Physical Activity and Diet on Kidney Transplant Recipients
Status: | Recruiting |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | October 2014 |
Contact: | Alexandra H Kastelz, MSc |
Email: | kastelza@uic.edu |
Phone: | 312-996-3687 |
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.
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.
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.
Inclusion Criteria:
- 2-18 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
- 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
We found this trial at
1
site
2035 W Taylor St
Chicago, Illinois
Chicago, Illinois
(312) 996-4350
Principal Investigator: Enrico Benedetti, MD
Phone: 312-996-3687
University of Illinois at Chicago A major research university in the heart of one of...
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