Kidney Transplant
Conditions
Keywords
Physical Activity, Exercise Rehabilitation, Kidney Function, Employment, Kidney Transplant
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.
Interventions
BEHAVIORALExercise Rehabilitation
12 month personalized exercise rehabilitation in addition to standard clinical care
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Subclinical Atherosclerosis - PWV | 12 months | This will be assessed through measures of aortic pulse wave velocity (PWV) |
| 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. |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Rehabiliation 12 month personalized exercise rehabilitation in addition to standard clinical care
Exercise Rehabilitation: 12 month personalized exercise rehabilitation in addition to standard clinical care | 80 |
| Control Standard clinical care only | 33 |
| Total | 113 |
Baseline characteristics
| Characteristic | Exercise Rehabiliation | Total | Control |
|---|---|---|---|
| Age, Continuous | 47.29 years STANDARD_DEVIATION 11.56 | 45.24 years STANDARD_DEVIATION 11.61 | 43.18 years STANDARD_DEVIATION 11.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 54 Participants | 75 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 23 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 12 Participants | 2 Participants |
| Region of Enrollment United States | 80 participants | 113 participants | 33 participants |
| Sex: Female, Male Female | 32 Participants | 50 Participants | 18 Participants |
| Sex: Female, Male Male | 48 Participants | 63 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Employment Status
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.
Time frame: 12 months
Population: The count represents the number of participants who were unemployed at Baseline (excluding employed participants at baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exercise Rehabilitation | Employment Status | 21 Participants |
| Control | Employment Status | 2 Participants |
Secondary
Body Composition - Body Mass Index (BMI)
Body mass index is calculated as weight (kg) divided by height (m) squared
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Body Composition - Body Mass Index (BMI) | 35.90 kg/m^2 | Standard Deviation 8.12 |
| Control | Body Composition - Body Mass Index (BMI) | 35.12 kg/m^2 | Standard Deviation 10.03 |
Secondary
Body Composition - DEXA
Muscle mass will be assessed via Dual-energy X-ray absorptiometry (DEXA).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Body Composition - DEXA | 2858.10 Gram | Standard Deviation 678.12 |
| Control | Body Composition - DEXA | 2550.69 Gram | Standard Deviation 431.37 |
Secondary
Body Composition - Waist Circumference
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Body Composition - Waist Circumference | 45.50 Inches | Standard Deviation 7.33 |
| Control | Body Composition - Waist Circumference | 45.33 Inches | Standard Deviation 9.01 |
Secondary
Diastolic Blood Pressure
Blood pressure will be measured in the supine position (lying on back) in a dimly lit room after resting for fifteen minutes.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Diastolic Blood Pressure | 80.83 mmHg | Standard Deviation 10.71 |
| Control | Diastolic Blood Pressure | 82.46 mmHg | Standard Deviation 9.12 |
Secondary
Functional Capacity - 6MW
This will be assessed through the 6 minute walk test (6MW). The test measures the distance (in meters) patients can walk in 6 minutes.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Functional Capacity - 6MW | 418.41 Meters | Standard Deviation 111.65 |
| Control | Functional Capacity - 6MW | 405.95 Meters | Standard Deviation 95.79 |
Secondary
Functional Capacity - Strength (Away)
This will be assessed through measures of unilateral isometric strength utilizing Biodex. This measurement is for Away Peak 75-Peak Strength
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Functional Capacity - Strength (Away) | 108.02 Pounds | Standard Deviation 48.15 |
| Control | Functional Capacity - Strength (Away) | 100.01 Pounds | Standard Deviation 32.44 |
Secondary
Functional Capacity - Strength (Towards)
This will be assessed through measures of unilateral isometric strength utilizing Biodex. This measurement is for Towards Peak 75-Peak Strength
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Functional Capacity - Strength (Towards) | 44.53 Pounds | Standard Deviation 19.3 |
| Control | Functional Capacity - Strength (Towards) | 41.61 Pounds | Standard Deviation 17.62 |
Secondary
Metabolic State and Kidney Function - eGFR
Estimated glomerular filtration rate (eGFR) will be measured
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Metabolic State and Kidney Function - eGFR | 57.46 mL/min/1.73m^2 | Standard Deviation 20.91 |
| Control | Metabolic State and Kidney Function - eGFR | 62.48 mL/min/1.73m^2 | Standard Deviation 17.7 |
Secondary
Metabolic State and Kidney Function - Serum Creatinine (SCr)
Serum creatinine levels will be measured.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Metabolic State and Kidney Function - Serum Creatinine (SCr) | 1.46 mg/dL | Standard Deviation 0.5 |
| Control | Metabolic State and Kidney Function - Serum Creatinine (SCr) | 1.37 mg/dL | Standard Deviation 0.8 |
Secondary
Pain Intensity
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Pain Intensity | 1.98 units on a scale | Standard Deviation 2.59 |
| Control | Pain Intensity | 3.21 units on a scale | Standard Deviation 3.02 |
Secondary
Quality of Life and Perceived Health Status - PROMIS 10 Global Mental Health Score
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).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Quality of Life and Perceived Health Status - PROMIS 10 Global Mental Health Score | 53.11 T-score | Standard Deviation 7.95 |
| Control | Quality of Life and Perceived Health Status - PROMIS 10 Global Mental Health Score | 49.53 T-score | Standard Deviation 6.69 |
Secondary
Quality of Life and Perceived Health Status - PROMIS 10 Global Physical Health Score
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).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Quality of Life and Perceived Health Status - PROMIS 10 Global Physical Health Score | 51.58 T-score | Standard Deviation 8.3 |
| Control | Quality of Life and Perceived Health Status - PROMIS 10 Global Physical Health Score | 46.60 T-score | Standard Deviation 8.24 |
Secondary
Quality of Life and Perceived Health Status - PROMIS 29 Physical Function Score
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).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Quality of Life and Perceived Health Status - PROMIS 29 Physical Function Score | 48.89 T-score | Standard Deviation 8.64 |
| Control | Quality of Life and Perceived Health Status - PROMIS 29 Physical Function Score | 46.45 T-score | Standard Deviation 10.12 |
Secondary
Regular Physical Activity Using Accelerometers
Physical activity is assessed through accelerometers which give scores that are measured in m/s\^2
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Regular Physical Activity Using Accelerometers | 16.46 m/s^2 | Standard Deviation 13.54 |
| Control | Regular Physical Activity Using Accelerometers | 11.75 m/s^2 | Standard Deviation 9.17 |
Secondary
Subclinical Atherosclerosis - IMT
This will be assessed through measures of carotid intima-media thickness (IMT)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Subclinical Atherosclerosis - IMT | 0.58 millimeters | Standard Deviation 0.12 |
| Control | Subclinical Atherosclerosis - IMT | 0.57 millimeters | Standard Deviation 0.12 |
Secondary
Subclinical Atherosclerosis - PWV
This will be assessed through measures of aortic pulse wave velocity (PWV)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Subclinical Atherosclerosis - PWV | 7.16 meters/second | Standard Deviation 2.31 |
| Control | Subclinical Atherosclerosis - PWV | 6.06 meters/second | Standard Deviation 1.96 |
Secondary
Systolic Blood Pressure
Blood pressure will be measured in the supine position (lying on back) in a dimly lit room after resting for fifteen minutes.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Rehabilitation | Systolic Blood Pressure | 132.92 mmHg | Standard Deviation 15.69 |
| Control | Systolic Blood Pressure | 129.71 mmHg | Standard Deviation 17.22 |