Exercise Intervention on Frailty After Kidney Transplantation

Examining the Preliminary Efficacy, Feasibility, and Acceptability of an Exercise Intervention on Frailty After Kidney Transplantation

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

Study Overview

• Status: Withdrawn
• Conditions: Kidney Transplant
• Intervention / Treatment: Other: Exercise Program

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Group; Subjects will receive no formal exercise recommendations
Experimental: Exercise Intervention Group; Subjects will complete an exercise program	Other: Exercise Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Two months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Elizabeth Lorenz, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 19-008545; K23DK123313-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No