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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK090401-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated with impairment in cognition and physical function. The purpose of this study is to test the effects of 12 months of aerobic and resistance exercise training compared to health education on cognitive and physical performance in 120 older adults with CKD not requiring dialysis. The results of this study will be essential for demonstrating the effectiveness of exercise in improving function and ultimately preventing disability in this high-risk population of older adults.
This is a parallel-group randomized controlled trial comparing 12 months of aerobic and resistance exercise training vs. health education (attention control) on neurocognitive and physical performance among community-dwelling older adults (age >55) and CKD stage 3b and 4. Co-primary outcomes are change in physical performance (including aerobic capacity and submaximal walking) and neurocogntive performance (including executive functions).
Outcome measures will be assessed at baseline and after 6- and 12 months. Exercise training will occur thrice weekly at a dedicated research exercise center and will be supervised by exercise specialists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic exercise | Experimental | 12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home. |
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| Health Education | Active Comparator | 12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise training | Behavioral | 12 months of aerobic exercise |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Aerobic Capacity | VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity | Baseline, 6 months, 12 months |
| Change in 6 Minute Walk | Distance walked in 6 minutes - greater distance represents higher function | Baseline, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Function | Timed Up and Go Test | Baseline, 6 months, 12 months |
| Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum) | Short Physical Performance Battery is a test of lower extremity function designed to be administered in older adults, consisting of three components: 1) usual gait speed over a 4-meter course; 2) five repeated chair stands; 3) standing balance battery. Each component is scored 0-4, with higher scores indicating better function, and the total scores of each component are summed (range, 0-12). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center / University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36790849 | Derived | Liu CK, Miao S, Giffuni J, Katzel LI, Fielding RA, Seliger SL, Weiner DE. Geriatric Syndromes and Health-Related Quality of Life in Older Adults with Chronic Kidney Disease. Kidney360. 2023 Apr 1;4(4):e457-e465. doi: 10.34067/KID.0000000000000078. Epub 2023 Feb 14. | |
| 35944747 | Derived | Weiner DE, Liu CK, Miao S, Fielding R, Katzel LI, Giffuni J, Well A, Seliger SL. Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. Am J Kidney Dis. 2023 Jan;81(1):59-66. doi: 10.1053/j.ajkd.2022.06.008. Epub 2022 Aug 6. |
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March 2012 through June 2016 recruited from the University of Maryland Medical Center, VA Maryland Healthcare System, Tufts Medical Center, and Partners Healthcare.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aerobic Exercise | 12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home. Aerobic exercise training: 12 months of aerobic exercise |
| FG001 | Health Education | 12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month. Health Education: 12 months of health education sessions |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aerobic Exercise | 12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home. Aerobic exercise training: 12 months of aerobic exercise |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Peak Aerobic Capacity | VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity | Participants with complete V02peak at >=1 time point | Posted | Mean | Standard Deviation | ml/kg/min | Baseline, 6 months, 12 months |
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12 months or until loss to follow-up or withdrawal.
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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 | Aerobic Exercise | 12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home. Aerobic exercise training: 12 months of aerobic exercise |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All SAEs | General disorders | Systematic Assessment | SAEs were not categorized by organ system or type |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All AEs | General disorders | Systematic Assessment | Adverse Events were not categorized by organ system or type |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Seliger, MD MS | University of Maryland School of Medicine | 410-605-7000 | x55231 | sseliger@som.umaryland.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2016 | Dec 9, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Health Education |
| Behavioral |
12 months of health education sessions |
|
| Baseline, 6 months, 12 months |
| Tufts Medical Center |
| Boston |
| Massachusetts |
| 02111 |
| United States |
| BG001 | Health Education | 12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month. Health Education: 12 months of health education sessions |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Estimated glomerular filtration rate (eGFR) | Mean | Standard Deviation | ml/min/1.73m^2 |
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| Hemoglobin (g/dl) | Mean | Standard Deviation | g/dL |
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| Body Mass Index (kg/m2) | Mean | Standard Deviation | kg/m2 |
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| Self-reported Moderate-vigorous physical activity | Mean | Standard Deviation | minutes/week |
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| Coronary Artery Disease | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Heart Failure | Count of Participants | Participants |
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| Peripheral vascular disease | Count of Participants | Participants |
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| Chronic Obstructive Pulmonary Disease (COPD) | Count of Participants | Participants |
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| Study Site | Count of Participants | Participants |
|
| Health Education |
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month. Health Education: 12 months of health education sessions |
|
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| Primary | Change in 6 Minute Walk | Distance walked in 6 minutes - greater distance represents higher function | Total # with at least one measurement | Posted | Mean | Standard Deviation | Feet | Baseline, 6 months, 12 months |
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| Secondary | Change in Physical Function | Timed Up and Go Test | # of participants with complete measures | Posted | Mean | Standard Deviation | Seconds | Baseline, 6 months, 12 months |
|
|
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| Secondary | Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum) | Short Physical Performance Battery is a test of lower extremity function designed to be administered in older adults, consisting of three components: 1) usual gait speed over a 4-meter course; 2) five repeated chair stands; 3) standing balance battery. Each component is scored 0-4, with higher scores indicating better function, and the total scores of each component are summed (range, 0-12). | # of participants with complete measures | Posted | Count of Participants | Participants | Baseline, 6 months, 12 months |
|
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| 1 |
| 49 |
| 21 |
| 49 |
| 30 |
| 49 |
| EG001 | Health Education | 12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month. Health Education: 12 months of health education sessions | 2 | 50 | 34 | 50 | 31 | 50 |
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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 |
| D001519 | Behavior |
| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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