Rochester, Minnesota 55905

  • Kidney Transplant Candidates

Purpose:

The investigators will conduct a pilot study to determine whether home-based exercise is an effective intervention to improve decreased physical function in kidney transplant candidates. The investigators will determine if home-based exercise improves frailty parameters and SPPB scores. The investigators will also determine if home-based exercise improves health-related quality of life (HRQOL), body composition, physical activity, and adverse clinical outcomes, including hospitalizations.


Study summary:

Screening and Recruitment: Potential participants undergoing outpatient kidney transplant evaluation at Mayo Clinic Rochester will be identified. Patients who express interest in the study will go through the informed consent process with a member of the study team, and patients wishing to participate in the study will complete written consent. If patients have not had frailty and SPPB testing within the two weeks prior to consent, the study team member will perform frailty and SPPB testing at baseline in a supervised setting. Patients who are not frail or pre-frail and have a SPPB score > 10 will be ineligible for study participation. Exercise Intervention: Participants will be provided with a pedal exerciser, resistance bands, and exercise pamphlets. Participants will be asked to complete an 8-week home-based exercise program with a focus on the core components of physical activity counseling and exercise training according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. Participants will receive an individualized exercise prescription. Recommended aerobic exercises will include arm and/or leg ergometry using a pedal exerciser, and recommended resistance training will include resistance bands. During the program, participants will receive weekly semi-scripted phone calls from an exercise physiologist and gradual increases in the volume of physical activity will be recommended over time. Participants will be asked to log information regarding their exercise sessions. Study Measures: Participants will complete the Short Physical Performance Battery (SPPB), and Fried Frailty phenotype at baseline and after completion of the exercise intervention. The SPPB consists of gait speed, balance, and repeat chair stand tests. The Fried Frailty Phenotype consists of gait speed and grip strength tests, in addition to self-reported measurement of physical activity, weight loss, and exhaustion. Participants will also be asked to complete a body composition scan, complete questionnaires, and wear a physical activity monitor at baseline and after completion of the exercise intervention.


Criteria:

Inclusion Criteria: - • Age 18 years or older - Consenting to research - Approved for kidney transplant at Mayo Clinic - An SPPB score ≤10 or considered frail or pre-frail according to the Fried Frailty Phenotype Exclusion Criteria: - • Younger than 18 years - Patients being evaluated for combined organ transplantation - Significant comorbidities that limit rehabilitation potential including pulmonary disease requiring continuous oxygen supplementation, active angina, critical aortic sclerosis, decompensated heart failure, or known ventricular arrhythmia. - An SPPB score >10 or not considered frail or pre-frail by the Fried Frailty Phenotype - Non-English speaker without availability of adequate interpreter services (safety concern) - Weight > 220 lbs (exceeds weight limit for pedal exerciser)


NCT ID:

NCT04745169


Primary Contact:

Adam Miller
Phone: 507-266-8147
Email: miller.adam@mayo.edu


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States

Adam Miller
Phone: 507-266-8147
Email: miller.adam@mayo.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 24, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.