Kidney TransplantNCT02409901
Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients
A study testing Exercise Rehabilitation in people with Kidney Transplant, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Exercise Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 2 moths post-transplant
- must have adequate cognitive ability to complete questionnaires, give consent for the study and follow the physical instructions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Randomized Case-Control Trial About the Impact of Targeted Physical Activity and Diet Modification on Kidney Transplant Recipients' Outcome
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.
Read the 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.
- Conditions
- Kidney Transplant
- Being tested
- Exercise Rehabilitation
- Keywords
- Physical Activity, Exercise Rehabilitation, Kidney Function, Employment, Kidney Transplant
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise RehabilitationBehavioural
12 month personalized exercise rehabilitation in addition to standard clinical care
| Study group | Role | What they receive |
|---|---|---|
| Exercise Rehabilitation | Experimental | 12 month personalized exercise rehabilitation in addition to standard clinical care Receives: Behavioral: Exercise Rehabilitation |
| Control | No intervention | Standard clinical care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (17)
Subclinical Atherosclerosis - PWV
This will be assessed through measures of aortic pulse wave velocity (PWV)
Measured: 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.
Measured: 12 months
Body Composition - DEXA
Muscle mass will be assessed via Dual-energy X-ray absorptiometry (DEXA).
Measured: 12 months
Metabolic State and Kidney Function - eGFR
Estimated glomerular filtration rate (eGFR) will be measured
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).
Measured: 12 months
Subclinical Atherosclerosis - IMT
This will be assessed through measures of carotid intima-media thickness (IMT)
Measured: 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
Measured: 12 months
Regular Physical Activity Using Accelerometers
Physical activity is assessed through accelerometers which give scores that are measured in m/s^2
Measured: 12 months
Metabolic State and Kidney Function - Serum Creatinine (SCr)
Serum creatinine levels will be measured.
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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 12 months
Body Composition - Body Mass Index (BMI)
Body mass index is calculated as weight (kg) divided by height (m) squared
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionApr 2019
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Benedetti, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409901
- Sponsor's protocol ID
- 2011-0808
- Status last verified
- Sep 2024
- First submitted
- 26 Mar 2015
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 33733479
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Case-Control Trial About the Impact of Targeted Physical Activity and Diet Modification on Kidney Transplant Recipients' Outcome
- ClinicalTrials.gov ID
- NCT02409901
- Acronym / sponsor ID
- 2011-0808
- Conditions
- Kidney Transplant
- Keywords
- Physical Activity, Exercise Rehabilitation, Kidney Function, Employment, Kidney Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2019 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Rehabilitation | Experimental | Behavioral: Exercise Rehabilitation12 month personalized exercise rehabilitation in addition to standard clinical care |
| Control | No intervention | –Standard clinical care only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 2 moths post-transplant
- must have adequate cognitive ability to complete questionnaires, give consent for the study and follow the physical instructions
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Rehabilitation12 month personalized exercise rehabilitation in addition to standard clinical care | Behavioural | Exercise Rehabilitation |
Primary outcome
Employment Status
Time frame: 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.
17 secondary outcomes
Subclinical Atherosclerosis - PWV
Time frame: 12 months
Functional Capacity - 6MW
Time frame: 12 months
Body Composition - DEXA
Time frame: 12 months
Metabolic State and Kidney Function - eGFR
Time frame: 12 months
Quality of Life and Perceived Health Status - PROMIS 10 Global Physical Health Score
Time frame: 12 months
Subclinical Atherosclerosis - IMT
Time frame: 12 months
Functional Capacity - Strength (Away)
Time frame: 12 months
Regular Physical Activity Using Accelerometers
Time frame: 12 months
Metabolic State and Kidney Function - Serum Creatinine (SCr)
Time frame: 12 months
Quality of Life and Perceived Health Status - PROMIS 29 Physical Function Score
Time frame: 12 months
Quality of Life and Perceived Health Status - PROMIS 10 Global Mental Health Score
Time frame: 12 months
Functional Capacity - Strength (Towards)
Time frame: 12 months
Pain Intensity
Time frame: 12 months
Body Composition - Waist Circumference
Time frame: 12 months
Body Composition - Body Mass Index (BMI)
Time frame: 12 months
Systolic Blood Pressure
Time frame: 12 months
Diastolic Blood Pressure
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33733479Kastelz 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Rehabilitation in people with Kidney Transplant, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Employment Status (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.