FMD). | 12 months | 
| Functional capacity | This will be assessed through measures of unilateral isometric strength utilizing Biodex. | 12 months | 
| Regular physical activity | This will be assessed through free-living accelerometry | 12 months | 
| Inflammatory marker | C-reactive protein(CRP) | 12 months | 
| Metabolic state and Kidney Function | Glomerular filtration rate (GFR) will be measured | 12 months | 
| Metabolic state and Kidney Function | Creatinine levels will be measured. | 12 months | 
| Quality of life and perceived health status | The PROMIS 29 Profile v2.0 will be administered to all patients to assess perception of general health. | 12 months | 
| Pro-inflammatory cytokines | IL-6 will be measured. | 12 month | 
| Pro-inflammatory cytokines | IL-1 will be measured. | 12 month | 
| Pro-inflammatory cytokines | TNF-alpha will be measured. | 12 month | 
| Pro-inflammatory cytokines | Homocysteine will be measured. | 12 month | 
| Pro-inflammatory cytokines | Adiponectin will be measured. | 12 month | 
| Pro-inflammatory cytokines | Leptin will be measured. | 12 month | 
| Pro-inflammatory cytokines | Resistin will be measured | 12 month | 
| Pro-regenerative cytokines | TGF-beta will be measured | 12 month | 
| Pro-regenerative cytokines | IL-10 will be measured | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Activity, Exercise Rehabilitation, Kidney Function, Employment, Kidney Transplant