Home-Based Exercise as an Intervention to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    40
  • sponsor
    Mayo Clinic
Updated on 23 March 2022

Summary

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.

Description

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.

Details
Condition Kidney Transplant Candidates
Treatment 8 week home-based exercise program
Clinical Study IdentifierNCT04745169
SponsorMayo Clinic
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or older
Consenting to research
Approved for kidney transplant at Mayo Clinic -OR- Chronic kidney disease (stages 1-5)
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)
Failure to pass submaximal exercise test in patients not approved for kidney transplantation at our center
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