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

NCT04745169 | Completed Results

• 1 other identifier: H-52019
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change in Short Physical Performance Battery Score

  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.

  8 weeks of home-based exercise

Secondary Outcomes (8)

• 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

Study Arms (1)

Intervention

OTHER

Participants will be asked to complete an 8-week home-based exercise intervention

Behavioral: 8 week home-based exercise program

Interventions

8 week home-based exercise program BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Mayo Clinic: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elizabeth Lorenz, MD
• Organization: Baylor College of Medicine

elizabeth.lorenz@bcm.edu

713-798-2694

Study Officials

• Elizabeth C Lorenz, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 9, 2021
• Study Start: December 21, 2020
• Primary Completion: November 16, 2023
• Study Completion: November 16, 2023
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-08

Locations

US (2)