Impact of Exercise on Cognitive Impairment in End-Stage Renal Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in patients with end stage renal disease.

Detailed Description
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Patients with end stage renal disease have higher cognitive impairment than general population. They also have decreased physical and functional capacity. Exercise has shown to improve cognition in general population. This study will evaluate if exercise improves cognition in dialysis patients. It will also evaluate whether exercise affects performance in daily activities, mood or depression and inflammatory markers in the blood.

Official Title
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Impact of Exercise on Cognitive Impairment in End-Stage Renal Disease

Conditions
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Cognitive Impairment, End-Stage Renal Disease

Intervention / Treatment
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* Other: Aerobic Exercise
* Procedure: Standard Care Dialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ESRD on dialysis Age greater than 20 years Have means of transportation to and from the exercise session Speak English (as the neuropsychological tests will be performed in English) Exclusion Criteria: Recent myocardial infarction (within 6 weeks), unstable angina, uncontrolled arrhythmias, congestive heart failure (> NYHA grade II) History of stroke in the last 2 months Active respiratory disease Uncontrolled hypertension Severe uncontrolled diabetes Persistent predialysis hyperkalemia Active decompensated liver disease Symptomatic peripheral vascular disease Musculoskeletal abnormalities that will be prohibit their participation in the exercise program Health conditions needing frequent hospitalizations Other health conditions causing inability to follow exercise program correctly Unwillingness to participate in structured exercise program Current use of antipsychotics or anti-epileptics Inability to hear, read or write which will limit their ability to perform the cognitive tests

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group<br>Subjects randomized to this group will start 12 weeks of supervised aerobic exercise after baseline testing. | Other: Aerobic Exercise<br>* Each exercise session will be conducted at the KUMC Exercise and Cardiovascular Health (REACH) Laboratory. Exercise sessions will include a warm-up period, exercise period and a cool down period. Exercise intervention individualized based on health of participant. Subject will be asked to completed two exercise sessions per week for 12 weeks.<br>|
| Experimental: Control Group<br>Subjects randomized to this group will continue with 12 weeks of Standard Care. After 12 weeks, the subjects will cross over to the exercise arm and undergo baseline testing again and then start 12 weeks of exercise intervention. | Other: Aerobic Exercise<br>* Each exercise session will be conducted at the KUMC Exercise and Cardiovascular Health (REACH) Laboratory. Exercise sessions will include a warm-up period, exercise period and a cool down period. Exercise intervention individualized based on health of participant. Subject will be asked to completed two exercise sessions per week for 12 weeks.<br>Procedure: Standard Care Dialysis<br>* 12 weeks of standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Subject compliance with exercise training | Up to 26 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Measured using a standard battery of neuropsychological tests. | Baseline, within1 week before and within 1 week after exercise intervention | 
| Markers of inflammation | Markers of inflammation will be evaluated before and after exercise intervention | Baseline, within 1 week before and within 1 week after exercise intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, Kidney Failure, Exercise, Cognitive impairment