Clinical trial NCT02409901: Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients
Official title: Randomized Case-Control Trial About the Impact of Targeted Physical Activity and Diet Modification on Kidney Transplant Recipients' Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Keywords: Physical Activity
Exercise Rehabilitation
Kidney Function
Employment
Kidney Transplant
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Employment Status
timeFrame: 12 months
Secondary outcomes:
measure: Subclinical Atherosclerosis - PWV
timeFrame: 12 months
measure: Functional Capacity - 6MW
timeFrame: 12 months
measure: Body Composition - DEXA
timeFrame: 12 months
measure: Metabolic State and Kidney Function - eGFR
timeFrame: 12 months
measure: Quality of Life and Perceived Health Status - PROMIS 10 Global Physical Health Score
timeFrame: 12 months
measure: Subclinical Atherosclerosis - IMT
timeFrame: 12 months
measure: Functional Capacity - Strength (Away)
timeFrame: 12 months
measure: Regular Physical Activity Using Accelerometers
timeFrame: 12 months
measure: Metabolic State and Kidney Function - Serum Creatinine (SCr)
timeFrame: 12 months
measure: Quality of Life and Perceived Health Status - PROMIS 29 Physical Function Score
timeFrame: 12 months
measure: Quality of Life and Perceived Health Status - PROMIS 10 Global Mental Health Score
timeFrame: 12 months
measure: Functional Capacity - Strength (Towards)
timeFrame: 12 months
measure: Pain Intensity
timeFrame: 12 months
measure: Body Composition - Waist Circumference
timeFrame: 12 months
measure: Body Composition - Body Mass Index (BMI)
timeFrame: 12 months
measure: Systolic Blood Pressure
timeFrame: 12 months
measure: Diastolic Blood Pressure
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References:
citation: 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.