Chronic Kidney Disease
Conditions
Keywords
Chronic kidney disease, Exercise, Aerobic capacity, Learning and memory, Executive function, Endothelial function
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAerobic exercise training
12 months of aerobic exercise
BEHAVIORALHealth Education
12 months of health education sessions
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Stage 3-4 Chronic kidney disease (estimated Glomerular Filtration Rate 15-45) * Age 60 to 85 * English Speaking
Exclusion criteria
* Dementia or cognitive impairment * Renal transplant * New York Heart Association class 3-4 heart failure * Severe Chronic Lung Disease * Unstable angina or coronary revascularization within the last 3 months * Orthopedic problems that would preclude aerobic exercise training * Known, untreated infection * Disabling arthritis * Uncontrolled arrhythmia * More than 14 alcoholic drinks per week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Aerobic Capacity | Baseline, 6 months, 12 months | VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity |
| Change in 6 Minute Walk | Baseline, 6 months, 12 months | Distance walked in 6 minutes - greater distance represents higher function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Function | Baseline, 6 months, 12 months | Timed Up and Go Test |
| Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum) | Baseline, 6 months, 12 months | 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). |
Countries
United States
Participant flow
Recruitment details
March 2012 through June 2016 recruited from the University of Maryland Medical Center, VA Maryland Healthcare System, Tufts Medical Center, and Partners Healthcare.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| 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 | 50 |
| Total | 99 |
Baseline characteristics
| Characteristic | Aerobic Exercise | Health Education | Total |
|---|---|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 7.7 | 68.1 years STANDARD_DEVIATION 8.8 | 68.0 years STANDARD_DEVIATION 8.2 |
| Body Mass Index (kg/m2) | 30.3 kg/m2 STANDARD_DEVIATION 7.2 | 31.8 kg/m2 STANDARD_DEVIATION 5.8 | 31.1 kg/m2 STANDARD_DEVIATION 6.5 |
| Chronic Obstructive Pulmonary Disease (COPD) | 5 Participants | 8 Participants | 13 Participants |
| Coronary Artery Disease | 16 Participants | 13 Participants | 29 Participants |
| Diabetes | 30 Participants | 28 Participants | 58 Participants |
| Estimated glomerular filtration rate (eGFR) | 34.1 ml/min/1.73m^2 STANDARD_DEVIATION 9.5 | 32.6 ml/min/1.73m^2 STANDARD_DEVIATION 11.4 | 33.3 ml/min/1.73m^2 STANDARD_DEVIATION 10.5 |
| Heart Failure | 6 Participants | 4 Participants | 10 Participants |
| Hemoglobin (g/dl) | 12.5 g/dL STANDARD_DEVIATION 1.6 | 12.3 g/dL STANDARD_DEVIATION 1.7 | 12.4 g/dL STANDARD_DEVIATION 1.6 |
| Hypertension | 44 Participants | 48 Participants | 92 Participants |
| Peripheral vascular disease | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized African-American | 27 Participants | 34 Participants | 61 Participants |
| Race/Ethnicity, Customized Caucasian | 18 Participants | 13 Participants | 31 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 3 Participants | 7 Participants |
| Region of Enrollment United States | 49 participants | 50 participants | 99 participants |
| Self-reported Moderate-vigorous physical activity | 72 minutes/week STANDARD_DEVIATION 126 | 90 minutes/week STANDARD_DEVIATION 174 | 78 minutes/week STANDARD_DEVIATION 150 |
| Sex: Female, Male Female | 15 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Male | 34 Participants | 40 Participants | 74 Participants |
| Study Site Tufts | 21 Participants | 22 Participants | 43 Participants |
| Study Site Univ Maryland | 28 Participants | 28 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 49 | 2 / 50 |
| other Total, other adverse events | 30 / 49 | 31 / 50 |
| serious Total, serious adverse events | 21 / 49 | 34 / 50 |
Outcome results
Primary
Change in 6 Minute Walk
Distance walked in 6 minutes - greater distance represents higher function
Time frame: Baseline, 6 months, 12 months
Population: Total # with at least one measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise | Change in 6 Minute Walk | Baseline | 1298 Feet | Standard Deviation 323 |
| Aerobic Exercise | Change in 6 Minute Walk | 6 months | 1649 Feet | Standard Deviation 620 |
| Aerobic Exercise | Change in 6 Minute Walk | 12 months | 1453 Feet | Standard Deviation 368 |
| Health Education | Change in 6 Minute Walk | Baseline | 1251 Feet | Standard Deviation 394 |
| Health Education | Change in 6 Minute Walk | 6 months | 1247 Feet | Standard Deviation 454 |
| Health Education | Change in 6 Minute Walk | 12 months | 1284 Feet | Standard Deviation 462 |
Primary
Change in Peak Aerobic Capacity
VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity
Time frame: Baseline, 6 months, 12 months
Population: Participants with complete V02peak at \>=1 time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise | Change in Peak Aerobic Capacity | Baseline | 17.1 ml/kg/min | Standard Deviation 5.3 |
| Aerobic Exercise | Change in Peak Aerobic Capacity | 6 months | 17.9 ml/kg/min | Standard Deviation 5.5 |
| Aerobic Exercise | Change in Peak Aerobic Capacity | 12 Months | 18.7 ml/kg/min | Standard Deviation 5.2 |
| Health Education | Change in Peak Aerobic Capacity | Baseline | 16.8 ml/kg/min | Standard Deviation 5.6 |
| Health Education | Change in Peak Aerobic Capacity | 6 months | 15.9 ml/kg/min | Standard Deviation 7 |
| Health Education | Change in Peak Aerobic Capacity | 12 Months | 17.2 ml/kg/min | Standard Deviation 6.4 |
Secondary
Change in Physical Function
Timed Up and Go Test
Time frame: Baseline, 6 months, 12 months
Population: \# of participants with complete measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise | Change in Physical Function | Baseline | 8.2 Seconds | Standard Deviation 2.4 |
| Aerobic Exercise | Change in Physical Function | 6 months | 8.0 Seconds | Standard Deviation 2.6 |
| Aerobic Exercise | Change in Physical Function | 12 months | 8.3 Seconds | Standard Deviation 29 |
| Health Education | Change in Physical Function | Baseline | 8.6 Seconds | Standard Deviation 2.7 |
| Health Education | Change in Physical Function | 6 months | 9.3 Seconds | Standard Deviation 3.6 |
| Health Education | Change in Physical Function | 12 months | 9.0 Seconds | Standard Deviation 2.9 |
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).
Time frame: Baseline, 6 months, 12 months
Population: \# of participants with complete measures
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aerobic Exercise | Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum) | Baseline | 19 Participants |
| Aerobic Exercise | Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum) | 6 months | 9 Participants |
| Aerobic Exercise | Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum) | 12 months | 9 Participants |
| Health Education | Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum) | Baseline | 19 Participants |
| Health Education | Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum) | 6 months | 15 Participants |
| Health Education | Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum) | 12 months | 16 Participants |