Home-Based Exercise as an Intervention to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Baylor College of Medicine
- Enrollment
- 15
- Locations
- 4
- Primary Endpoint
- Change in Short Physical Performance Battery Score
Study Overview
Brief 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), physical activity, and adverse clinical outcomes, including hospitalizations.
Detailed Description
Screening and Recruitment:
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •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
- •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
Outcomes
Primary Outcomes
Change in Short Physical Performance Battery Score
Time Frame: 8 weeks of home-based exercise
The Short Physical Performance Battery is a composite measure which includes component tests of balance, gait speed, and chair stand time. Participants receive a score of 0-4 for each of the 3 component tests with lower scores indicating worse physical function. Component scores are then summed providing a total score of 0-12 with lower scores again indicating worse physical function.
Secondary Outcomes
- Change in Physical Frailty Phenotype(8 weeks)
- Change in Grip Strength(8 weeks)
- Change in Gait Speed(8 weeks)
- Change in Exhaustion(8 weeks)
- Change in Physical Activity(8 weeks)
- Change in Quality of Life(8 weeks)
- Change in Weight(8 weeks)
- Change in Percent Body Fat(8 weeks)
- Change in Physical Frailty Phenotype(8 weeks)
Investigators
Elizabeth Coite Lorenz
Principal Investigator
Baylor College of Medicine