NCT04275752

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

27 days

First QC Date

February 13, 2020

Last Update Submit

April 7, 2022

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Usual Care Group

NO INTERVENTION

Subjects will receive no formal exercise recommendations

Exercise Intervention Group

EXPERIMENTAL

Subjects will complete an exercise program

Other: Exercise Program

Interventions

Exercise ProgramOTHER

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.

Exercise Intervention Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elizabeth Lorenz, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

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
Principal Investigator

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 19, 2020

Study Start

February 1, 2022

Primary Completion

February 28, 2022

Study Completion

May 30, 2022

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)