NCT02986243

Brief Summary

The purpose of this study is to determine if an assigned physical fitness program will result in weight loss to prepare patients for kidney transplant.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Feb 2016

Longer than P75 for not_applicable

Status
active not recruiting

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 Progress93%
Feb 2016Mar 2027

Study Start

First participant enrolled

February 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

11.1 years

First QC Date

November 30, 2016

Last Update Submit

March 5, 2026

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    The difference in starting weight and ending weight six months after beginning exercise program will be measured.

    6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects receive a diet plan and exercise regimen.

Other: ExerciseDietary Supplement: Diet Plan

Interventions

ExerciseOTHER

6 months worth of exercise regimen

Treatment
Diet PlanDIETARY_SUPPLEMENT

Each subject will receive a personalized diet plan from nutritionist.

Treatment

Eligibility Criteria

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

You may qualify if:

  • Adult patients over 18 years of age and older but less than 65
  • All patients who are currently listed as "inactive" on the University of Chicago kidney transplant wait list
  • Those with a body mass index of 40-44
  • Those with access to the Internet
  • Have transportation to the fitness center (Formula Fitness Center at Union Station location)

You may not qualify if:

  • Those patients who are listed "inactive" on the wait-list due to co-morbid conditions other than obesity
  • Those who are unwilling to attend fitness center appointments
  • Those who do not have adequate transportation to the fitness center
  • Those who do not have access to the Internet
  • Those who are not comfortable navigating and using the Internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 8, 2016

Study Start

February 1, 2016

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share