search
Back to results

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

Primary Purpose

Chronic Kidney Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
8 week home-based exercise program
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or older
  • Consenting to research
  • Approved for kidney transplant at Mayo Clinic -OR- 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

Sites / Locations

  • Mayo Clinic
  • Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in grip strength
Grip strength will be measured using a hand-held dynamometer.
Change in gait speed
Gait speed at the participant's self-selected walking speed will be measured.
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.
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.
Wasting
Wasting is defined as an unintentional weight loss of 10 or more pounds in one year.
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.
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.

Full Information

First Posted
January 29, 2021
Last Updated
April 6, 2023
Sponsor
Baylor College of Medicine
Collaborators
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT04745169
Brief Title
Home-Based Exercise as an Intervention 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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
Participants will be asked to complete an 8-week home-based exercise intervention
Intervention Type
Behavioral
Intervention Name(s)
8 week home-based exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Short Physical Performance Battery score
Description
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.
Time Frame
8 weeks of home-based exercise
Secondary Outcome Measure Information:
Title
Change in grip strength
Description
Grip strength will be measured using a hand-held dynamometer.
Time Frame
8 weeks
Title
Change in gait speed
Description
Gait speed at the participant's self-selected walking speed will be measured.
Time Frame
8 weeks
Title
Change in exhaustion
Description
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.
Time Frame
8 weeks
Title
Change in physical activity
Description
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.
Time Frame
8 weeks
Title
Wasting
Description
Wasting is defined as an unintentional weight loss of 10 or more pounds in one year.
Time Frame
8 weeks
Title
Change in quality of life
Description
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.
Time Frame
8 weeks
Title
Post-transplant 30-day rehospitalizations
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merin Thomas
Phone
713-798-7291
Email
merin.thomas@bcm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth C Lorenz, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Suspended
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merin Thomas
Phone
713-798-7291
Email
merin.thomas@bcm.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth C Lorenz, MD

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs