Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients

Kidney Transplant Clinical Trial

Official title:

Randomized Case-Control Trial About the Impact of Targeted Physical Activity and Diet Modification on Kidney Transplant Recipients' Outcome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02409901
• Other study ID #: 2011-0808
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2014
• Est. completion date: April 2025

Study information

• Verified date: June 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 153
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Behavioral:
• Exercise Rehabilitation
12 month personalized exercise rehabilitation in addition to standard clinical care

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

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