Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients

June 8, 2021 updated by: Enrico Benedetti, University of Illinois at Chicago

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Rehabiliation
12 month personalized exercise rehabilitation in addition to standard clinical care
Behavioral: Exercise Rehabilitation
12 month personalized exercise rehabilitation in addition to standard clinical care
No Intervention: Control
Standard clinical care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return to work or find work rate
Time Frame: 12 months
This will be assessed through verbal questioning on current employment status
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subclinical atherosclerosis
Time Frame: 12 months
This will be assessed through measures of aortic pulse wave velocity (PWV)
12 months
Functional capacity
Time Frame: 12 months
This will be assessed through the 6 minute walk test (6MW)
12 months
Body Composition
Time Frame: 12 months
Fat and lean muscle mass will be assessed via Dual-energy X-ray absorptiometry (DXA).
12 months
Metabolic state and Kidney Function
Time Frame: 12 months
Fasting blood lipid profile will be measured
12 months
Quality of life and perceived health status
Time Frame: 12 months
The Patient Reported Outcomes Measurement Information System (PROMIS) v.1.1 - Global Health short form will be administered to all patients to assess perception of general health.
12 months
Subclinical atherosclerosis
Time Frame: 12 months
This will be assessed through measures of carotid intima-media thickness (IMT)
12 months
Subclinical atherosclerosis
Time Frame: 12 months
This will be assessed through measures of endothelial function and carotid arterial stiffness via flow mediated dilation (FMD).
12 months
Functional capacity
Time Frame: 12 months
This will be assessed through measures of unilateral isometric strength utilizing Biodex.
12 months
Regular physical activity
Time Frame: 12 months
This will be assessed through free-living accelerometry
12 months
Inflammatory marker
Time Frame: 12 months
C-reactive protein(CRP)
12 months
Metabolic state and Kidney Function
Time Frame: 12 months
Glomerular filtration rate (GFR) will be measured
12 months
Metabolic state and Kidney Function
Time Frame: 12 months
Creatinine levels will be measured.
12 months
Quality of life and perceived health status
Time Frame: 12 months
The PROMIS 29 Profile v2.0 will be administered to all patients to assess perception of general health.
12 months
Pro-inflammatory cytokines
Time Frame: 12 month
IL-6 will be measured.
12 month
Pro-inflammatory cytokines
Time Frame: 12 month
IL-1 will be measured.
12 month
Pro-inflammatory cytokines
Time Frame: 12 month
TNF-alpha will be measured.
12 month
Pro-inflammatory cytokines
Time Frame: 12 month
Homocysteine will be measured.
12 month
Pro-inflammatory cytokines
Time Frame: 12 month
Adiponectin will be measured.
12 month
Pro-inflammatory cytokines
Time Frame: 12 month
Leptin will be measured.
12 month
Pro-inflammatory cytokines
Time Frame: 12 month
Resistin will be measured
12 month
Pro-regenerative cytokines
Time Frame: 12 month
TGF-beta will be measured
12 month
Pro-regenerative cytokines
Time Frame: 12 month
IL-10 will be measured
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011-0808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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