Clinical trial NCT04745169: Home-Based Exercise to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function
Official title: Home-Based Exercise as an Intervention to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2021-02-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot study to be conducted at Baylor College of Medicine in Houston, TX examining the feasibility, safety, acceptability, and preliminary efficacy of home-based exercise on frailty parameters and SPPB score in patients with varying levels of kidney function. The effects of exercise on HRQOL, physical activity, and adverse outcomes including hospitalizations, will also be explored.
Primary purpose: PREVENTION

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Short Physical Performance Battery score
timeFrame: 8 weeks of home-based exercise
Secondary outcomes:
measure: Change in grip strength
timeFrame: 8 weeks
measure: Change in gait speed
timeFrame: 8 weeks
measure: Change in exhaustion
timeFrame: 8 weeks
measure: Change in physical activity
timeFrame: 8 weeks
measure: Wasting
timeFrame: 8 weeks
measure: Change in quality of life
timeFrame: 8 weeks
measure: Change in weight
timeFrame: 8 weeks
measure: Change in percent body fat
timeFrame: 8 weeks
measure: Change in Physical Frailty Phenotype
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Elizabeth C Lorenz, MD
role: PRINCIPAL_INVESTIGATOR
References: