Clinical Trials Directory

Trials / Completed

CompletedNCT04745169

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Baylor College of Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORAL8 week home-based exercise programParticipants 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.

Timeline

Start date
2020-12-21
Primary completion
2023-11-16
Completion
2023-11-16
First posted
2021-02-09
Last updated
2025-08-17
Results posted
2025-08-17

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04745169. Inclusion in this directory is not an endorsement.