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The goal of this pilot randomized controlled trial is to examine the feasibility and safety of a 12-week high-velocity resistance training (HVRT) intervention in older adults with chronic kidney disease (CKD) stages 4-5 and to generate preliminary data to inform a future study investigating the efficacy of HVRT for improving muscle power and physical function. Researchers will compare HVRT to an attention control condition consisting of weekly group sessions covering topics on healthy lifestyle. This study seeks to:
Older adults with advanced chronic kidney disease (CKD) commonly exhibit severe impairments in physical function (i.e., inability to perform activities of daily living). Muscle power-the product of muscle force and velocity of contraction- is now widely considered to be a critical determinant of physical function in older adults. Despite this, muscle power has been largely overlooked in the aims and outcomes of exercise interventions for patients with CKD. Several clinical trials have shown that high-velocity resistance training (HVRT) programs consisting of functional movements performed "as fast as possible" with low external loads are safe and effective for improving muscle power and physical function in older adults. However, the available evidence on the effects of exercise interventions designed to improve muscle power in patients with CKD is scarce. This study seeks to determine whether an HVRT intervention in mobility-limited older adults with advanced CKD is feasible, safe, and potentially effective for improving muscle power and physical function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Velocity Resistance Training (HVRT) | Experimental | Those assigned to HVRT will attend three small-group (two to five people) exercise sessions lasting 60-75 minutes per week consisting of upper- and lower-body movements performed with weighted vests, medicine balls, and resistance bands. For all exercises, the concentric phase (muscle-shortening portion) will be performed as quickly as possible while maintaining good form, followed by a 1-second pause and then the eccentric phase (lengthening portion) completed in a slow and controlled fashion. Following completion of the 12-week intervention, all participants will be asked to complete the same baseline tests to assess changes in physical function, body composition, quality of life, and cognitive function outcomes. |
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| Control Group | Active Comparator | Participants randomized to the attention control group will receive dedicated contact, information, and motivation throughout the course of the intervention via weekly group sessions and informational handouts. Each in-person group meeting will last approximately one hour. These group sessions will take place in a classroom/conference room setting and include information on such topics as blood pressure, reading food labels, healthy eating, and memory. The class will be a PowerPoint presentation with incorporated question/answer, lively discussion, and group-bonding activities. Following completion of the 12-week intervention, all participants will be asked to complete the same baseline tests to assess changes in physical function, body composition, quality of life, and cognitive function outcomes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Velocity Resistance Training | Behavioral | High-velocity resistance training for patients with non-dialysis dependent chronic kidney disease Stages 3-5 with mobility limitations. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled | Number of participants enrolled with a goal of 30. | Month 6 |
| Percent of Participant Adherence | Percentage of exercise sessions attended for the HVRT group (out of 36 total exercise sessions) | Week 13 |
| Percent of Participant Retention | Percentage of participants retained at the final follow visit. | Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) Score | The short physical performance battery (SPPB) consists of three tests to assess lower extremity function: a balance test, a gait speed test, and a sit-to-stand test. Performance in each test will be assigned a score ranging from 0 to 4 points, and these scores will be summed to calculate the SPPB score out of 12. A higher SPPB score indicates better function, and scores of 10 or lower are indicative of high risk of disability. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Appendicular Lean Mass | Appendicular Lean Mass (kg/m^2) will be measured via dual-energy X-ray absorptiometry (DXA). Higher appendicular lean mass is indicative of improved body composition. | From baseline to Follow-up (Week 13) |
| Change in isometric leg extension strength |
Inclusion Criteria:
Exclusion Criteria:
Acute myocardial infarction within the past 6 months Ongoing unstable angina Uncontrolled cardiac arrhythmia with hemodynamic compromise Active endocarditis Symptomatic severe aortic stenosis Decompensated heart failure Acute pulmonary embolism, pulmonary infarction, or deep venous thrombosis Acute myocarditis or pericarditis Acute aortic dissection
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenna Lauderback | Contact | 336-758-3784 | epicstudy@wfu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eliott Arroyo, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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| Attention | Behavioral | Dedicated contact, information, and motivation throughout the course of the study via weekly group sessions and informational handouts. |
|
| From baseline to Follow-up (Week 13) |
| Change in Timed Up and Go Test duration | For the timed up-and-go test, the time to complete this task will be measured in seconds. A lower number of seconds to complete the task is indicative of higher physical function. | From baseline to Follow-up (Week 13) |
| Change in lower body peak power | Leg press peak power will be assessed at 5 relative intensities (40%, 50%, 60%, 70%, and 80% 1-repetition maximum). The highest peak power measurement among those 5 loads will be recorded as peak power. Greater peak power is indicative of greater lower body neuromuscular function. | From baseline to Follow-up (Week 13) |
Isometric leg extension strength will be measured with a maximal isometric voluntary contraction of the dominant leg knee extensor muscles using a MicroFET2 hand-held dynamometer. Greater peak force is indicative of greater knee extensor strength. |
| From baseline to Follow-up (Week 13) |
| Change in lower body strength | Lower body strength will be measured as the 1-repetition maximum on the leg press, which is the maximum load (kg) that can be moved 1 time only throughout the full range of motion. Increase in leg press 1-repetition maximum is indicative of improved lower body strength. | From baseline to Follow-up (Week 13) |
| Change in lower body muscle endurance | Lower body muscle endurance will be measured on the leg press as the maximum number of repetitions completed at a load of 70% of baseline 1-repetition maximum with a fixed cadence of 60 bpm. An increase in the number of repetitions completed is indicative of an improvement in lower body muscle endurance. | From baseline to Follow-up (Week 13) |
| Change in muscle activation | Muscle activation of knee extensors (rectus femoris, vastus medialis, and vastus lateralis) will be assessed by surface electromyography (EMG) during the maximal voluntary contraction (MVC) and during the leg press exercise testing. An increase in the peak EMG root-mean-square amplitude relative to the amplitude during MVC (%MVC) is indicative of greater muscle activation. | From baseline to Follow-up (Week 13) |
| Change in average daily steps | An ActivPAL 4 triaxial accelerometer will be worn on the midline of the non-dominant thigh for 7 consecutive days prior to the start of the intervention and during the final week of the intervention. An increase in the average number of steps per day is indicative of increased physical activity level. | From baseline to Follow-up (Week 13) |
| Change in average daily minutes spent sedentary | The average number of minutes spent in sedentary behavior per day will be measured with an ActivPAL 4 triaxial accelerometer. An decrease in the average number of minutes spent in sedentary behavior per day is indicative of a decrease in sedentary activity. | From baseline to Follow-up (Week 13) |
| Change in average daily minutes spent stepping | The average number of minutes spent stepping per day will be measured with an ActivPAL 4 triaxial accelerometer. An increase in the number of minutes spent stepping per day is indicative of an increase in physical activity. | From baseline to Follow-up (Week 13) |
| Change in average daily minutes spent stepping above 75 steps per minute and 100 steps per minute | The average number of minutes spent stepping above 75 steps per minute and 100 steps per minute per day will be measured with an ActivPAL 4 triaxial accelerometer. An increase in the number of minutes spent stepping above 75 steps per minute and 100 steps per minute is indicative of an increase in moderate-to-vigorous intensity physical activity. | From baseline to Follow-up (Week 13) |
| Change in Symbol Digit Coding Test Score | The Symbol Digit Coding Test measures complex information processing accuracy, complex attention, visual-perceptual speed, and information processing speed. The score is the number of correct symbols drawn within a period of 120 seconds. One point is given for each correctly drawn symbol completed within the time limit. The maximum score is 133. High scores indicate higher cognitive functioning. | From baseline to Follow-up (Week 13) |
| Change in Four-Part Continuous Performance | The 4PCPT test is a four-part test that measures a subject's working memory and sustained attention. Higher scores indicate higher cognitive functioning. | From baseline to Follow-up (Week 13) |
| Change in Shifting Attention Test Score | SAT test is a measure of ability to shift from one instruction set to another quickly and accurately. Higher scores indicate higher cognitive functioning. | From baseline to Follow-up (Week 13) |
| Change in Stroop Test Score | Stroop test has three parts. Higher scores indicate higher cognitive functioning. | From baseline to Follow-up (Week 13) |
| Change in Kidney Disease Quality of Life Short Form (KDQOL-SF) Scores | The KDQOL-SF version 1.3 is a self-report measure developed for individuals with kidney disease. It includes 43 kidney-disease targeted items as well as 36 items that provide a generic core and an overall health rating item. 0-100 possible range, with higher scores always reflecting better quality of life. | From baseline to Follow-up (Week 13) |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |