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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Rehabilitation | Experimental | 12 month personalized exercise rehabilitation in addition to standard clinical care |
|
| Control | No Intervention | Standard clinical care only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Rehabilitation | Behavioral | 12 month personalized exercise rehabilitation in addition to standard clinical care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subclinical Atherosclerosis - PWV | This will be assessed through measures of aortic pulse wave velocity (PWV) | 12 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33733479 | Derived | Kastelz A, Fernhall B, Wang E, Tzvetanov I, Spaggiari M, Shetty A, Gallon L, Hachaj G, Kaplan B, Benedetti E. Personalized physical rehabilitation program and employment in kidney transplant recipients: a randomized trial. Transpl Int. 2021 Jun;34(6):1083-1092. doi: 10.1111/tri.13868. Epub 2021 Apr 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Rehabiliation | 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care |
| FG001 | Control | Standard clinical care only |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The count represents the number of participants who were unemployed at Baseline (excluding employed participants at baseline) | Posted | Count of Participants | Participants | 12 months |
|
Adverse events were not assessed in this study due to the minimal risk associated with the exercise program.
There are minimal to no risks associated with the exercise program.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Rehabiliation | 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shyreen Kamal, Director of Clinical Research | University of Illinois Chicago | 2068830173 | shyreen@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2018 | Feb 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| 12 months |
| Body Composition - DEXA | Muscle mass will be assessed via Dual-energy X-ray absorptiometry (DEXA). | 12 months |
| Metabolic State and Kidney Function - eGFR | Estimated glomerular filtration rate (eGFR) will be measured | 12 months |
| 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). | 12 months |
| Subclinical Atherosclerosis - IMT | This will be assessed through measures of carotid intima-media thickness (IMT) | 12 months |
| 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 | 12 months |
| Regular Physical Activity Using Accelerometers | Physical activity is assessed through accelerometers which give scores that are measured in m/s^2 | 12 months |
| Metabolic State and Kidney Function - Serum Creatinine (SCr) | Serum creatinine levels will be measured. | 12 months |
| 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). | 12 months |
| 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). | 12 months |
| 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 | 12 months |
| 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. | 12 months |
| 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 | 12 months |
| Body Composition - Body Mass Index (BMI) | Body mass index is calculated as weight (kg) divided by height (m) squared | 12 months |
| 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. | 12 months |
| 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. | 12 months |
Standard clinical care only |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Standard clinical care only
|
|
| Secondary | Subclinical Atherosclerosis - PWV | This will be assessed through measures of aortic pulse wave velocity (PWV) | Posted | Mean | Standard Deviation | meters/second | 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Meters | 12 months |
|
|
|
| Secondary | Body Composition - DEXA | Muscle mass will be assessed via Dual-energy X-ray absorptiometry (DEXA). | Posted | Mean | Standard Deviation | Gram | 12 months |
|
|
|
| Secondary | Metabolic State and Kidney Function - eGFR | Estimated glomerular filtration rate (eGFR) will be measured | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | 12 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | T-score | 12 months |
|
|
|
| Secondary | Subclinical Atherosclerosis - IMT | This will be assessed through measures of carotid intima-media thickness (IMT) | Posted | Mean | Standard Deviation | millimeters | 12 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Pounds | 12 months |
|
|
|
| Secondary | Regular Physical Activity Using Accelerometers | Physical activity is assessed through accelerometers which give scores that are measured in m/s^2 | Posted | Mean | Standard Deviation | m/s^2 | 12 months |
|
|
|
| Secondary | Metabolic State and Kidney Function - Serum Creatinine (SCr) | Serum creatinine levels will be measured. | Posted | Mean | Standard Deviation | mg/dL | 12 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | T-score | 12 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | T-score | 12 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Pounds | 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Inches | 12 months |
|
|
|
| Secondary | Body Composition - Body Mass Index (BMI) | Body mass index is calculated as weight (kg) divided by height (m) squared | Posted | Mean | Standard Deviation | kg/m^2 | 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control | Standard clinical care only | 0 | 0 | 0 | 0 | 0 | 0 |
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| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |