Home-Based Exercise to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function
NCT ID: NCT04745169
Last Updated: 2025-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2020-12-21
2023-11-16
Brief Summary
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Detailed Description
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Potential participants will be identified from dialysis units, nephrology clinics, primary care clinics, or kidney transplant clinics at Baylor College of Medicine. 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 questionnaires and wear a physical activity monitor at baseline and after completion of the exercise intervention.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Intervention
Participants will be asked to complete an 8-week home-based exercise intervention
8 week home-based exercise program
Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.
Interventions
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8 week home-based exercise program
Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.
Eligibility Criteria
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Inclusion Criteria
* Consenting to research
* Chronic kidney disease (stages 1-5)
* An SPPB score ≤10 or considered frail or pre-frail according to the Fried Frailty Phenotype
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
National Institutes of Health (NIH)
NIH
Baylor College of Medicine
OTHER
Responsible Party
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Elizabeth Coite Lorenz
Principal Investigator
Principal Investigators
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Elizabeth C Lorenz, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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H-52019
Identifier Type: -
Identifier Source: org_study_id
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