Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients

Not Applicable

Completed

Conditions: Kidney Transplant

Interventions: Behavioral: Exercise Rehabilitation

Registration Number: NCT02409901

Lead Sponsor: University of Illinois at Chicago

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 135

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Rehabiliation	Exercise Rehabilitation	12 month personalized exercise rehabilitation in addition to standard clinical care

Primary Outcome Measures

Name	Time	Method
Employment Status	12 months	This will be assessed through verbal questioning on the current employment status of each participant. Overall number of participants only includes participants who were unemployed at baseline.

Secondary Outcome Measures

Name	Time	Method
Subclinical Atherosclerosis - PWV	12 months	This will be assessed through measures of aortic pulse wave velocity (PWV)
Functional Capacity - 6MW	12 months	This will be assessed through the 6 minute walk test (6MW). The test measures the distance (in meters) patients can walk in 6 minutes.
Body Composition - DEXA	12 months	Muscle mass will be assessed via Dual-energy X-ray absorptiometry (DEXA).
Metabolic State and Kidney Function - eGFR	12 months	Estimated glomerular filtration rate (eGFR) will be measured
Quality of Life and Perceived Health Status - PROMIS 10 Global Physical Health Score	12 months	The Patient Reported Outcomes Measurement Information System (PROMIS) 10 - Global Physical Health short form will be administered to all patients to assess their perception of physical health at 12 months. The scale includes a list of questions that patients rate from 1 (poor) which is a minimum value on the scale to 5 (excellent) which is the maximum value on the scale. A higher score indicates a better quality of life. The raw scores from the questions are converted into standardized t-scores. In the U.S. general population, the t-score has a mean of 50 and a standard deviation of 10. A t-score higher than 50 indicates a better quality of life compared to the general population. The cut points for the t-score are as follows: above 58 (excellent), 50 to 58 (very good), 42 to 50 (good), 35 to 42 (fair), below 35 (poor).
Subclinical Atherosclerosis - IMT	12 months	This will be assessed through measures of carotid intima-media thickness (IMT)
Functional Capacity - Strength (Away)	12 months	This will be assessed through measures of unilateral isometric strength utilizing Biodex. This measurement is for Away Peak 75-Peak Strength
Regular Physical Activity Using Accelerometers	12 months	Physical activity is assessed through accelerometers which give scores that are measured in m/s\^2
Metabolic State and Kidney Function - Serum Creatinine (SCr)	12 months	Serum creatinine levels will be measured.
Quality of Life and Perceived Health Status - PROMIS 29 Physical Function Score	12 months	The Patient Reported Outcomes Measurement Information System (PROMIS) 29 form will be administered to all patients to assess their perception of their physical function12 months. The scale includes a list of questions that patients rate from 1 (poor) which is a minimum value on the scale to 5 (excellent) which is the maximum value on the scale. A higher score indicates a better quality of life. The raw scores from the questions are converted into standardized t-scores. In the U.S. general population, the t-score has a mean of 50 and a standard deviation of 10. A t-score higher than 50 indicates a better quality of life compared to the general population. The cut points for the t-score are as follows: above 45 (within normal limits), 45 to 40 (mild), 30 to 40 (moderate), below 30 (severe).
Quality of Life and Perceived Health Status - PROMIS 10 Global Mental Health Score	12 months	The Patient Reported Outcomes Measurement Information System (PROMIS) 10 - Global Mental Health short form will be administered to all patients to assess their perception of their mental health at 12 months. The scale includes a list of questions that patients rate from 1 (poor) which is a minimum value on the scale to 5 (excellent) which is the maximum value on the scale. A higher score indicates a better quality of life. The raw scores from the questions are converted into standardized t-scores. In the U.S. general population, the t-score has a mean of 50 and a standard deviation of 10. A t-score higher than 50 indicates a better quality of life compared to the general population. The cut points for the t-score are as follows: above 56 (excellent), 48 to 56 (very good), 40 to 48 (good), 29 to 40 (fair), below 29 (poor).
Functional Capacity - Strength (Towards)	12 months	This will be assessed through measures of unilateral isometric strength utilizing Biodex. This measurement is for Towards Peak 75-Peak Strength
Pain Intensity	12 months	Pain intensity is measured using PROMIS 29 scale. The scale includes a pain intensity question that patients rate from 1 (no pain) to 10 (extreme pain). A higher score indicates higher pain level.
Body Composition - Waist Circumference	12 months	Waist circumference will be measured at the narrowest part of the torso (above the umbilicus and below xiphoid process) in the standing position using a tape measure
Body Composition - Body Mass Index (BMI)	12 months	Body mass index is calculated as weight (kg) divided by height (m) squared
Systolic Blood Pressure	12 months	Blood pressure will be measured in the supine position (lying on back) in a dimly lit room after resting for fifteen minutes.
Diastolic Blood Pressure	12 months	Blood pressure will be measured in the supine position (lying on back) in a dimly lit room after resting for fifteen minutes.