NCT02409901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

September 1, 2024

Enrollment Period

4.5 years

First QC Date

March 26, 2015

Results QC Date

June 8, 2023

Last Update Submit

September 5, 2024

Conditions

Kidney Transplant

Keywords

Physical ActivityExercise RehabilitationKidney FunctionEmploymentKidney Transplant

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (17)

  • Subclinical Atherosclerosis - PWV

    12 months

  • Functional Capacity - 6MW

    12 months

  • Body Composition - DEXA

    12 months

  • Metabolic State and Kidney Function - eGFR

    12 months

  • Quality of Life and Perceived Health Status - PROMIS 10 Global Physical Health Score

    12 months

  • +12 more secondary outcomes

Study Arms (2)

Exercise Rehabilitation

EXPERIMENTAL

12 month personalized exercise rehabilitation in addition to standard clinical care

Behavioral: Exercise Rehabilitation

Control

NO INTERVENTION

Standard clinical care only

Interventions

Exercise RehabilitationBEHAVIORAL

12 month personalized exercise rehabilitation in addition to standard clinical care

Exercise Rehabilitation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 2 moths post-transplant
  • must have adequate cognitive ability to complete questionnaires, give consent for the study and follow the physical instructions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • 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.

    PMID: 33733479DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Results Point of Contact

Title
Shyreen Kamal, Director of Clinical Research
Organization
University of Illinois Chicago
shyreen@uic.edu
2068830173

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head of Department of Surgery

Study Record Dates

First Submitted

March 26, 2015

First Posted

April 7, 2015

Study Start

October 1, 2014

Primary Completion

April 1, 2019

Study Completion

August 1, 2021

Last Updated

November 12, 2024

Results First Posted

November 12, 2024

Record last verified: 2024-09

Locations

US(1)