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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | Participants will be asked to complete an 8-week home-based exercise intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Grip Strength | Grip strength will be measured using a hand-held dynamometer. | 8 weeks |
| Change in Gait Speed | Gait speed at the participant's self-selected walking speed will be measured. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth C Lorenz, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Baylor College of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Participants will be asked to complete an 8-week home-based exercise intervention 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Participants will be asked to complete an 8-week home-based exercise intervention 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Median difference in 8-week score compared to baseline score | Posted | Median | Inter-Quartile Range | units on a scale | 8 weeks of home-based exercise |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Participants will be asked to complete an 8-week home-based exercise intervention 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Lorenz, MD | Baylor College of Medicine | 713-798-2694 | elizabeth.lorenz@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2024 | Jul 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2024 | Jul 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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.
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|
| 8 weeks |
| 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. Energy/fatigue scores on the Kidney Disease Quality of Life Short Form (KDQOL-SF) will also be calculated. Energy/fatigue scores range from 0 to 100 points with a higher number of points indicating a worse outcome. | 8 weeks |
| 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 |
| 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 |
| Change in Weight | Weight will be measured using a scale. | 8 weeks |
| Change in Percent Body Fat | Change in percent body fat from baseline to 8 weeks was measured in the subset of participants from Mayo Clinic using bioelectrical impedance analysis. | 8 weeks |
| Change in Physical Frailty Phenotype | The Physical Frailty Phenotype score is based on 5 criteria: unintentional weight loss, exhaustion, low physical activity, slowness, weakness. Participants receive a score of 1 for each criterion they meet. The criterion scores are then summed to provide a total score ranging from 0-5 with higher scores indicating greater frailty. Specifically, a total score of 0 indicates that the participant is not frail, a score of 1-2 indicates that the participant is pre-frail, and a score of 3-5 indicates that the participant is frail. | 8 weeks |
| Houston |
| Texas |
| 77030 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dialysis dependent | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Never smoked | Count of Participants | Participants |
|
| Body mass index | Median | Inter-Quartile Range | kg/m^2 |
|
| Physical Frailty Phenotype score | The Physical Frailty Phenotype score is based on 5 criteria: unintentional weight loss, exhaustion, low physical activity, slowness, weakness. Participants receive a score of 1 for each criterion they meet. The criterion scores are then summed to provide a total score ranging from 0-5 with higher scores indicating greater frailty. Specifically, a total score of 0 indicates that the participant is not frail, a score of 1-2 indicates that the participant is pre-frail, and a score of 3-5 indicates that the participant is frail. | Median | Inter-Quartile Range | units on a scale |
|
| 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. | Median | Inter-Quartile Range | units on a scale |
|
|
|
|
| Secondary | Change in Grip Strength | Grip strength will be measured using a hand-held dynamometer. | Median difference in 8-week grip strength compared to baseline | Posted | Median | Inter-Quartile Range | kilograms | 8 weeks |
|
|
|
|
| Secondary | Change in Gait Speed | Gait speed at the participant's self-selected walking speed will be measured. | Median difference in 8-week gait speed compared to baseline | Posted | Median | Inter-Quartile Range | meters/second | 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. Energy/fatigue scores on the Kidney Disease Quality of Life Short Form (KDQOL-SF) will also be calculated. Energy/fatigue scores range from 0 to 100 points with a higher number of points indicating a worse outcome. | Median difference in 8-week energy/fatigue score compared to baseline score | Posted | Median | Inter-Quartile Range | score on a scale | 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. | Median difference in moderate to vigorous physical activity at 8-week score compared to baseline | Posted | Median | Inter-Quartile Range | hours per day | 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. | Median difference in 8-week mental health score compared to baseline score | Posted | Median | Inter-Quartile Range | score on a scale | 8 weeks |
|
|
|
|
| Secondary | Change in Weight | Weight will be measured using a scale. | Median difference in 8-week weight compared to baseline | Posted | Median | Inter-Quartile Range | kilograms | 8 weeks |
|
|
|
|
| Secondary | Change in Percent Body Fat | Change in percent body fat from baseline to 8 weeks was measured in the subset of participants from Mayo Clinic using bioelectrical impedance analysis. | Median difference in 8-week percent body fat compared to baseline | Posted | Median | Inter-Quartile Range | percentage of body fat | 8 weeks |
|
|
|
|
| Secondary | Change in Physical Frailty Phenotype | The Physical Frailty Phenotype score is based on 5 criteria: unintentional weight loss, exhaustion, low physical activity, slowness, weakness. Participants receive a score of 1 for each criterion they meet. The criterion scores are then summed to provide a total score ranging from 0-5 with higher scores indicating greater frailty. Specifically, a total score of 0 indicates that the participant is not frail, a score of 1-2 indicates that the participant is pre-frail, and a score of 3-5 indicates that the participant is frail. | Median difference in 8-week score compared to baseline score | Posted | Median | Inter-Quartile Range | units on a scale | 8 weeks |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 3 |
| 15 |
| Persistent musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |