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

Not Applicable

Terminated

• Conditions: End-Stage Renal Disease; Cognitive Impairment
• Interventions: Other: Aerobic Exercise; Procedure: Standard Care Dialysis

• Registration Number: NCT02145702
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-17
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-23
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group	Aerobic Exercise	Subjects randomized to this group will start 12 weeks of supervised aerobic exercise after baseline testing.
Control Group	Standard Care Dialysis	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.
Control Group	Aerobic Exercise	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.

Primary Outcome Measures

Name	Time	Method
Feasibility	Up to 26 Weeks	Subject compliance with exercise training

Secondary Outcome Measures

Name	Time	Method
Markers of inflammation	Baseline, within 1 week before and within 1 week after exercise intervention	Markers of inflammation will be evaluated before and after exercise intervention
Cognitive function	Baseline, within1 week before and within 1 week after exercise intervention	Measured using a standard battery of neuropsychological tests.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States