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

Primary Purpose

Cognitive Impairment, End-Stage Renal Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Standard Care Dialysis
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment focused on measuring ESRD, Kidney Failure, Exercise, Cognitive impairment

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise Group

Control Group

Arm Description

Subjects randomized to this group will start 12 weeks of supervised aerobic exercise after baseline testing.

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.

Outcomes

Primary Outcome Measures

Feasibility
Subject compliance with exercise training

Secondary Outcome Measures

Cognitive function
Measured using a standard battery of neuropsychological tests.
Markers of inflammation
Markers of inflammation will be evaluated before and after exercise intervention

Full Information

First Posted
May 17, 2014
Last Updated
March 27, 2019
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02145702
Brief Title
Impact of Exercise on Cognitive Impairment in End-Stage Renal Disease
Official Title
Impact of Exercise on Cognitive Impairment in End-Stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Funding has expired
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, End-Stage Renal Disease
Keywords
ESRD, Kidney Failure, Exercise, Cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Subjects randomized to this group will start 12 weeks of supervised aerobic exercise after baseline testing.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard Care Dialysis
Intervention Description
12 weeks of standard of care.
Primary Outcome Measure Information:
Title
Feasibility
Description
Subject compliance with exercise training
Time Frame
Up to 26 Weeks
Secondary Outcome Measure Information:
Title
Cognitive function
Description
Measured using a standard battery of neuropsychological tests.
Time Frame
Baseline, within1 week before and within 1 week after exercise intervention
Title
Markers of inflammation
Description
Markers of inflammation will be evaluated before and after exercise intervention
Time Frame
Baseline, within 1 week before and within 1 week after exercise intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aditi Gupta, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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

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