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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04745169
• Other study ID #: H-52019
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Short Physical Performance Battery score	The Short Physical Performance Battery consists of gait speed, balance, and repeated chair stand tests. The minimum score is 0, and the maximum score is 12. Higher scores indicate better physical function.	8 weeks of home-based exercise
Secondary	Change in grip strength	Grip strength will be measured using a hand-held dynamometer.	8 weeks
Secondary	Change in gait speed	Gait speed at the participant's self-selected walking speed will be measured.	8 weeks
Secondary	Change in exhaustion	Patients will self-report their level of exhaustion using the Center for Epidemiologic Studies Depression Scale (CES-D) which consists of a 4-point scale. Items on the CES-D are scored from minimum to maximum values (1 point to 4 points) which are indicated on the CES-D as "rarely or none of the time," "some or a little of the time," "occasionally or a moderate amount of time," "most or all of the time," respectively. A higher number of points indicates a worse outcome.	8 weeks
Secondary	Change in physical activity	Energy expenditure will be measured using an activity monitor worn on the wrist for 7 days. Low activity is defined as activity in the lowest 20% (<383 Kcals/week for men or <270 Kcals/week for women). Patients will also self-report their activity level using the Minnesota Leisure Time Physical Activity Questionnaire.	8 weeks
Secondary	Wasting	Wasting is defined as an unintentional weight loss of 10 or more pounds in one year.	8 weeks
Secondary	Change in quality of life	Health-related quality of life will be measured using the Kidney Disease Quality of Life Short Form. This questionnaire includes scales with minimum values of 0 and maximum values of 100. Higher scores indicate better quality of life.	8 weeks
Secondary	Post-transplant 30-day rehospitalizations	The relationship between exercise, physical function, and post-transplant 30-day rehospitalizations will be examined for patients who receive a kidney transplant within 1 year of enrolling in this study.	1 year

External Links

•   Mayo Clinic Clinical Trials