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Exercise Intervention on Frailty After Kidney Transplantation

Primary Purpose

Kidney Transplant

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Program
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Kidney Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients age ≥ 18 years who have received a KT and have a functioning allograft

Exclusion Criteria:

  • Neuropsychiatric condition causing patient to be unable to provide consent
  • Recipient of a combined organ transplant

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care Group

Exercise Intervention Group

Arm Description

Subjects will receive no formal exercise recommendations

Subjects will complete an exercise program

Outcomes

Primary Outcome Measures

Change in frailty status
Frailty will be determined by Frailty Phenotype (FP) or Short Physical Performance Battery (SPPB) scores. FP is determined by the presence of 3 or more of the following: slowness (measured by gait speed), exhaustion (measured via self-report), weakness (measured by hand grip strength), low physical activity level (measured via self-report), and wasting (measured via self-report or by tracking changes in weight). The SPPB consists of a gait speed test, balance testing, and repeated chair stands. A score less than or equal to 10 will be considered frail.

Secondary Outcome Measures

Full Information

First Posted
February 13, 2020
Last Updated
April 7, 2022
Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04275752
Brief Title
Exercise Intervention on Frailty After Kidney Transplantation
Official Title
Examining the Preliminary Efficacy, Feasibility, and Acceptability of an Exercise Intervention on Frailty After Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Original funding for this study changed and it is no longer being pursued
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Researchers are trying to determine if exercise will improve health and strength in kidney transplant patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
Subjects will receive no formal exercise recommendations
Arm Title
Exercise Intervention Group
Arm Type
Experimental
Arm Description
Subjects will complete an exercise program
Intervention Type
Other
Intervention Name(s)
Exercise Program
Intervention Description
Perform endurance (treadmill or cycle ergometer), strength (weight resistance), and flexibility training twice a week for a period of one hour per session, for a total of 16 sessions.
Primary Outcome Measure Information:
Title
Change in frailty status
Description
Frailty will be determined by Frailty Phenotype (FP) or Short Physical Performance Battery (SPPB) scores. FP is determined by the presence of 3 or more of the following: slowness (measured by gait speed), exhaustion (measured via self-report), weakness (measured by hand grip strength), low physical activity level (measured via self-report), and wasting (measured via self-report or by tracking changes in weight). The SPPB consists of a gait speed test, balance testing, and repeated chair stands. A score less than or equal to 10 will be considered frail.
Time Frame
Two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients age ≥ 18 years who have received a KT and have a functioning allograft Exclusion Criteria: Neuropsychiatric condition causing patient to be unable to provide consent Recipient of a combined organ transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Lorenz, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Exercise Intervention on Frailty After Kidney Transplantation

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