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NCT04275752 Clinical Trial

Exercise Intervention on Frailty After Kidney Transplantation

Kidney Transplant Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04275752
Other study ID # 19-008545
Secondary ID K23DK123313-01
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date May 30, 2022

Study information
Verified date April 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 30, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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